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Patricia LoRusso, DO

Professor of Medicine (Medical Oncology); Chief, Experimental Therapeutics; Associate Cancer Center Director, Experimental Therapeutics

Contact Information

Patricia LoRusso, DO

Mailing Address

  • Yale Cancer Center

    333 Cedar Street, WWW217

    New Haven, CT 06520

    United States

Research Summary

LoRusso has served as co-chair of the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Investigational Drug Steering Committee. She also served on the scientific committee of the American Association for Cancer Research (AACR), the education and scientific committees of the American Society of Clinical Oncology (ASCO), numerous peer-reviewed study sections, and NCI committees. She has garnered numerous awards, including the 1999 Heroes of Breast Cancer Award; 2004 Bennett J. Cohen Educational Leadership Award for Medical Research, 2008 NCI Michaele C. Christian Oncology Development Lectureship and Award; the 2014 Targeted Anticancer Therapies (TAT) Honorary Award; and will receive the 2014 Michigan State University Distinguished Alumni Award. She was recently honored as one of the 2014 Massachusetts General Hospital Cancer Center’s “One Hundred” individuals and organizations recognized for their dedication in making a difference in the fight against cancer. LoRusso is a former editor of Investigational New Drugs, is currently on the editorial board for Clinical Cancer Research, and is a reviewer for several journals. She has authored more than 200 articles on cancer research in peer-reviewed journals, and written multiple book chapters.

Extensive Research Description

LoRusso has served as co-chair of the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Investigational Drug Steering Committee. She also served on the scientific committee of the American Association for Cancer Research (AACR), the education and scientific committees of the American Society of Clinical Oncology (ASCO), numerous peer-reviewed study sections, and NCI committees. She has garnered numerous awards, including the 1999 Heroes of Breast Cancer Award; 2004 Bennett J. Cohen Educational Leadership Award for Medical Research, 2008 NCI Michaele C. Christian Oncology Development Lectureship and Award; the 2014 Targeted Anticancer Therapies (TAT) Honorary Award; and will receive the 2014 Michigan State University Distinguished Alumni Award. She was recently honored as one of the 2014 Massachusetts General Hospital Cancer Center’s “One Hundred” individuals and organizations recognized for their dedication in making a difference in the fight against cancer. LoRusso is a former editor of Investigational New Drugs, is currently on the editorial board for Clinical Cancer Research, and is a reviewer for several journals. She has authored more than 200 articles on cancer research in peer-reviewed journals, and written multiple book chapters.

Interventional oncology; Liver cancer

Coauthors

Research Interests

Clinical Trial, Phase I; Regenerative Medicine

Selected Publications

  • 172P Phase I study of JTX-8064, a LILRB2 (ILT4) inhibitor, as monotherapy and combination with pimivalimab (pimi), a PD-1 inhibitor (PD-1i), in patients (pts) with advanced solid tumorsPapadopoulos K, Li T, Lakhani N, Powderly J, George T, Teoh D, Kilari D, Giaccone G, Sanborn R, Ghamande S, LoRusso P, Gibney G, Ma V, Yalamanchili K, Brown J, Mota N, Kadra C, Umiker B, Xiao X, Trehu E. 172P Phase I study of JTX-8064, a LILRB2 (ILT4) inhibitor, as monotherapy and combination with pimivalimab (pimi), a PD-1 inhibitor (PD-1i), in patients (pts) with advanced solid tumors Immuno-Oncology Technology 2022, 16: 100284. DOI: 10.1016/j.iotech.2022.100284.
  • 770 Safety, efficacy, and pharmacokinetic results from a phase I first-in-human study of ABBV-151 with or without anti-PD1 mAb (budigalimab) in patients with locally advanced or metastatic solid tumorsTolcher A, Roda-Perez D, He K, Moreno V, Gomez-Roca C, Machiels J, Razak A, Sahtout M, Guan X, Jaryno-Daly S, Leibman R, Blaney M, O’Brien J, Lorusso P, Powderly J, Golan T, Miller K, Bruix J. 770 Safety, efficacy, and pharmacokinetic results from a phase I first-in-human study of ABBV-151 with or without anti-PD1 mAb (budigalimab) in patients with locally advanced or metastatic solid tumors 2022, a800-a800. DOI: 10.1136/jitc-2022-sitc2022.0770.
  • Financial toxicity in patients with advanced solid malignancies participating in early-phase clinical trials.Blanter J, Werner M, Kier M, Hapanowicz O, Itani M, Ahmad M, DeMerchant M, Eder J, Galsky M, Hammad A, King P, Lachowicz M, Lucas N, Marron T, Shelton G, Wu K, Xu S, LoRusso P, Hofstatter E, Doroshow D. Financial toxicity in patients with advanced solid malignancies participating in early-phase clinical trials. Journal Of Clinical Oncology 2022, 40: 267-267. DOI: 10.1200/jco.2022.40.28_suppl.267.
  • OA03.04 Phase I A Study to Evaluate GDC-6036 Monotherapy in Patients with Non-small Cell Lung Cancer (NSCLC) with KRAS G12C MutationSacher A, Patel M, Miller W, Desai J, Garralda E, Bowyer S, Kim T, De Miguel M, Falcon A, Krebs M, Lee J, Cheng M, Han S, Shacham-Shmueli E, Forster M, Jerusalem G, Massarelli E, Rodriguez L, Prenen H, Walpole I, Arbour K, Choi Y, Dharia N, Lin M, Mandlekar S, Joo S, Shi Z, Schutzman J, LoRusso P. OA03.04 Phase I A Study to Evaluate GDC-6036 Monotherapy in Patients with Non-small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation Journal Of Thoracic Oncology 2022, 17: s8-s9. DOI: 10.1016/j.jtho.2022.07.023.
  • 85P A circulating, surrogate-systemic biomarker correlates with anti-tumor benefit on LNS8801 therapyCohen J, Natale C, Lin J, Lorusso P, Mita A, Mita M, Muller C, Orloff M, Papadopoulos K, Rodon J, Garyantes T. 85P A circulating, surrogate-systemic biomarker correlates with anti-tumor benefit on LNS8801 therapy Annals Of Oncology 2022, 33: s578-s579. DOI: 10.1016/j.annonc.2022.07.117.
  • 1669P Monitoring immune checkpoint inhibition in advanced solid tumors using genome-wide cfDNA fragmentomesMedina J, Torres E, Leal A, Adleff V, Lumbard K, Keefer L, Carey J, Brufsky A, Lorusso P, Eder J, Chung V, Downs M, O'Connor A, Piekarz R, Streicher H, Jaffee E, Scharpf R, Stearns V, Connolly R, Velculescu V. 1669P Monitoring immune checkpoint inhibition in advanced solid tumors using genome-wide cfDNA fragmentomes Annals Of Oncology 2022, 33: s1306-s1307. DOI: 10.1016/j.annonc.2022.07.1749.
  • 362P Phase Ia study to evaluate GDC-6036 monotherapy in patients with colorectal cancer (CRC) with KRAS G12C mutationDesai J, Han S, Forster M, Kim T, Casal G, Shmueli E, Bowyer S, De Miguel M, Gonzalez A, Jones R, Krebs M, Miller W, Paz-Ares L, Lorusso P, Sacher A, Dharia N, Lin M, Schutzman J, Shi Z, Patel M. 362P Phase Ia study to evaluate GDC-6036 monotherapy in patients with colorectal cancer (CRC) with KRAS G12C mutation Annals Of Oncology 2022, 33: s701-s702. DOI: 10.1016/j.annonc.2022.07.500.
  • 452O A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumoursSchoeffski P, Yamamoto N, Bauer T, Patel M, Gounder M, Geng J, Sailer R, Jayadeva G, Lorusso P. 452O A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumours Annals Of Oncology 2022, 33: s743. DOI: 10.1016/j.annonc.2022.07.581.
  • 459MO Phase Ia study to evaluate GDC-6036 monotherapy in patients with solid tumors with a KRAS G12C mutationPatel M, Lee J, De Miguel M, Burns T, Gonzalez A, Kim T, Krebs M, Prenen H, Shmueli E, Desai J, Lorusso P, Sacher A, Choi Y, Dharia N, Lin M, Mandlekar S, Royer-Joo S, Schutzman J, Garralda E. 459MO Phase Ia study to evaluate GDC-6036 monotherapy in patients with solid tumors with a KRAS G12C mutation Annals Of Oncology 2022, 33: s749. DOI: 10.1016/j.annonc.2022.07.588.
  • 732MO The combination of ICT01, a γ9δ2 T cell-activating mAb, plus pembrolizumab induces a broad antitumor immune response and disease control in patients with CPI-failure melanoma, NSCLC and bladder cancer: EVICTION trialChampiat S, Wermke M, Vicier C, de Bono J, Jungels C, Vey N, Kotecki N, Wetzko K, Ruhnke L, Garralda E, de Aguiar V, Lorusso P, de Gassart A, Valentin E, Brune P, Iche M, Leparquier C, Olive D, Marabelle A, Frohna P. 732MO The combination of ICT01, a γ9δ2 T cell-activating mAb, plus pembrolizumab induces a broad antitumor immune response and disease control in patients with CPI-failure melanoma, NSCLC and bladder cancer: EVICTION trial Annals Of Oncology 2022, 33: s877-s878. DOI: 10.1016/j.annonc.2022.07.858.
  • Abstract CT170: A phase 1/2 study of olaparib in combination with ramucirumab in metastatic gastric and gastroesophageal junction adenocarcinoma (GEJ)Cecchini M, Chao J, Shyr Y, Cleary J, Uboha N, Cho M, Shields A, Pant S, Goff L, Spencer K, Kim E, Hsu C, Stein S, Thumar J, Kortmansky J, Kunstman J, LoRusso P, Ivy P, Lacy J. Abstract CT170: A phase 1/2 study of olaparib in combination with ramucirumab in metastatic gastric and gastroesophageal junction adenocarcinoma (GEJ) Cancer Research 2022, 82: ct170-ct170. DOI: 10.1158/1538-7445.am2022-ct170.
  • Abstract 1836: RBN-2397, a novel, potent, and selective PARP7 inhibitor, induces tumor-intrinsic type I interferon responses and adaptive immunity in patient tumorsKuplast-Barr K, Johnson M, Patel M, Yap T, Falchook G, LoRusso P, Abo R, Liu C, Manyak E, Cleary L, Bozon V, Parasuraman S, Keilhack H, McEachern K. Abstract 1836: RBN-2397, a novel, potent, and selective PARP7 inhibitor, induces tumor-intrinsic type I interferon responses and adaptive immunity in patient tumors Cancer Research 2022, 82: 1836-1836. DOI: 10.1158/1538-7445.am2022-1836.
  • Abstract 4151: Effect of camidanlumab tesirine (Cami) as monotherapy and in combination with pembrolizumab (PEM) on the immune cell profile in patients with selected advanced solid tumorsPuzanov I, Chen C, LoRusso P, Papadopoulos K, Kummar S, Hamilton E, LeBruchec Y, Havenith K, Pantano S, Toukam M, Wuerthner J, Boni J. Abstract 4151: Effect of camidanlumab tesirine (Cami) as monotherapy and in combination with pembrolizumab (PEM) on the immune cell profile in patients with selected advanced solid tumors Cancer Research 2022, 82: 4151-4151. DOI: 10.1158/1538-7445.am2022-4151.
  • Abstract CT040: SOT101, an IL-2/IL-15 Rβγ superagonist, in combination with pembrolizumab in patients with advanced solid tumors: Interim safety and efficacy results from the AURELIO-03 dose escalation trialChampiat S, Marabelle A, Galvao V, LoRusso P, Grell P, Cassier P, Gomez-Roca C, Korakis I, Naing A, Jelinkova L, Adkins I, Moebius U, Sachse R, Tillmanns S, Bechard D, Kiemle-Kallee J, Garralda E. Abstract CT040: SOT101, an IL-2/IL-15 Rβγ superagonist, in combination with pembrolizumab in patients with advanced solid tumors: Interim safety and efficacy results from the AURELIO-03 dose escalation trial Cancer Research 2022, 82: ct040-ct040. DOI: 10.1158/1538-7445.am2022-ct040.
  • Abstract CT188: ICT01, an anti-butyrophilin 3A targeted mAb activating g9d2 T cells, induces immune remodeling of the tumor microenvironment and clinical responses in combination with pembrolizumab in patients with advanced solid tumors who failed prior checkpoint inhibitor therapy: EVICTION TrialChampiat S, Wermke M, de Bono J, Marabelle A, Jungels C, Vicier C, Vey N, List C, Wetzko K, Ruhnke L, Garralda E, de Aguiar V, LoRusso P, Kotecki N, De Gassart A, Valentin E, Brune P, Iché M, Leparquier C, Olive D, Frohna P. Abstract CT188: ICT01, an anti-butyrophilin 3A targeted mAb activating g9d2 T cells, induces immune remodeling of the tumor microenvironment and clinical responses in combination with pembrolizumab in patients with advanced solid tumors who failed prior checkpoint inhibitor therapy: EVICTION Trial Cancer Research 2022, 82: ct188-ct188. DOI: 10.1158/1538-7445.am2022-ct188.
  • Multicenter phase 2 trial of the PARP inhibitor (PARPi) olaparib in recurrent IDH1 and IDH2-mutant contrast-enhancing glioma.Fanucci K, Pilat M, Shah R, Boerner S, Li J, Durecki D, Drappatz J, Collichio F, Puduvalli V, Lieberman F, Gonzalez J, Giglio P, Bao X, Ivy S, Bindra R, Omuro A, LoRusso P. Multicenter phase 2 trial of the PARP inhibitor (PARPi) olaparib in recurrent IDH1 and IDH2-mutant contrast-enhancing glioma. Journal Of Clinical Oncology 2022, 40: 2035-2035. DOI: 10.1200/jco.2022.40.16_suppl.2035.
  • Interim safety and efficacy results from AURELIO-03: A phase 1 dose escalation study of the IL-2/IL-15 receptor βγ superagonist SOT101 as a single agent and in combination with pembrolizumab in patients with advanced solid tumors.Garralda E, Naing A, Galvao V, LoRusso P, Grell P, Cassier P, Gomez-Roca C, Korakis I, Bechard D, Palova Jelinkova L, Adkins I, Tillmanns S, Kiemle-Kallee J, Marabelle A, Champiat S. Interim safety and efficacy results from AURELIO-03: A phase 1 dose escalation study of the IL-2/IL-15 receptor βγ superagonist SOT101 as a single agent and in combination with pembrolizumab in patients with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 2502-2502. DOI: 10.1200/jco.2022.40.16_suppl.2502.
  • Phase 1 trial of TIM-3 inhibitor cobolimab monotherapy and in combination with PD-1 inhibitors nivolumab or dostarlimab (AMBER).Falchook G, Ribas A, Davar D, Eroglu Z, Wang J, Luke J, Hamilton E, Di Pace B, Wang T, Ghosh S, Dhar A, Borgovan T, Waszak A, LoRusso P. Phase 1 trial of TIM-3 inhibitor cobolimab monotherapy and in combination with PD-1 inhibitors nivolumab or dostarlimab (AMBER). Journal Of Clinical Oncology 2022, 40: 2504-2504. DOI: 10.1200/jco.2022.40.16_suppl.2504.
  • A phase 1b, multicenter, dose-escalation study of subasumstat (TAK-981) in combination with pembrolizumab in patients (pts) with advanced solid tumors.Goel S, Ulahannan S, Olszanski A, LoRusso P, Sanborn R, Sharma S, Emens L, Reilley M, Priego V, Li S, Wang B, Dong L, Sachsenmeier K, Gibbs J, Gharavi R, Martinez A, Proscurshim I, Fram R, Gomez-Pinillos A, Rasco D. A phase 1b, multicenter, dose-escalation study of subasumstat (TAK-981) in combination with pembrolizumab in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 2506-2506. DOI: 10.1200/jco.2022.40.16_suppl.2506.
  • Phase 1b study of the novel first-in-class G protein-coupled estrogen receptor (GPER) agonist, LNS8801, in combination with pembrolizumab in patients with immune checkpoint inhibitor (ICI)-relapsed and refractory solid malignancies and dose escalation update.Muller C, Chaney M, Cohen J, Garyantes T, Lin J, LoRusso P, Mita A, Mita M, Natale C, Orloff M, Papadopoulos K, Patel S, Rodon Ahnert J. Phase 1b study of the novel first-in-class G protein-coupled estrogen receptor (GPER) agonist, LNS8801, in combination with pembrolizumab in patients with immune checkpoint inhibitor (ICI)-relapsed and refractory solid malignancies and dose escalation update. Journal Of Clinical Oncology 2022, 40: 2574-2574. DOI: 10.1200/jco.2022.40.16_suppl.2574.
  • A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients with solid tumors, including advanced/metastatic liposarcoma (LPS).Gounder M, Yamamoto N, Patel M, Bauer T, Schöffski P, Grempler R, Durland-Busbice S, Geng J, Maerten A, LoRusso P. A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients with solid tumors, including advanced/metastatic liposarcoma (LPS). Journal Of Clinical Oncology 2022, 40: 3004-3004. DOI: 10.1200/jco.2022.40.16_suppl.3004.
  • NCI 9938: Phase I clinical trial of ATR inhibitor berzosertib (M6620, VX-970) in combination with irinotecan in patients with advanced solid tumors.Villaruz L, Kelly K, Waqar S, Davis E, Shapiro G, LoRusso P, Dees E, Normolle D, Rhee J, Chu E, Gore S, Beumer J. NCI 9938: Phase I clinical trial of ATR inhibitor berzosertib (M6620, VX-970) in combination with irinotecan in patients with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 3012-3012. DOI: 10.1200/jco.2022.40.16_suppl.3012.
  • A first-in-human, phase 1 study of ASTX029, a dual-mechanism inhibitor of ERK1/2, in relapsed/refractory solid tumors.LoRusso P, Rasco D, Shapiro G, Mita A, Azad N, Swiecicki P, El-Khoueiry A, Gandara D, Kummar S, Tanajian H, Taylor J, Bottone F, Toguchi M, Hindley C, Chan D, Oganesian A, Keer H, Dao K, Sullivan R, Spira A. A first-in-human, phase 1 study of ASTX029, a dual-mechanism inhibitor of ERK1/2, in relapsed/refractory solid tumors. Journal Of Clinical Oncology 2022, 40: 9085-9085. DOI: 10.1200/jco.2022.40.16_suppl.9085.
  • Phase 1 study of SGN-ALPV, a novel, investigational vedotin antibody–drug conjugate directed to ALPP/ALPPL2 in advanced solid tumors (SGNALPV-001, trial in progress).Lakhani N, Friedman C, Perez C, Wehr A, McGoldrick S, LoRusso P. Phase 1 study of SGN-ALPV, a novel, investigational vedotin antibody–drug conjugate directed to ALPP/ALPPL2 in advanced solid tumors (SGNALPV-001, trial in progress). Journal Of Clinical Oncology 2022, 40: tps3159-tps3159. DOI: 10.1200/jco.2022.40.16_suppl.tps3159.
  • Abstract P2-13-25: A phase I dose-escalation study of DHES0815A, a HER2-targeting antibody-drug conjugate with a DNA monoalkylator payload, in patients with HER2-positive breast cancerKrop I, Hamilton E, Jung K, Modi S, Kalinsky K, Phillips G, Shi R, Monemi S, Mamounas M, Saad O, Choeurng V, Commerford R, Cho E, Ungewickell A, LoRusso P. Abstract P2-13-25: A phase I dose-escalation study of DHES0815A, a HER2-targeting antibody-drug conjugate with a DNA monoalkylator payload, in patients with HER2-positive breast cancer Cancer Research 2022, 82: p2-13-25-p2-13-25. DOI: 10.1158/1538-7445.sabcs21-p2-13-25.
  • 516 Peripheral and tumoral immune activity in the expansion part of the first-in-human DuoBody®-PD-L1×4–1BB (GEN1046) trialAix S, Calvo E, Moreno V, Garralda E, Cervantes A, Ramalingam S, Pérez J, LoRusso P, Furqan M, Cho D, Muik A, Lagkadinou E, Türeci Ö, Couto S, Pencheva N, Forssmann U, Şahin U, Ahmadi T, Higgs B, Jure-Kunkel M, Melero I. 516 Peripheral and tumoral immune activity in the expansion part of the first-in-human DuoBody®-PD-L1×4–1BB (GEN1046) trial Journal For ImmunoTherapy Of Cancer 2021, 9: a546-a546. DOI: 10.1136/jitc-2021-sitc2021.516.
  • 866 RBN-2397, a novel, potent, and selective PARP7 inhibitor, induces tumor-intrinsic type I interferon responses and adaptive immunity in preclinical models and patient tumorsKuplast-Barr K, Kuplast-Barr K, Johnson M, Patel M, Yap T, Falchook G, LoRusso P, Abo R, Liu C, Manyak E, Cleary L, Bozon V, Parasuraman S, Keilhack H, McEachern K. 866 RBN-2397, a novel, potent, and selective PARP7 inhibitor, induces tumor-intrinsic type I interferon responses and adaptive immunity in preclinical models and patient tumors Journal For ImmunoTherapy Of Cancer 2021, 9: a907-a907. DOI: 10.1136/jitc-2021-sitc2021.866.
  • 498 Evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with head and neck squamous cell carcinoma (HNSCC) and with gastric/gastroesophageal cancer (GC); ASPEN-01Lee K, Chung H, Kim T, Lakhani N, Messersmith W, Santana-Davila R, Kim W, LoRusso P, Bang Y, Chow L, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, Gainor J. 498 Evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with head and neck squamous cell carcinoma (HNSCC) and with gastric/gastroesophageal cancer (GC); ASPEN-01 Journal For ImmunoTherapy Of Cancer 2021, 9: a530-a530. DOI: 10.1136/jitc-2021-sitc2021.498.
  • 493 First-in-human phase 1/2 trial to evaluate the safety and initial clinical activity of DuoBody®-CD40×4–1BB (GEN1042) in patients with advanced solid tumorsJohnson M, Lopez J, LoRusso P, Bauman J, Haggstrom D, Lagkadinou E, Bajaj G, Türeci Ö, Adams H, Şahin U, Fu Y, Ahmadi T, Rohrberg K. 493 First-in-human phase 1/2 trial to evaluate the safety and initial clinical activity of DuoBody®-CD40×4–1BB (GEN1042) in patients with advanced solid tumors Journal For ImmunoTherapy Of Cancer 2021, 9: a525-a525. DOI: 10.1136/jitc-2021-sitc2021.493.
  • 484 Preliminary efficacy of the IL-15 superagonist SO-C101 in combination with pembrolizumab in patients with advanced/metastatic solid tumorsGarralda E, Galvao V, Champiat S, LoRusso P, Grell P, Naing A, Janku F, Sachse R, Bechard D, Kiemle-Kallee J, Marabelle A, Garralda E. 484 Preliminary efficacy of the IL-15 superagonist SO-C101 in combination with pembrolizumab in patients with advanced/metastatic solid tumors Journal For ImmunoTherapy Of Cancer 2021, 9: a514-a514. DOI: 10.1136/jitc-2021-sitc2021.484.
  • 502 Recommended phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the IL-15 superagonist SO-C101 as monotherapy in patients with advanced/metastatic solid tumorsMarabelle A, Champiat S, Galvao V, Naing A, Janku F, LoRusso P, Grell P, Sachse R, Bechard D, Kiemle-Kallee J, Garralda E. 502 Recommended phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the IL-15 superagonist SO-C101 as monotherapy in patients with advanced/metastatic solid tumors Journal For ImmunoTherapy Of Cancer 2021, 9: a534-a534. DOI: 10.1136/jitc-2021-sitc2021.502.
  • 503 Clinical activity of ICT01, an anti-BTN3A-targeted, γ9δ2-activating mAb, alone and in combination with pembrolizumab in patients with advanced/refractory solid tumors: EVICTION trialWermke M, Marabelle A, Jungels C, Bono J, Vey N, Vicier C, Garralda E, Gouill S, LoRusso P, Champiat S, List C, Aguiar V, Wetzko K, Rhunke L, Gassart A, Brune P, Valentin E, Iche M, Olive D, Frohna P. 503 Clinical activity of ICT01, an anti-BTN3A-targeted, γ9δ2-activating mAb, alone and in combination with pembrolizumab in patients with advanced/refractory solid tumors: EVICTION trial Journal For ImmunoTherapy Of Cancer 2021, 9: a535-a535. DOI: 10.1136/jitc-2021-sitc2021.503.
  • 539 Phase 1 study of mRNA-2752, a lipid nanoparticle encapsulating mRNAs encoding human OX40L/IL-23/IL-36γ, for intratumoral (ITu) injection +/- durvalumab in advanced solid tumors and lymphomaPatel M, Jimeno A, Wang D, Stemmer S, Bauer T, Sweis R, Geva R, Kummar S, Reagan P, Perets R, LoRusso P, Gupta S, Zacharek S, Laino A, Milberg O, Frederick J, Chen S, Pascarella S, Randolph W, Aanur P, Johansen L, Do K, Meehan R, Sullivan R. 539 Phase 1 study of mRNA-2752, a lipid nanoparticle encapsulating mRNAs encoding human OX40L/IL-23/IL-36γ, for intratumoral (ITu) injection +/- durvalumab in advanced solid tumors and lymphoma Journal For ImmunoTherapy Of Cancer 2021, 9: a569-a569. DOI: 10.1136/jitc-2021-sitc2021.539.
  • 1033TiP A first-in-human phase I study of FS120, an OX40/CD137 tetravalent bispecific antibody, in patients with advanced malignanciesPapadopoulos K, Yap T, Piha-Paul S, Lorusso P, Hu-Lieskovan S, Shepherd C, Marshall S, Holz J, Poon E, Grabowska U, Kayitalire L. 1033TiP A first-in-human phase I study of FS120, an OX40/CD137 tetravalent bispecific antibody, in patients with advanced malignancies Annals Of Oncology 2021, 32: s864-s865. DOI: 10.1016/j.annonc.2021.08.1417.
  • 958O Coordinated activation of antitumor responses of g9d2 and CD8 T-cells by targeting BTN3A with ICT01 in patients with solid tumors: EVICTION trialMarabelle A, Wermke M, Jungels C, de Bono J, Vey N, Garralda E, Lorusso P, Olive D, Frohna P. 958O Coordinated activation of antitumor responses of g9d2 and CD8 T-cells by targeting BTN3A with ICT01 in patients with solid tumors: EVICTION trial Annals Of Oncology 2021, 32: s829-s830. DOI: 10.1016/j.annonc.2021.08.1343.
  • 964MO Entinostat, nivolumab and ipilimumab in advanced HER2-negative breast cancer (ETCTN-9844)Torres E, Leatherman J, Rafie C, Brufsky A, Lorusso P, Eder J, Chung V, Yuan Y, Downs M, O’Connor A, Piekarz R, Streicher H, Rudek M, Zhu Q, Fertig E, Anders R, Cimino-Mathews A, Jaffee E, Stearns V, Connolly R. 964MO Entinostat, nivolumab and ipilimumab in advanced HER2-negative breast cancer (ETCTN-9844) Annals Of Oncology 2021, 32: s833. DOI: 10.1016/j.annonc.2021.08.1349.
  • 1548P A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients (pts) with advanced/metastatic sarcomaGounder M, Patel M, Yamamoto N, Bauer T, Laurie S, Perez-Pitarch A, Geng J, Cheng J, Lahmar M, Lorusso P. 1548P A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients (pts) with advanced/metastatic sarcoma Annals Of Oncology 2021, 32: s1124-s1125. DOI: 10.1016/j.annonc.2021.08.878.
  • MO24-1 Phase I/IIa trial evaluating safety and clinical activity of DuoBody®-PD-L1×4-1BB (GEN1046) in advanced solid tumorsMelero I, Geva R, Ben-Ami E, Maurice-Dror C, Calvo E, LoRusso P, Tureci O, Niewood M, Sahin U, Jure-Kunkel M, Forssmann U, Ahmadi T, Alonso G. MO24-1 Phase I/IIa trial evaluating safety and clinical activity of DuoBody®-PD-L1×4-1BB (GEN1046) in advanced solid tumors Annals Of Oncology 2021, 32: s313. DOI: 10.1016/j.annonc.2021.05.625.
  • Abstract CT034: Activation of the antitumor immune response of gamma9delta2 T cells in patients with solid or hematologic malignancies with ICT01, a first-in-class, monoclonal antibody targeting butyrophilin 3A: The EVICTION studyMarabelle A, Jungels C, De Bono J, Vey N, Wermke M, Garralda E, Gouill S, LoRusso P, De Gassart A, Valentin E, Brune P, Iche M, Olive D, Frohna P. Abstract CT034: Activation of the antitumor immune response of gamma9delta2 T cells in patients with solid or hematologic malignancies with ICT01, a first-in-class, monoclonal antibody targeting butyrophilin 3A: The EVICTION study Cancer Research 2021, 81: ct034-ct034. DOI: 10.1158/1538-7445.am2021-ct034.
  • Abstract CT108: A first-in-human, Phase 1 study of ASTX029, a dual-mechanism inhibitor of ERK1/2, in relapsed/refractory solid tumorsLoRusso P, Rasco D, Shapiro G, Janku F, Mita A, Azad N, Toguchi M, Hindley C, Bradley S, Chan D, Keer H, Dao K, Sullivan R, Spira A. Abstract CT108: A first-in-human, Phase 1 study of ASTX029, a dual-mechanism inhibitor of ERK1/2, in relapsed/refractory solid tumors Cancer Research 2021, 81: ct108-ct108. DOI: 10.1158/1538-7445.am2021-ct108.
  • Abstract CT207: Phase 1 first-in-human study of ABBV-151 as monotherapy or in combination with budigalimab in patients with locally advanced or metastatic solid tumorsPowderly J, Shimizu T, LoRusso P, Razak A, Miller K, Balar A, Bruix J, Michel L, Blaney M, Guan X, Lacy S, Lally S, Lambert S, Leibman R, Vosganian G, Golan T, Tolcher A. Abstract CT207: Phase 1 first-in-human study of ABBV-151 as monotherapy or in combination with budigalimab in patients with locally advanced or metastatic solid tumors Cancer Research 2021, 81: ct207-ct207. DOI: 10.1158/1538-7445.am2021-ct207.
  • LBA-5 Phase Ib study of the anti-TIGIT antibody tiragolumab in combination with atezolizumab in patients with metastatic esophageal cancerWainberg Z, Matos I, Delord J, Cassier P, Gil-Martin M, Kim T, LoRusso P, Bahleda R, Italiano A, Mendus D, Hoang T, Xue C, Wen X, Carvalho O, Pham T, Patil N, Meng R, Bendell J, Cervantes A, Cho B. LBA-5 Phase Ib study of the anti-TIGIT antibody tiragolumab in combination with atezolizumab in patients with metastatic esophageal cancer Annals Of Oncology 2021, 32: s227-s228. DOI: 10.1016/j.annonc.2021.06.012.
  • SO-31 ASPEN-01: A phase 1 study of ALX148, a CD47 blocker, in combination with trastuzumab, ramucirumab and paclitaxel in patients with second-line HER2-positive advanced gastric or gastroesophageal junction cancerChung H, Lee K, Kim W, Gainor J, Lakhani N, Chow L, Messersmith W, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, LoRusso P. SO-31 ASPEN-01: A phase 1 study of ALX148, a CD47 blocker, in combination with trastuzumab, ramucirumab and paclitaxel in patients with second-line HER2-positive advanced gastric or gastroesophageal junction cancer Annals Of Oncology 2021, 32: s215-s216. DOI: 10.1016/j.annonc.2021.05.055.
  • Dynamics of circulating tumor DNA in patients with advanced solid tumors treated with cediranib and olaparib.Hu Y, Narayan A, Wolfe J, Vu D, Thi T, Kantak C, Ivy S, Eder J, LoRusso P, Kim J, Patel A. Dynamics of circulating tumor DNA in patients with advanced solid tumors treated with cediranib and olaparib. Journal Of Clinical Oncology 2021, 39: 3035-3035. DOI: 10.1200/jco.2021.39.15_suppl.3035.
  • Analysis of homologous recombination DNA repair gene mutation status in patients with metastatic small cell lung cancer treated with cediranib and olaparib on NCI 9881 study.Kim J, Radke M, Hafez N, Soliman H, Fu S, Kato S, Lara P, Vaishampayan U, Razak A, Cardin D, Munster P, Eder J, Shyr Y, Ivy S, LoRusso P, Swisher E. Analysis of homologous recombination DNA repair gene mutation status in patients with metastatic small cell lung cancer treated with cediranib and olaparib on NCI 9881 study. Journal Of Clinical Oncology 2021, 39: 8563-8563. DOI: 10.1200/jco.2021.39.15_suppl.8563.
  • A phase Ib study of xentuzumab plus abemaciclib and fulvestrant in patients (pts) with advanced hormone receptor-positive (HR+), HER2-negative breast cancer (BC) with visceral or non-visceral disease.Yee D, LoRusso P, Sablin M, Prat A, Stradella A, Utriainen M, Oliveira M, Yonemori K, Naito Y, Hardebeck M, Puig M, Hu J, Biyukov T, Iwata H. A phase Ib study of xentuzumab plus abemaciclib and fulvestrant in patients (pts) with advanced hormone receptor-positive (HR+), HER2-negative breast cancer (BC) with visceral or non-visceral disease. Journal Of Clinical Oncology 2021, 39: 1057-1057. DOI: 10.1200/jco.2021.39.15_suppl.1057.
  • A phase 1b, open-label, dose-escalation study to evaluate camidanlumab tesirine (Cami) as monotherapy in patients (pts) with advanced solid tumors.Puzanov I, LoRusso P, Papadopoulos K, Chen C, LeBruchec Y, He X, Cousin T, Havenith K, Boni J, Bendell J. A phase 1b, open-label, dose-escalation study to evaluate camidanlumab tesirine (Cami) as monotherapy in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2021, 39: 2556-2556. DOI: 10.1200/jco.2021.39.15_suppl.2556.
  • A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results.Tolcher A, Carneiro B, Dowlati A, Razak A, Chae Y, Villella J, Coppola S, Englert S, Phillips A, Souers A, Salman Z, Penugonda S, Powderly J, LoRusso P. A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results. Journal Of Clinical Oncology 2021, 39: 3015-3015. DOI: 10.1200/jco.2021.39.15_suppl.3015.
  • A phase I dose-escalation study of the MDM2-p53 antagonist BI 907828 in patients (pts) with advanced solid tumors.LoRusso P, Gounder M, Patel M, Yamamoto N, Bauer T, Laurie S, Grempler R, Davenport T, Geng J, Rohrbacher M, Lahmar M. A phase I dose-escalation study of the MDM2-p53 antagonist BI 907828 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2021, 39: 3016-3016. DOI: 10.1200/jco.2021.39.15_suppl.3016.
  • Phase 1 trial of a novel, first-in-class G protein-coupled estrogen receptor (GPER) agonist, LNS8801, in patients with advanced or recurrent treatment-refractory solid malignancies.Muller C, Brown-Glaberman U, Chaney M, Garyantes T, LoRusso P, McQuade J, Mita A, Mita M, Natale C, Orloff M, Papadopoulos K, Sato T, Yilmaz E, Rodon J. Phase 1 trial of a novel, first-in-class G protein-coupled estrogen receptor (GPER) agonist, LNS8801, in patients with advanced or recurrent treatment-refractory solid malignancies. Journal Of Clinical Oncology 2021, 39: 3084-3084. DOI: 10.1200/jco.2021.39.15_suppl.3084.
  • Safety and preliminary efficacy from the phase 1 portion of MasterKey-01: A First-in-human dose-escalation study to determine the recommended phase 2 dose (RP2D), pharmacokinetics (PK) and preliminary antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients (pts) with advanced solid malignancies.Schram A, Ahnert J, Patel M, Jauhari S, Sachdev J, Zhu V, LoRusso P, Nguyen D, Le X, O'Connor M, Waters N, Cook C, Witt K, Humphrey R, Janne P, Hamilton E. Safety and preliminary efficacy from the phase 1 portion of MasterKey-01: A First-in-human dose-escalation study to determine the recommended phase 2 dose (RP2D), pharmacokinetics (PK) and preliminary antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients (pts) with advanced solid malignancies. Journal Of Clinical Oncology 2021, 39: 3086-3086. DOI: 10.1200/jco.2021.39.15_suppl.3086.
  • Clinical pharmacokinetics of bdtx-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies in MasterKey-01 study.Waters N, Patel M, Schram A, Ahnert J, Jauhari S, Sachdev J, Zhu V, LoRusso P, Nguyen D, Hong D, Tarilonte L, Humphrey R, Janne P, Hamilton E, Witt K. Clinical pharmacokinetics of bdtx-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies in MasterKey-01 study. Journal Of Clinical Oncology 2021, 39: 3097-3097. DOI: 10.1200/jco.2021.39.15_suppl.3097.
  • Safety and efficacy of the anti-CD73 monoclonal antibody (mAb) oleclumab ± durvalumab in patients (pts) with advanced colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), or EGFR-mutant non-small cell lung cancer (EGFRm NSCLC).Bendell J, LoRusso P, Overman M, Noonan A, Kim D, Strickler J, Kim S, Clarke S, George T, Grimison P, Barve M, Amin M, Desai J, Wise-Draper T, Cooper Z, Elgeioushi N, Mueller N, Kumar R, Wu K, Patel S. Safety and efficacy of the anti-CD73 monoclonal antibody (mAb) oleclumab ± durvalumab in patients (pts) with advanced colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), or EGFR-mutant non-small cell lung cancer (EGFRm NSCLC). Journal Of Clinical Oncology 2021, 39: 9047-9047. DOI: 10.1200/jco.2021.39.15_suppl.9047.
  • A phase 1 dose-escalation study of intravenously (IV) administered TAK-676, a novel STING agonist, alone and in combination with pembrolizumab in patients (pts) with advanced or metastatic solid tumors.Falchook G, Luke J, Strauss J, Gao X, LoRusso P, VOON P, Li C, Shaw M, Gregory R, Horn K, Gibbs J, Lineberry N, Stumpo K, Malek K, Olszanski A. A phase 1 dose-escalation study of intravenously (IV) administered TAK-676, a novel STING agonist, alone and in combination with pembrolizumab in patients (pts) with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2021, 39: tps2670-tps2670. DOI: 10.1200/jco.2021.39.15_suppl.tps2670.
  • Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC).Kim J, Milowsky M, Hahn N, Kwiatkowski D, Morgans A, Davis N, Appleman L, Gupta S, Lara P, Hoffman-Censits J, Quinn D, Shyr Y, LoRusso P, Sklar J, Petrylak D. Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2021, 39: 431-431. DOI: 10.1200/jco.2021.39.6_suppl.431.
  • Biomarker analysis from a randomized phase II study of olaparib with or without cediranib in men with metastatic castration-resistant prostate cancer (mCRPC).McKay R, McKay R, Radke M, Radke M, Shyr Y, Shyr Y, Zhao S, Zhao S, Taplin M, Taplin M, Davis N, Davis N, Monk P, Monk P, Appleman L, Appleman L, Lara P, Lara P, Vaishampayan U, Vaishampayan U, Zhang J, Zhang J, Paul A, Paul A, Bubley G, Bubley G, Huang Y, Huang Y, Shapiro G, Shapiro G, LoRusso P, Ivy S, Ivy S, Petrylak D, Swisher E, Swisher E, Kim J. Biomarker analysis from a randomized phase II study of olaparib with or without cediranib in men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2021, 39: 7-7. DOI: 10.1200/jco.2021.39.6_suppl.7.
  • A phase I/II study of combination olaparib and radium-223 in men with metastatic castration-resistant prostate cancer with bone metastases (COMRADE): A trial in progress.Shaya J, Xie W, Saraiya B, Parikh M, Folefac E, Olson A, Choudhury A, Einstein D, Heath E, Parikh R, Kunos C, Ivy S, LoRusso P, Kurzrock R, Shapiro G, McKay R. A phase I/II study of combination olaparib and radium-223 in men with metastatic castration-resistant prostate cancer with bone metastases (COMRADE): A trial in progress. Journal Of Clinical Oncology 2021, 39: tps182-tps182. DOI: 10.1200/jco.2021.39.6_suppl.tps182.
  • Abstract PS11-07: Intratumoral activation and phase 1/2 clinical activity of CX-2009, a probody drug conjugate (PDC) targeting CD166Liu J, Zein I, Dang T, Lyman S, Spira A, Uboha N, LoRusso P, Fidler M, Meric-Bernstam F, Arkenau T, Nagasaka M, Desnoyers L, Kavanaugh W, Paton V, Hannah A, Boni V. Abstract PS11-07: Intratumoral activation and phase 1/2 clinical activity of CX-2009, a probody drug conjugate (PDC) targeting CD166 Cancer Research 2021, 81: ps11-07-ps11-07. DOI: 10.1158/1538-7445.sabcs20-ps11-07.
  • 395 A first-in-human study of FS118, a tetravalent bispecific antibody targeting LAG-3 and PD-L1, in patients with advanced cancer and resistance to PD-(L)1 therapyYap T, Wong D, Hu-Lieskovan S, Papadopoulos K, Morrow M, Grabowska U, Gliddon D, Holz J, LoRusso P. 395 A first-in-human study of FS118, a tetravalent bispecific antibody targeting LAG-3 and PD-L1, in patients with advanced cancer and resistance to PD-(L)1 therapy 2020, a240-a240. DOI: 10.1136/jitc-2020-sitc2020.0395.
  • 807 A multicenter open-label phase I/lb study of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumorsMarabelle A, Champiat S, Garralda E, Hernando A, Janku F, Raina A, Sachse R, Bechard D, Krasnopolskaya I, Ferrara S, LoRusso P. 807 A multicenter open-label phase I/lb study of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors 2020, a483.1-a483. DOI: 10.1136/jitc-2020-sitc2020.0807.
  • 412 First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody®-PD-L1×4–1BB (GEN1046) in patients with advanced solid tumorsGarralda E, Geva R, Ben-Ami E, Maurice-Dror C, Calvo E, LoRusso P, Türeci Ö, Niewood M, Şahin U, Jure-Kunkel M, Forssmann U, Ahmadi T, Melero I. 412 First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody®-PD-L1×4–1BB (GEN1046) in patients with advanced solid tumors Journal For ImmunoTherapy Of Cancer 2020, 8: a250-a251. DOI: 10.1136/jitc-2020-sitc2020.0412.
  • 404 ALX148, a CD47 blocker, in combination with standard chemotherapy and antibody regimens in patients with gastric/gastroesophageal junction (GC) cancer and head and neck squamous cell carcinoma (HNSCC)Lee K, Chung H, Kim W, Chow L, Lakhani N, Messersmith W, Bang Y, LoRusso P, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, Gainor J. 404 ALX148, a CD47 blocker, in combination with standard chemotherapy and antibody regimens in patients with gastric/gastroesophageal junction (GC) cancer and head and neck squamous cell carcinoma (HNSCC) 2020, a245.2-a246. DOI: 10.1136/jitc-2020-sitc2020.0404.
  • 7LBA Late Breaking Milademetan, an oral MDM2 inhibitor, in well-differentiated/ dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomasGounder M, Bauer T, Schwartz G, LoRusso P, Kumar P, Kato K, Tao B, Hong Y, Patel P, Hong D. 7LBA Late Breaking Milademetan, an oral MDM2 inhibitor, in well-differentiated/ dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomas European Journal Of Cancer 2020, 138: s3-s4. DOI: 10.1016/s0959-8049(20)31080-7.
  • Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic CenterHong D, Marcelo-Lewis K, LoRusso P. Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center 2020, 71-83. DOI: 10.1007/978-3-030-47682-3_4.
  • Phase I first-in-human study of ABBV-151 as monotherapy or in combination with budigalimab in patients with locally advanced or metastatic solid tumoursPowderly J, Shimizu T, Lorusso P, Razak A, Miller K, Balar A, Bruix J, Michel L, Blaney M, Guan X, Lacy S, Lally S, Lambert S, Leibman R, Vosganian G, Golan T, Tolcher A. Phase I first-in-human study of ABBV-151 as monotherapy or in combination with budigalimab in patients with locally advanced or metastatic solid tumours Annals Of Oncology 2020, 31: s499. DOI: 10.1016/j.annonc.2020.08.710.
  • Phase Ib study of ribociclib (R) + trametinib (T) in patients (pts) with metastatic/advanced solid tumoursLoRusso P, Fakih M, De Vos F, Beck J, Merchan J, Shapiro G, Lin C, Desai J, Spratlin J, Cascella T, Sandalic L, Abdelhady A, Boran A, Gasal E, Janku F, Van Cutsem E. Phase Ib study of ribociclib (R) + trametinib (T) in patients (pts) with metastatic/advanced solid tumours Annals Of Oncology 2020, 31: s484. DOI: 10.1016/j.annonc.2020.08.675.
  • First-in-human study of camidanlumab tesirine (ADCT-301, Cami), an anti-CD25 targeted therapy in patients (pts) with advanced solid tumours: Pharmacokinetics (PK) and biomarker evaluationPuzanov I, Havenith K, Boni J, Cruz H, Anderson K, Kopotsha T, Le Bruchec Y, Bendell J, Kummar S, Papadopoulos K, LoRusso P, Wuerthner J. First-in-human study of camidanlumab tesirine (ADCT-301, Cami), an anti-CD25 targeted therapy in patients (pts) with advanced solid tumours: Pharmacokinetics (PK) and biomarker evaluation Annals Of Oncology 2020, 31: s710-s711. DOI: 10.1016/j.annonc.2020.08.1150.
  • A multicenter, open-label, dose-escalation, first-in-man study of MetAP2 inhibitor M8891 in patients with advanced solid tumoursCarducci M, Wang D, Habermehl C, Bödding M, Rohdich F, Stinchi S, Karpenko O, Gimmi C, LoRusso P. A multicenter, open-label, dose-escalation, first-in-man study of MetAP2 inhibitor M8891 in patients with advanced solid tumours Annals Of Oncology 2020, 31: s486. DOI: 10.1016/j.annonc.2020.08.680.
  • Updated results of a phase I study of Felezonexor (SL-801), a novel XPO-1 reversible inhibitor, in patients with relapsed/refractory solid tumoursWang J, Barve M, Chiorean E, LoRusso P, Courtney K, Qi D, Bullington J, Sardone M, Chen J, Brooks C, Hoberman M, Mughal T, Bauer T. Updated results of a phase I study of Felezonexor (SL-801), a novel XPO-1 reversible inhibitor, in patients with relapsed/refractory solid tumours Annals Of Oncology 2020, 31: s485-s486. DOI: 10.1016/j.annonc.2020.08.678.
  • Abstract CT165: An open label, multi-cohort, phase Ib study of xentuzumab and abemaciclib: Preliminary results from the advanced non-small cell lung cancer (NSCLC) cohortLoRusso P, García-Corbacho J, Braiteh F, Gonçalves A, Ricci F, Iwata H, Capelán M, Sablin M, Prat A, Hardebeck M, Puig M, Huang D, Hsu M, Yee D. Abstract CT165: An open label, multi-cohort, phase Ib study of xentuzumab and abemaciclib: Preliminary results from the advanced non-small cell lung cancer (NSCLC) cohort Cancer Research 2020, 80: ct165-ct165. DOI: 10.1158/1538-7445.am2020-ct165.
  • Abstract CT169: A phase Ia study to evaluate RO7198457, an individualized Neoantigen Specific immunoTherapy (iNeST), in patients with locally advanced or metastatic solid tumorsBraiteh F, LoRusso P, Balmanoukian A, Klempner S, Camidge D, Hellmann M, Gordon M, Bendell J, Mueller L, Sabado R, Twomey P, Delamarre L, Huang J, Yadav M, Zhang J, McDonald P, Müller F, Derhovanessian E, Türeci Ö, Sahin U, Siu L. Abstract CT169: A phase Ia study to evaluate RO7198457, an individualized Neoantigen Specific immunoTherapy (iNeST), in patients with locally advanced or metastatic solid tumors Cancer Research 2020, 80: ct169-ct169. DOI: 10.1158/1538-7445.am2020-ct169.
  • Preliminary efficacy data of triple-negative breast cancer cohort of NCI 9881 study: A phase II study of cediranib in combination with olaparib in advanced solid tumors.Hafez N, Soliman H, Fu S, Gelmon K, Abdul Razak A, Munster P, Vaishampayan U, Kato S, Lara P, Swisher E, Nixon A, Patel A, Shyr Y, Ivy S, LoRusso P, Kim J. Preliminary efficacy data of triple-negative breast cancer cohort of NCI 9881 study: A phase II study of cediranib in combination with olaparib in advanced solid tumors. Journal Of Clinical Oncology 2020, 38: 1077-1077. DOI: 10.1200/jco.2020.38.15_suppl.1077.
  • Preliminary efficacy data of platinum-pretreated small cell lung cancer (SCLC) cohort of NCI 9881 study: A phase II study of cediranib in combination with olaparib in advanced solid tumors.Kim J, Hafez N, Soliman H, Fu S, Kato S, Lara P, Vaishampayan U, Abdul Razak A, Cardin D, Munster P, Eder J, Swisher E, Nixon A, Patel A, Shyr Y, Ivy S, LoRusso P. Preliminary efficacy data of platinum-pretreated small cell lung cancer (SCLC) cohort of NCI 9881 study: A phase II study of cediranib in combination with olaparib in advanced solid tumors. Journal Of Clinical Oncology 2020, 38: 9065-9065. DOI: 10.1200/jco.2020.38.15_suppl.9065.
  • Trial in progress: A phase I/II, open-label, dose-escalation, safety and tolerability study of NC318 in subjects with advanced or metastatic solid tumors.Gutierrez M, Hamid O, Shum E, Wise D, Balar A, Weber J, LoRusso P, Shafi S, Rimm D, Tolcher A, Basudhar D, Dujka M, Heller K. Trial in progress: A phase I/II, open-label, dose-escalation, safety and tolerability study of NC318 in subjects with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2020, 38: tps3166-tps3166. DOI: 10.1200/jco.2020.38.15_suppl.tps3166.
  • Trial in progress: A phase II open-label, randomized study of PARP inhibition (olaparib) either alone or in combination with anti-PD-L1 therapy (atezolizumab) in homologous DNA repair (HDR) deficient, locally advanced or metastatic non-HER2-positive breast cancer.LoRusso P, Pilat M, Santa-Maria C, Connolly R, Roesch E, Afghahi A, Han H, Nanda R, Wulf G, Assad H, Park H, Dees E, Force J, Noonan A, Brufsky A, Abramson V, Haley B, Buys S, Sharon E, Schalper K. Trial in progress: A phase II open-label, randomized study of PARP inhibition (olaparib) either alone or in combination with anti-PD-L1 therapy (atezolizumab) in homologous DNA repair (HDR) deficient, locally advanced or metastatic non-HER2-positive breast cancer. Journal Of Clinical Oncology 2020, 38: tps1102-tps1102. DOI: 10.1200/jco.2020.38.15_suppl.tps1102.
  • PROCLAIM-CX-072: Analysis of patients with advanced solid tumors receiving long-term treatment with CX-072, a PD-L1 probody therapeutic, as a single agent or in combination with ipilimumab.Thistlethwaite F, Naing A, Gil-Martin M, LoRusso P, Randhawa M, Eskens F, Sanborn R, Uboha N, Cho D, Spira A, Bondarenko I, Plummer E, Garcia-Corbacho J, Victoria I, Lavernia J, Melero I, De Vries E, Garner W, Arkenau H, Bendell J. PROCLAIM-CX-072: Analysis of patients with advanced solid tumors receiving long-term treatment with CX-072, a PD-L1 probody therapeutic, as a single agent or in combination with ipilimumab. Journal Of Clinical Oncology 2020, 38: 3005-3005. DOI: 10.1200/jco.2020.38.15_suppl.3005.
  • A phase I study of ALX148, a CD47 blocker, in combination with standard anticancer antibodies and chemotherapy regimens in patients with advanced malignancy.Chow L, Gainor J, Lakhani N, Lee K, Chung H, Lee J, LoRusso P, Bang Y, Hodi F, Santana-Davila R, Fanning P, Squifflet P, Jin F, Wan H, Kuo T, Pons J, Randolph S, Messersmith W. A phase I study of ALX148, a CD47 blocker, in combination with standard anticancer antibodies and chemotherapy regimens in patients with advanced malignancy. Journal Of Clinical Oncology 2020, 38: 3056-3056. DOI: 10.1200/jco.2020.38.15_suppl.3056.
  • A phase I study of mRNA-2752, a lipid nanoparticle encapsulating mRNAs encoding human OX40L, IL-23, and IL-36γ, for intratumoral (iTu) injection alone and in combination with durvalumab.Patel M, Bauer T, Jimeno A, Wang D, LoRusso P, Do K, Stemmer S, Maurice-Dror C, Geva R, Zacharek S, Laino A, Sun J, Frederick J, Zhou H, Randolph W, Cohen P, Meehan R, Sullivan R. A phase I study of mRNA-2752, a lipid nanoparticle encapsulating mRNAs encoding human OX40L, IL-23, and IL-36γ, for intratumoral (iTu) injection alone and in combination with durvalumab. Journal Of Clinical Oncology 2020, 38: 3092-3092. DOI: 10.1200/jco.2020.38.15_suppl.3092.
  • CX-2009, a CD166-directed probody drug conjugate (PDC): Results from the first-in-human study in patients (Pts) with advanced cancer including breast cancer (BC).Boni V, Burris III H, Liu J, Spira A, Arkenau H, Fidler M, Rosen L, Sweis R, Uboha N, Sanborn R, O'Neil B, Harding J, LoRusso P, Weise A, Garcia-Corbacho J, Victoria I, Frye J, Li R, Stroh M, Meric-Bernstam F. CX-2009, a CD166-directed probody drug conjugate (PDC): Results from the first-in-human study in patients (Pts) with advanced cancer including breast cancer (BC). Journal Of Clinical Oncology 2020, 38: 526-526. DOI: 10.1200/jco.2020.38.15_suppl.526.
  • Pharmacodynamic effects in blood and tumor tissue of eftozanermin alfa, a tumor necrosis factor-related apoptosis-inducing ligand receptor agonist.Motwani M, Modi D, Penugonda S, Zhang C, Palma J, Cunningham A, Calvo E, de Jonge M, LoRusso P. Pharmacodynamic effects in blood and tumor tissue of eftozanermin alfa, a tumor necrosis factor-related apoptosis-inducing ligand receptor agonist. Journal Of Clinical Oncology 2020, 38: e15668-e15668. DOI: 10.1200/jco.2020.38.15_suppl.e15668.
  • A phase I study of CD40 agonist ABBV-927 plus OX40 agonist ABBV-368 with or without the PD-1 inhibitor budigalimab in patients with advanced solid tumors.Powderly J, Tolcher A, LoRusso P, Blaney M, Dacosta D, Henner W, McDevitt M, Miller K, Golan T. A phase I study of CD40 agonist ABBV-927 plus OX40 agonist ABBV-368 with or without the PD-1 inhibitor budigalimab in patients with advanced solid tumors. Journal Of Clinical Oncology 2020, 38: tps3147-tps3147. DOI: 10.1200/jco.2020.38.15_suppl.tps3147.
  • Phase I/II dose-escalation and expansion study of FLX475 alone and in combination with pembrolizumab in advanced cancer.Powderly J, Chmielowski B, Brahmer J, Piha-Paul S, Bowyer S, LoRusso P, Catenacci D, Wu C, Barve M, Chisamore M, Nasrah N, Johnson D, Ho W. Phase I/II dose-escalation and expansion study of FLX475 alone and in combination with pembrolizumab in advanced cancer. Journal Of Clinical Oncology 2020, 38: tps3163-tps3163. DOI: 10.1200/jco.2020.38.15_suppl.tps3163.
  • Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies.Hamilton E, Patel M, Rodon J, Hong D, Schram A, Janne P, LoRusso P, Sachdev J, Ou S, Buck E, O'Connor M, Waters N, Witt K, Cook C. Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies. Journal Of Clinical Oncology 2020, 38: tps3665-tps3665. DOI: 10.1200/jco.2020.38.15_suppl.tps3665.
  • Randomized phase II study of olaparib with or without cediranib in men with metastatic castration-resistant prostate cancer (mCRPC).Kim J, McKay R, McKay R, Taplin M, Taplin M, Davis N, Davis N, Monk P, Monk P, Appleman L, Appleman L, Lara P, Lara P, Vaishampayan U, Vaishampayan U, Zhang J, Zhang J, Paul A, Paul A, Bubley G, Bubley G, Van Allen E, Van Allen E, Huang Y, Huang Y, Zhang Z, Zhang Z, Loda M, Loda M, Shapiro G, Shapiro G, LoRusso P, Ivy S, Ivy S, Petrylak D. Randomized phase II study of olaparib with or without cediranib in men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2020, 38: 111-111. DOI: 10.1200/jco.2020.38.6_suppl.111.
  • Abstract P3-11-05: A phase Ib multi-cohort study of xentuzumab and abemaciclib in patients (pts) with solid tumors and breast cancer (BC) - Initial report of four dose-finding cohortsYee D, Oliveira M, Iwata H, Gonçalves A, García-Corbacho J, Sablin M, Prat A, Hardebeck M, Puig M, Huang D, Hsu M, LoRusso P. Abstract P3-11-05: A phase Ib multi-cohort study of xentuzumab and abemaciclib in patients (pts) with solid tumors and breast cancer (BC) - Initial report of four dose-finding cohorts Cancer Research 2020, 80: p3-11-05-p3-11-05. DOI: 10.1158/1538-7445.sabcs19-p3-11-05.
  • Abstract P5-04-06: Reprogramming the suppressive tumor microenvironment of breast cancerTorres E, Kagohara L, Davis E, Rafie C, Christmas B, Zhu Q, Wang C, Lim D, Anders R, Fertig E, Chung V, Lorusso P, Brufsky A, Jaffee E, Stearns V, Connolly R. Abstract P5-04-06: Reprogramming the suppressive tumor microenvironment of breast cancer Cancer Research 2020, 80: p5-04-06-p5-04-06. DOI: 10.1158/1538-7445.sabcs19-p5-04-06.
  • Abstract P5-11-01 : Phase 1 dose escalation study of a novel selective androgen receptor modulator (SARM), RAD140, in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancerHamilton E, LoRusso P, Ma C, Vidula N, Bagley R, Troy S, Annett M, Yu Z, Weitzman A, Conlan M, Weise A. Abstract P5-11-01 : Phase 1 dose escalation study of a novel selective androgen receptor modulator (SARM), RAD140, in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer Cancer Research 2020, 80: p5-11-01-p5-11-01. DOI: 10.1158/1538-7445.sabcs19-p5-11-01.
  • Association of an RNA signature (RS) with emergence of ICOS hi CD4 T cells and efficacy outcomes for the ICOS agonist vopratelimab (vopra) and nivolumab (nivo) in patients (pts) on the ICONIC trial.Yap T, Gainor J, Burris H, Kummar S, Pachynski R, Callahan M, LoRusso P, Tykodi S, Gibney G, Falchook G, Rahma O, Seiwert T, Papadopoulos K, Mier J, Hashambhoy-Ramsay Y, Felitsky D, Lee D, McGrath L, Harvey C, Hooper E. Association of an RNA signature (RS) with emergence of ICOS hi CD4 T cells and efficacy outcomes for the ICOS agonist vopratelimab (vopra) and nivolumab (nivo) in patients (pts) on the ICONIC trial. Journal Of Clinical Oncology 2020, 38: 14-14. DOI: 10.1200/jco.2020.38.5_suppl.14.
  • Abstract C025: HexaBody-DR5/DR5 (GEN1029) shows potent preclinical antitumor activity in a variety of patient-derived xenograft (PDX) tumor modelsOverdijk M, Cecchini M, Strumane K, Brandhorst M, Lingnau A, Parren P, Ellekilde-Pedersen M, Forssmann U, Ahmadi T, Sasser A, Schuurman J, Breij E, LoRusso P. Abstract C025: HexaBody-DR5/DR5 (GEN1029) shows potent preclinical antitumor activity in a variety of patient-derived xenograft (PDX) tumor models Molecular Cancer Therapeutics 2019, 18: c025-c025. DOI: 10.1158/1535-7163.targ-19-c025.
  • Abstract A080: Olaparib and the ATR inhibitor AZD6738 in relapsed, refractory cancer patients with homologous recombination (HR) repair mutations – OLAPCOEder J, Sohal D, Mahdi H, Do K, Keedy V, Hafez N, Doroshow D, Avedissian M, Mortimer P, Glover C, LoRusso P, Juergensmeier J, Shapiro G. Abstract A080: Olaparib and the ATR inhibitor AZD6738 in relapsed, refractory cancer patients with homologous recombination (HR) repair mutations – OLAPCO Molecular Cancer Therapeutics 2019, 18: a080-a080. DOI: 10.1158/1535-7163.targ-19-a080.
  • 343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC)Hamilton E, Vidula N, Ma C, LoRusso P, Bagley R, Yu Z, Annett M, Weitzman A, Conlan M, Weise A. 343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC) Annals Of Oncology 2019, 30: v123. DOI: 10.1093/annonc/mdz242.038.
  • 466P Interim results from trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumoursWang J, Barve M, Chiorean E, LoRusso P, Courtney K, Qi D, Bullington J, Sardone M, Chen J, Brooks C, Shemesh S, Bauer T. 466P Interim results from trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumours Annals Of Oncology 2019, 30: v175. DOI: 10.1093/annonc/mdz244.028.
  • 457P First-in-human study of ABBV-621 in patients (pts) with previously treated sold tumours: Dose-optimization cohortsCalvo E, de Jonge M, Rasco D, Moreno V, Chang Y, Chiney M, Motwani M, Penugonda S, Petrich A, Ratain M, LoRusso P. 457P First-in-human study of ABBV-621 in patients (pts) with previously treated sold tumours: Dose-optimization cohorts Annals Of Oncology 2019, 30: v169-v170. DOI: 10.1093/annonc/mdz244.019.
  • 1198P FPA150 (B7-H4 antibody) phase I update in advanced solid tumours: Monotherapy and in combination with pembrolizumabWainberg Z, Sachdev J, Bauer T, Pant S, Chawla S, Marina N, Xiang H, Deng W, Schmidt M, Patnaik A, LoRusso P. 1198P FPA150 (B7-H4 antibody) phase I update in advanced solid tumours: Monotherapy and in combination with pembrolizumab Annals Of Oncology 2019, 30: v489. DOI: 10.1093/annonc/mdz253.024.
  • Abstract CT189: Improved progression-free and overall survival (PFS/OS) in patients (pts) with emergence of JTX-2011 associated biomarker (ICOS high CD4 T cells) on the ICONIC trialYap T, Gainor J, Callahan M, Falchook G, Pachynski R, LoRusso P, Kummar S, Gibney G, Burris H, Tykodi S, Rahma O, Seiwert T, Papadopoulos K, Hooper E, Harvey C, Hanson A, Lacey S, McComb R, Hart C, Laken H, McClure T, Trehu E. Abstract CT189: Improved progression-free and overall survival (PFS/OS) in patients (pts) with emergence of JTX-2011 associated biomarker (ICOS high CD4 T cells) on the ICONIC trial 2019, ct189-ct189. DOI: 10.1158/1538-7445.sabcs18-ct189.
  • Abstract CT189: Improved progression-free and overall survival (PFS/OS) in patients (pts) with emergence of JTX-2011 associated biomarker (ICOS high CD4 T cells) on the ICONIC trialYap T, Gainor J, Callahan M, Falchook G, Pachynski R, LoRusso P, Kummar S, Gibney G, Burris H, Tykodi S, Rahma O, Seiwert T, Papadopoulos K, Hooper E, Harvey C, Hanson A, Lacey S, McComb R, Hart C, Laken H, McClure T, Trehu E. Abstract CT189: Improved progression-free and overall survival (PFS/OS) in patients (pts) with emergence of JTX-2011 associated biomarker (ICOS high CD4 T cells) on the ICONIC trial Cancer Research 2019, 79: ct189-ct189. DOI: 10.1158/1538-7445.am2019-ct189.
  • CX-072, a PD-L1 Probody therapeutic, as monotherapy in patients with advanced solid tumors: Preliminary results of PROCLAIM-CX-072.Naing A, Thistlethwaite F, Spira A, Garcia-Corbacho J, Randhawa M, Eskens F, O'Neil B, Lavernia J, Uboha N, Hamid O, El-Khoueiry A, Benson B, Garner W, Huels V, Arkenau H, LoRusso P. CX-072, a PD-L1 Probody therapeutic, as monotherapy in patients with advanced solid tumors: Preliminary results of PROCLAIM-CX-072. Journal Of Clinical Oncology 2019, 37: 2513-2513. DOI: 10.1200/jco.2019.37.15_suppl.2513.
  • A phase I study of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy.Chow L, Gainor J, Lakhani N, Chung H, Lee K, Lee J, LoRusso P, Bang Y, Hodi F, Fanning P, Zhao Y, Jin F, Wan H, Pons J, Randolph S, Messersmith W. A phase I study of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy. Journal Of Clinical Oncology 2019, 37: 2514-2514. DOI: 10.1200/jco.2019.37.15_suppl.2514.
  • Phase 1a/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors.Sachdev J, Bauer T, Chawla S, Pant S, Patnaik A, Wainberg Z, Inamdar S, Marina N, Sun S, Schmidt M, Xiang H, LoRusso P. Phase 1a/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors. Journal Of Clinical Oncology 2019, 37: 2529-2529. DOI: 10.1200/jco.2019.37.15_suppl.2529.
  • Phase 1, first-in-human study of TRAIL receptor agonist fusion protein ABBV-621.Ratain M, Doi T, De Jonge M, LoRusso P, Dunbar M, Chiney M, Motwani M, Glasgow J, Petrich A, Rasco D, Calvo E. Phase 1, first-in-human study of TRAIL receptor agonist fusion protein ABBV-621. Journal Of Clinical Oncology 2019, 37: 3013-3013. DOI: 10.1200/jco.2019.37.15_suppl.3013.
  • A phase I/Ib multicenter study to evaluate the humanized anti-CD73 antibody, CPI-006, as a single agent, in combination with CPI-444, and in combination with pembrolizumab in adult patients with advanced cancers.Mobasher M, Miller R, Kwei L, Strahs D, Das V, Luciano G, Powderly J, Merchan J, Barve M, LoRusso P, Tripathi A, Luke J. A phase I/Ib multicenter study to evaluate the humanized anti-CD73 antibody, CPI-006, as a single agent, in combination with CPI-444, and in combination with pembrolizumab in adult patients with advanced cancers. Journal Of Clinical Oncology 2019, 37: tps2646-tps2646. DOI: 10.1200/jco.2019.37.15_suppl.tps2646.
  • A first-in-human phase I study of FS118, an anti-LAG-3/PD-L1 bispecific antibody in patients with solid tumors that have progressed on prior PD-1/PD-L1 therapy.Yap T, Papadopoulos K, LoRusso P, Wong D, Hu-Lieskovan S, Holz J. A first-in-human phase I study of FS118, an anti-LAG-3/PD-L1 bispecific antibody in patients with solid tumors that have progressed on prior PD-1/PD-L1 therapy. Journal Of Clinical Oncology 2019, 37: tps2652-tps2652. DOI: 10.1200/jco.2019.37.15_suppl.tps2652.
  • A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 (MDM2-p53 antagonist) in adult patients with advanced or metastatic solid tumors.Chong C, Bauer T, Laurie S, Patel M, Yamamoto N, Davenport T, Geng J, Gibson N, Vallaster M, LoRusso P. A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 (MDM2-p53 antagonist) in adult patients with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2019, 37: tps3166-tps3166. DOI: 10.1200/jco.2019.37.15_suppl.tps3166.
  • Abstract OT1-02-02: A phase 1, first-in-human, multi-part study of RAD140, an oral nonsteroidal selective androgen receptor modulator, in postmenopausal women with hormone receptor positive breast cancerHamilton E, Vidula N, Ma C, LoRusso P, Saeh J, Reichert V, Yu Z, Annett M, Weitzman A, Hattersly G, O'Neill A, Weise A. Abstract OT1-02-02: A phase 1, first-in-human, multi-part study of RAD140, an oral nonsteroidal selective androgen receptor modulator, in postmenopausal women with hormone receptor positive breast cancer Cancer Research 2019, 79: ot1-02-02-ot1-02-02. DOI: 10.1158/1538-7445.sabcs18-ot1-02-02.
  • Abstract P6-18-31: PROCLAIM-CX-072: Monotherapy for advanced triple negative breast cancer with skin metastases in a phase 1-2 trial of the PD-L1 probody therapeutic CX-072Adams S, Hamilton E, Ott P, Cho D, Kalinsky K, LoRusso P, Will M, Huels V, Benson B, Murias C, Arkenau H. Abstract P6-18-31: PROCLAIM-CX-072: Monotherapy for advanced triple negative breast cancer with skin metastases in a phase 1-2 trial of the PD-L1 probody therapeutic CX-072 Cancer Research 2019, 79: p6-18-31-p6-18-31. DOI: 10.1158/1538-7445.sabcs18-p6-18-31.
  • 422P First-in-human study of the monopolar spindle 1 (Mps1) kinase inhibitor BAY 1161909 in combination with paclitaxel in subjects with advanced malignanciesLorusso P, Chawla S, Bendell J, Shields A, Shapiro G, Rajagopalan P, Cyris C, Bruns I, Mei J, Souza F, Rasco D, Eder J, Tolcher A. 422P First-in-human study of the monopolar spindle 1 (Mps1) kinase inhibitor BAY 1161909 in combination with paclitaxel in subjects with advanced malignancies Annals Of Oncology 2018, 29: viii138. DOI: 10.1093/annonc/mdy279.410.
  • 428P Interim results from a phase I trial of SL-801: A novel XPO-1 inhibitor, in patients with advanced solid tumorsBauer T, Barve M, Chiorean E, Lorusso P, Courtney K, Qi D, Olguin A, Bullington J, Sardone M, Dunn V, Shemesh S, Chen J, Brooks C, Wang J. 428P Interim results from a phase I trial of SL-801: A novel XPO-1 inhibitor, in patients with advanced solid tumors Annals Of Oncology 2018, 29: viii140. DOI: 10.1093/annonc/mdy279.415.
  • 436P Preliminary results of the first-in-human, dose-finding PROCLAIM-CX-072 trial evaluating the PD-L1 probody therapeutic CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumorsPlummer R, Sanborn R, de Vries E, Lorusso P, Arkenau H, Uboha N, Wydmanski J, Fidler M, Boni V, Garcia-Corbacho J, Humphrey R, Will M, Autio K, El-Khoueiry A, van Oordt C, Thistlethwaite F. 436P Preliminary results of the first-in-human, dose-finding PROCLAIM-CX-072 trial evaluating the PD-L1 probody therapeutic CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors Annals Of Oncology 2018, 29: viii143. DOI: 10.1093/annonc/mdy279.423.
  • Abstract CT012: Phase I study of TAS-114 in combination with capecitabine in patients with advanced solid tumorsLoRusso P, Miller K, Shields A, Chung K, Yoshisue K, Aoyama T, Lenz H. Abstract CT012: Phase I study of TAS-114 in combination with capecitabine in patients with advanced solid tumors Cancer Research 2018, 78: ct012-ct012. DOI: 10.1158/1538-7445.am2018-ct012.
  • NCI 10066: A phase 1 / 2 study of olaparib in combination with ramucirumab in metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma.Cecchini M, LoRusso P, Shyr Y, Ivy S, Sklar J, Dooley K, Lacy J. NCI 10066: A phase 1 / 2 study of olaparib in combination with ramucirumab in metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Journal Of Clinical Oncology 2018, 36: tps4137-tps4137. DOI: 10.1200/jco.2018.36.15_suppl.tps4137.
  • A phase 1 study of MDM2 inhibitor DS-3032b in patients with well/de-differentiated liposarcoma (WD/DD LPS), solid tumors (ST) and lymphomas (L).Bauer T, Gounder M, Weise A, Schwartz G, Carvajal R, Kumar P, Zernovak O, Beck A, Doyle J, Mendell-Harary J, Kochan J, Chen S, LoRusso P, Tap W, Somaiah N, Hyman D, Meric-Bernstam F, Hong D. A phase 1 study of MDM2 inhibitor DS-3032b in patients with well/de-differentiated liposarcoma (WD/DD LPS), solid tumors (ST) and lymphomas (L). Journal Of Clinical Oncology 2018, 36: 11514-11514. DOI: 10.1200/jco.2018.36.15_suppl.11514.
  • Results of the first-in-human study of ABBV-075 (mivebresib), a pan-inhibitor of bromodomain (BD) and extra terminal (BET) proteins, in patients (pts) with relapsed/refractory (R/R) solid tumors.Piha-Paul S, Sachdev J, Barve M, LoRusso P, Szmulewitz R, Patel S, McKee M, Wolff J, Hu B, Sood A, Chen X, Wilson S, O'Neil B. Results of the first-in-human study of ABBV-075 (mivebresib), a pan-inhibitor of bromodomain (BD) and extra terminal (BET) proteins, in patients (pts) with relapsed/refractory (R/R) solid tumors. Journal Of Clinical Oncology 2018, 36: 2510-2510. DOI: 10.1200/jco.2018.36.15_suppl.2510.
  • A phase I study of AL101, a pan-NOTCH inhibitor, in patients (pts) with locally advanced or metastatic solid tumors.El-Khoueiry A, Desai J, Iyer S, Gadgeel S, Ramalingam S, Horn L, LoRusso P, Bajaj G, Kollia G, Qi Z, Basak S, Fischer B, Davis M, Bedard P. A phase I study of AL101, a pan-NOTCH inhibitor, in patients (pts) with locally advanced or metastatic solid tumors. Journal Of Clinical Oncology 2018, 36: 2515-2515. DOI: 10.1200/jco.2018.36.15_suppl.2515.
  • A randomized Bayesian phase 1 design combining an MPS-1 inhibitor with paclitaxel: A strategy to improve determination of the incremental toxicity of a novel compound over a known backbone therapy.Atrafi F, Boix O, Rajagopalan P, Tolcher A, LoRusso P, Eder J, Sankhala K, Chawla S, Subbiah V, Diamond J, Gutierrez M, Mathijssen R, Mei J, Verweij J, Bruns I, Lolkema M. A randomized Bayesian phase 1 design combining an MPS-1 inhibitor with paclitaxel: A strategy to improve determination of the incremental toxicity of a novel compound over a known backbone therapy. Journal Of Clinical Oncology 2018, 36: 2537-2537. DOI: 10.1200/jco.2018.36.15_suppl.2537.
  • Interim results from a phase 1 trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumors.Wang J, Barve M, Chiorean E, LoRusso P, Courtney K, Qi D, Olguin A, Bullington J, Sardone M, Dunn V, Shemesh S, Chen J, Brooks C, Bauer T. Interim results from a phase 1 trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2018, 36: 2560-2560. DOI: 10.1200/jco.2018.36.15_suppl.2560.
  • Gene expression and cytokine modulation in a first in human (FIH) study of a pan BET inhibitor ABBV-075 in solid tumors.O'Neil B, Modi D, LoRusso P, Wong S, Motwani M, Sachdev J, Wolff J, Patel S, Hu B, Szmulewitz R, Sood A, Barve M, McKee M, Piha-Paul S. Gene expression and cytokine modulation in a first in human (FIH) study of a pan BET inhibitor ABBV-075 in solid tumors. Journal Of Clinical Oncology 2018, 36: 2570-2570. DOI: 10.1200/jco.2018.36.15_suppl.2570.
  • ICONIC: Biologic and clinical activity of first in class ICOS agonist antibody JTX-2011 +/- nivolumab (nivo) in patients (pts) with advanced cancers.Yap T, Burris H, Kummar S, Falchook G, Pachynski R, LoRusso P, Tykodi S, Gibney G, Gainor J, Rahma O, Seiwert T, Meric-Bernstam F, Blum Murphy M, Litton J, Hooper E, Hirsch H, Harvey C, Clancy M, McClure T, Callahan M. ICONIC: Biologic and clinical activity of first in class ICOS agonist antibody JTX-2011 +/- nivolumab (nivo) in patients (pts) with advanced cancers. Journal Of Clinical Oncology 2018, 36: 3000-3000. DOI: 10.1200/jco.2018.36.15_suppl.3000.
  • A phase 1 study of ALX148, a CD47 blocker, alone and in combination with established anticancer antibodies in patients with advanced malignancy and non-Hodgkin lymphoma.Lakhani N, Lakhani N, LoRusso P, Hafez N, Krishnamurthy A, Krishnamurthy A, O'Rourke T, O'Rourke T, Kamdar M, Kamdar M, Fanning P, Fanning P, Zhao Y, Zhao Y, Jin F, Jin F, Wan H, Wan H, Pons J, Pons J, Randolph S, Randolph S, Messersmith W, Messersmith W. A phase 1 study of ALX148, a CD47 blocker, alone and in combination with established anticancer antibodies in patients with advanced malignancy and non-Hodgkin lymphoma. Journal Of Clinical Oncology 2018, 36: 3068-3068. DOI: 10.1200/jco.2018.36.15_suppl.3068.
  • Preliminary interim results of the first-in-human, dose-finding PROCLAIM-CX-072 trial of the PD-L1 Probody therapeutic (Pb-Tx) CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors.Sanborn R, Menke C, Autio K, Arkenau H, Corbacho J, LoRusso P, Plummer E, Uboha N, Freeman M, Wydmanski J, Huels V, Zheng B, Will M, Humphrey R, Thistlethwaite F, de Vries E, El-Khoueiry A. Preliminary interim results of the first-in-human, dose-finding PROCLAIM-CX-072 trial of the PD-L1 Probody therapeutic (Pb-Tx) CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2018, 36: 3072-3072. DOI: 10.1200/jco.2018.36.15_suppl.3072.
  • Safety, efficacy and pharmacodynamics (PD) of MEDI9447 (oleclumab) alone or in combination with durvalumab in advanced colorectal cancer (CRC) or pancreatic cancer (panc).Overman M, LoRusso P, Strickler J, Patel S, Clarke S, Noonan A, Prasanna T, Amin M, Nemunaitis J, Desai J, O'Byrne K, George T, Englert J, She D, Cooper Z, Wu Y, Khan A, Kumar R, Bendell J. Safety, efficacy and pharmacodynamics (PD) of MEDI9447 (oleclumab) alone or in combination with durvalumab in advanced colorectal cancer (CRC) or pancreatic cancer (panc). Journal Of Clinical Oncology 2018, 36: 4123-4123. DOI: 10.1200/jco.2018.36.15_suppl.4123.
  • 32IN Can adding PI3K inhibitors to the treatment cocktail alter outcome?Lorusso P. 32IN Can adding PI3K inhibitors to the treatment cocktail alter outcome? Annals Of Oncology 2018, 29: iii5. DOI: 10.1093/annonc/mdy046.016.
  • Abstract A091: Phase 1 study of IAP inhibitor ASTX660 in adults with advanced cancers and lymphomasMita M, LoRusso P, Gordon M, Oganesian A, Zhang X, Ferraldeschi R, Jueliger S, Keer H, Kumar P, Lin C, Rock E, Mita A, Tolcher A. Abstract A091: Phase 1 study of IAP inhibitor ASTX660 in adults with advanced cancers and lymphomas Molecular Cancer Therapeutics 2018, 17: a091-a091. DOI: 10.1158/1535-7163.targ-17-a091.
  • 90TiP A phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumors, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/- endocrine therapy), or non-small-cell lung cancer (NSCLC)Yee D, Prat A, Sablin M, Iwata H, Johnston E, Bogenrieder T, Serra J, Hua H, LoRusso P. 90TiP A phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumors, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/- endocrine therapy), or non-small-cell lung cancer (NSCLC) Annals Of Oncology 2017, 28: x25. DOI: 10.1093/annonc/mdx656.001.
  • 375PD Phase I study of the checkpoint kinase 1 inhibitor GDC-0575 in combination with gemcitabine (gem) in patients (pts) with refractory solid tumorsItaliano A, Infante J, Shapiro G, Moore K, Lorusso P, Postel-Vinay S, Cousin S, Toulmonde M, Lucchesi C, Blackwood E, Mahrus S, Lu X, Tagen M, Schutzman J, Lauchle J, Soria J. 375PD Phase I study of the checkpoint kinase 1 inhibitor GDC-0575 in combination with gemcitabine (gem) in patients (pts) with refractory solid tumors Annals Of Oncology 2017, 28: v125. DOI: 10.1093/annonc/mdx367.009.
  • 406P Ongoing phase 1 trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumors; Interim resultsWang J, Nemunaitis J, Chiorean G, Lorusso P, Courtney K, Olguin A, Bullington J, Shemesh S, Chen J, Brooks C, Bauer T. 406P Ongoing phase 1 trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumors; Interim results Annals Of Oncology 2017, 28: v135. DOI: 10.1093/annonc/mdx367.039.
  • Abstract CT035: ICONIC: Phase 1/2 trial of ICOS agonist JTX-2011 alone and in combination with nivolumab (nivo)Sears O, Burris H, Tolcher A, Callahan M, Yap T, Kummar S, Falchook G, Pachynski R, Tykodi S, Siewert T, Gibney G, Gainor J, LoRusso P, Lazaro E, Clancy M, Li E, Ding B, Trehu E. Abstract CT035: ICONIC: Phase 1/2 trial of ICOS agonist JTX-2011 alone and in combination with nivolumab (nivo) Cancer Research 2017, 77: ct035-ct035. DOI: 10.1158/1538-7445.am2017-ct035.
  • Abstract CT107: A Phase Ib study to evaluate the MEK inhibitor cobimetinib in combination with the ERK1/2 inhibitor GDC-0994 in patients with advanced solid tumorsWeekes C, Lockhard A, LoRusso P, Murray E, Park E, Tagen M, Mueller L, Dokainish H, Shapiro G, Burris H. Abstract CT107: A Phase Ib study to evaluate the MEK inhibitor cobimetinib in combination with the ERK1/2 inhibitor GDC-0994 in patients with advanced solid tumors Cancer Research 2017, 77: ct107-ct107. DOI: 10.1158/1538-7445.am2017-ct107.
  • Phase I study combining the aurora kinase A (AURKA) inhibitor alisertib (Ali) with mFOLFOX in gastrointestinal (GI) cancer.Goff L, Azad N, Stein S, Whisenant J, Vaishampayan U, Hochster H, Connolly R, Weise A, LoRusso P, El-Rifai W, Berlin J. Phase I study combining the aurora kinase A (AURKA) inhibitor alisertib (Ali) with mFOLFOX in gastrointestinal (GI) cancer. Journal Of Clinical Oncology 2017, 35: 2593-2593. DOI: 10.1200/jco.2017.35.15_suppl.2593.
  • A phase Ib dose escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients (pts) with locally advanced or metastatic solid tumors.Burris H, Gordon M, Hellmann M, LoRusso P, Emens L, Hodi F, Lieu C, Infante J, Tsai F, Eder J, Cleary J, Jelovac D, Tsuhako A, Mueller L, Lin R, Morrissey K, Mahrus S, Morley R, Pirzkall A, Davis S. A phase Ib dose escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients (pts) with locally advanced or metastatic solid tumors. Journal Of Clinical Oncology 2017, 35: 105-105. DOI: 10.1200/jco.2017.35.15_suppl.105.
  • Dose escalation results from a first-in-human, phase 1 study of the glucocorticoid-induced TNF receptor-related protein (GITR) agonist AMG 228 in patients (Pts) with advanced solid tumors.Tran B, Carvajal R, Marabelle A, Patel S, LoRusso P, Rasmussen E, Juan G, Upreti V, Ngarmchamnanrith G, Schöffski P. Dose escalation results from a first-in-human, phase 1 study of the glucocorticoid-induced TNF receptor-related protein (GITR) agonist AMG 228 in patients (Pts) with advanced solid tumors. Journal Of Clinical Oncology 2017, 35: 2521-2521. DOI: 10.1200/jco.2017.35.15_suppl.2521.
  • A call for global harmonization of phase I oncology trials: Results from two parallel, first-in-human phase I studies of DS-7423, an oral PI3K/mTOR dual inhibitor in advanced solid tumors conducted in the United States and Japan.Yokota T, Bendell J, LoRusso P, Tsushima T, Desai V, Kenmotsu H, Watanabe J, Ono A, Murugesan B, Silva J, Naito T, Greenberg J, Kumar P, Wang Y, Jikoh T, Shiga R, Ho A, Gounder M. A call for global harmonization of phase I oncology trials: Results from two parallel, first-in-human phase I studies of DS-7423, an oral PI3K/mTOR dual inhibitor in advanced solid tumors conducted in the United States and Japan. Journal Of Clinical Oncology 2017, 35: 2536-2536. DOI: 10.1200/jco.2017.35.15_suppl.2536.
  • A phase Ia study of CC-90003, a selective extracellular signal-regulated kinase (ERK) inhibitor, in patients with relapsed or refractory BRAF or RAS-mutant tumors.Mita M, LoRusso P, McArthur G, Kim E, Bray G, Hock N, Laille E, Aronchik I, Filvaroff E, Wu X, Bendell J. A phase Ia study of CC-90003, a selective extracellular signal-regulated kinase (ERK) inhibitor, in patients with relapsed or refractory BRAF or RAS-mutant tumors. Journal Of Clinical Oncology 2017, 35: 2577-2577. DOI: 10.1200/jco.2017.35.15_suppl.2577.
  • Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC.Burris H, Callahan M, Tolcher A, Kummar S, Falchook G, Pachynski R, Tykodi S, Gibney G, Seiwert T, Gainor J, LoRusso P, Hilbert J, Apgar J, Hua F, Burke J, Lazaro M, Clancy M, Ding B, Trehu E, Yap T. Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC. Journal Of Clinical Oncology 2017, 35: 3033-3033. DOI: 10.1200/jco.2017.35.15_suppl.3033.
  • Abstract P4-21-40: In vitro and in vivo activity of HER2-targeted antibody-liposomal doxorubicin conjugate MM-302 in HER2-intermediate tumorsGeretti E, Espelin C, Adiwijaya B, Coma S, Koncki Z, Sumner P, Dumont N, Garcia G, Bloom T, Janovsky J, Reynolds J, Campbell K, Moyo V, Molnar I, LoRusso P, Krop I, Miller K, Ma C, Munster P, Wickham T. Abstract P4-21-40: In vitro and in vivo activity of HER2-targeted antibody-liposomal doxorubicin conjugate MM-302 in HER2-intermediate tumors Cancer Research 2017, 77: p4-21-40-p4-21-40. DOI: 10.1158/1538-7445.sabcs16-p4-21-40.
  • P2.03a-065 Lack of Drug-Drug Interaction (DDI) between Necitumumab and Gemcitabine or Cisplatin: A Phase 2, Open-Label, Nonrandomized Study Topic: Clinical TrialsChaudhary A, Chao G, Braiteh F, Gordon M, Lee J, Lorusso P, Obasaju C, Wallin J. P2.03a-065 Lack of Drug-Drug Interaction (DDI) between Necitumumab and Gemcitabine or Cisplatin: A Phase 2, Open-Label, Nonrandomized Study Topic: Clinical Trials Journal Of Thoracic Oncology 2017, 12: s928-s929. DOI: 10.1016/j.jtho.2016.11.1275.
  • 18 A first-in-human phase I study to evaluate the ERK1/2 inhibitor GDC-0994 in patients with advanced solid tumorsVarga A, Soria J, Hollebecque A, LoRusso P, Vaishampayan U, Okrah K, Huang S, Murray E, Sanabria-Bohorquez S, Tagen M, Dokainish H, Mueller L, Burris H. 18 A first-in-human phase I study to evaluate the ERK1/2 inhibitor GDC-0994 in patients with advanced solid tumors European Journal Of Cancer 2016, 69: s11. DOI: 10.1016/s0959-8049(16)32624-7.
  • Antibody–Drug Conjugates (ADCs) in Clinical DevelopmentMcLaughlin J, LoRusso P. Antibody–Drug Conjugates (ADCs) in Clinical Development 2016, 321-344. DOI: 10.1002/9781119060727.ch13.
  • ACTR-10. PHASE 0 TRIAL OF AZD1775 IN FIRST-RECURRENCE GLIOBLASTOMA PATIENTSSanai N, Li J, Boerner J, Dhruv H, Berens M, LoRusso P. ACTR-10. PHASE 0 TRIAL OF AZD1775 IN FIRST-RECURRENCE GLIOBLASTOMA PATIENTS Neuro-Oncology 2016, 18: vi3-vi3. DOI: 10.1093/neuonc/now212.009.
  • 1560P Quantitative evaluation of HER2-mediated cellular uptake of the HER2-targeted antibody-liposomal doxorubicin conjugate MM-302 suggests potential for treating HER2-intermediate tumorsGeretti E, Espelin C, Adiwijaya B, Dumont N, Coma S, Koncki Z, Garcia G, Bloom T, Rimkunas V, Reynolds J, Campbell K, Moyo V, Molnar I, Lorusso P, Miller K, Ma C, Krop I, Munster P, Wickham T. 1560P Quantitative evaluation of HER2-mediated cellular uptake of the HER2-targeted antibody-liposomal doxorubicin conjugate MM-302 suggests potential for treating HER2-intermediate tumors Annals Of Oncology 2016, 27: vi539. DOI: 10.1093/annonc/mdw392.41.
  • 357O A phase I study evaluating DLYE5953A, an antibody-drug conjugate targeting the tumor-associated antigen lymphocyte antigen 6 complex locus E (Ly6E), in patients (Pts) with solid tumorsModi S, Eder J, Lorusso P, Weekes C, Chandarlapaty S, Tolaney S, McLaughlin J, Camidge D, Chang C, Nazzal D, Chen S, Schuth E, Brunstein F, Darbonne W, Flanagan W, Ungewickell A, Shapiro G. 357O A phase I study evaluating DLYE5953A, an antibody-drug conjugate targeting the tumor-associated antigen lymphocyte antigen 6 complex locus E (Ly6E), in patients (Pts) with solid tumors Annals Of Oncology 2016, 27: vi114. DOI: 10.1093/annonc/mdw368.01.
  • Abstract LB-061: HER2-targeted PEGylated liposomal doxorubicin (MM-302) efficiently targets the HER2 intermediate cell population in vitro and in vivoGeretti E, Espelin C, Adiwijaya B, Dumont N, Coma S, Koncki Z, Pham M, Garcia G, Bloom T, Rimkunas V, Reynolds J, Campbell K, Moyo V, Molnar I, LoRusso P, Krop I, Miller K, Ma C, Munster P, Wickham T. Abstract LB-061: HER2-targeted PEGylated liposomal doxorubicin (MM-302) efficiently targets the HER2 intermediate cell population in vitro and in vivo Cancer Research 2016, 76: lb-061-lb-061. DOI: 10.1158/1538-7445.am2016-lb-061.
  • Safety, pharmacokinetics (PK), pharmacodynamics (Pd), and antitumor activity in a phase 1b study evaluating anti-ErbB3 antibody KTN3379 in adults with advanced tumors alone and with targeted therapies.Falchook G, Bauer T, LoRusso P, McLaughlin J, LaVallee T, Peck R, Eder J. Safety, pharmacokinetics (PK), pharmacodynamics (Pd), and antitumor activity in a phase 1b study evaluating anti-ErbB3 antibody KTN3379 in adults with advanced tumors alone and with targeted therapies. Journal Of Clinical Oncology 2016, 34: 2501-2501. DOI: 10.1200/jco.2016.34.15_suppl.2501.
  • Trabectedin (T)-related liver toxicity: Results of a pharmacokinetic study with T in patients with hepatic dysfunction (OVC1004) and experience from a phase 3 clinical trial (SAR3007).Calvo E, Azaro A, Dirix L, Huizing M, Senecal F, LoRusso P, Yee L, Keung C, Triantos S, Park Y, Knoblauch R, Parekh T, Demetri G, vonMehren M. Trabectedin (T)-related liver toxicity: Results of a pharmacokinetic study with T in patients with hepatic dysfunction (OVC1004) and experience from a phase 3 clinical trial (SAR3007). Journal Of Clinical Oncology 2016, 34: 11064-11064. DOI: 10.1200/jco.2016.34.15_suppl.11064.
  • Phase 0 trial of AZD1775 in patients with first-recurrence glioblastoma.Sanai N, Li J, Boerner J, Dhruv H, Berens M, LoRusso P. Phase 0 trial of AZD1775 in patients with first-recurrence glioblastoma. Journal Of Clinical Oncology 2016, 34: 2008-2008. DOI: 10.1200/jco.2016.34.15_suppl.2008.
  • A phase 1 study of the MDM2 inhibitor DS-3032b in patients (pts) with advanced solid tumors and lymphomas.Gounder M, Bauer T, Schwartz G, Masters T, Carvajal R, Song S, Kumar P, Gajee R, Zernovak O, Rosen M, Kochan J, Chen S, Hyman D, Gokmen S, Meric-Bernstam F, LoRusso P, Somaiah N, Weise A, Hong D. A phase 1 study of the MDM2 inhibitor DS-3032b in patients (pts) with advanced solid tumors and lymphomas. Journal Of Clinical Oncology 2016, 34: 2581-2581. DOI: 10.1200/jco.2016.34.15_suppl.2581.
  • A phase I study of continuous (Con) and intermittent (Int) AZD2014 plus fulvestrant (F) in patients (pts) with estrogen receptor (ER+) metastatic breast cancer (BC).Hamilton E, Patel M, Gluck W, Weise A, Pant S, Jones S, LoRusso P, Kittaneh M, Cosulich S, Harrington E, Littlewood G, Oelmann E, Burris H. A phase I study of continuous (Con) and intermittent (Int) AZD2014 plus fulvestrant (F) in patients (pts) with estrogen receptor (ER+) metastatic breast cancer (BC). Journal Of Clinical Oncology 2016, 34: 563-563. DOI: 10.1200/jco.2016.34.15_suppl.563.
  • Abstract S5-05: Trastuzumab emtansine improves overall survival versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer: Final overall survival results from the phase 3 TH3RESA studyWildiers H, Kim S, Gonzalez-Martin A, LoRusso P, Ferrero J, Yu R, Smitt M, Krop I. Abstract S5-05: Trastuzumab emtansine improves overall survival versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer: Final overall survival results from the phase 3 TH3RESA study Cancer Research 2016, 76: s5-05-s5-05. DOI: 10.1158/1538-7445.sabcs15-s5-05.
  • Abstract A49: Clinically efficacy of the BET bromodomain inhibitor TEN-010 in an open-label substudy with patients with documented NUT-midline carcinoma (NMC)Shapiro G, Dowlati A, LoRusso P, Eder J, Anderson A, Do K, Kagey M, Sirard C, Bradner J, Landau S. Abstract A49: Clinically efficacy of the BET bromodomain inhibitor TEN-010 in an open-label substudy with patients with documented NUT-midline carcinoma (NMC) Molecular Cancer Therapeutics 2015, 14: a49-a49. DOI: 10.1158/1535-7163.targ-15-a49.
  • Abstract B144: Evaluation of total and encapsulated drug pharmacokinetics for BIND-014 (docetaxel nanoparticles for injectable suspension) in a phase 1 studySumma J, Von Hoff D, Sachdev J, Mita M, LoRusso P, Eisenberg P, Burris H, Hart L, Youssoufian H, Parsons D, Low S. Abstract B144: Evaluation of total and encapsulated drug pharmacokinetics for BIND-014 (docetaxel nanoparticles for injectable suspension) in a phase 1 study Molecular Cancer Therapeutics 2015, 14: b144-b144. DOI: 10.1158/1535-7163.targ-15-b144.
  • Abstract B27: A phase I dose escalation study of the MDM2 inhibitor DS-3032b in patients with advanced solid tumors and lymphomasBauer T, Hong D, Somaiah N, Cai C, Song S, Kumar P, Gajee R, Rosen M, Kochan J, Chen S, Hyman D, Masters T, Meric-Bernstam F, Tse A, LoRusso P, Weise A, Gounder M. Abstract B27: A phase I dose escalation study of the MDM2 inhibitor DS-3032b in patients with advanced solid tumors and lymphomas Molecular Cancer Therapeutics 2015, 14: b27-b27. DOI: 10.1158/1535-7163.targ-15-b27.
  • Abstract C45: Phase I study of WNT974, a first-in-class Porcupine inhibitor, in advanced solid tumorsJanku F, Connolly R, LoRusso P, de Jonge M, Vaishampayan U, Rodon J, Argilés G, Myers A, Hsu Schmitz S, Ji Y, McLaughlin M, Palmer M, Morawiak J. Abstract C45: Phase I study of WNT974, a first-in-class Porcupine inhibitor, in advanced solid tumors Molecular Cancer Therapeutics 2015, 14: c45-c45. DOI: 10.1158/1535-7163.targ-15-c45.
  • Abstract 1310: Programmed death ligand-1 (PD-L1) heterogeneity in non-small cell lung cancer (NSCLC)McLaughlin J, Schalper K, Carvajal-Hausdorf D, Pelekanou V, Velcheti V, Haack H, Silver M, Herbst R, LoRusso P, Rimm D. Abstract 1310: Programmed death ligand-1 (PD-L1) heterogeneity in non-small cell lung cancer (NSCLC) 2015, 1310-1310. DOI: 10.1158/1538-7445.am2015-1310.
  • Abstract CT234: A phase I study of MM-302, a HER2-targeted PEGylated liposomal doxorubicin, in patients with HER2+ metastatic breast cancerLoRusso P, Krop I, Miller K, Ma C, Siegel B, Shields A, Molnar I, Wickham T, Reynolds J, Campbell K, Hendriks B, McClure T, Moyo V, Munster P. Abstract CT234: A phase I study of MM-302, a HER2-targeted PEGylated liposomal doxorubicin, in patients with HER2+ metastatic breast cancer 2015, ct234-ct234. DOI: 10.1158/1538-7445.am2015-ct234.
  • Abstract 5514: Pharmacokinetics of BIND-014 (docetaxel nanoparticles for injectable suspension) in preclinical species and patients with advanced solid tumorsSumma J, Von Hoff D, Sachdev J, Mita M, LoRusso P, Eisenberg P, Burris H, Hart L, Youssoufian H, Parsons D, Low S. Abstract 5514: Pharmacokinetics of BIND-014 (docetaxel nanoparticles for injectable suspension) in preclinical species and patients with advanced solid tumors 2015, 5514-5514. DOI: 10.1158/1538-7445.am2015-5514.
  • Abstract CT139: Phase I study of GDC-0425, a checkpoint kinase 1 inhibitor, in combination with gemcitabine in patients with refractory solid tumorsInfante J, Hollebecque A, Postel-Vinay S, Bauer T, Blackwood B, Evangelista M, Mahrus S, Peale F, Lu X, Sahasranaman S, Zhu R, Chen Y, Ding X, Murray E, Schutzman J, Lauchle J, Soria J, LoRusso P. Abstract CT139: Phase I study of GDC-0425, a checkpoint kinase 1 inhibitor, in combination with gemcitabine in patients with refractory solid tumors 2015, ct139-ct139. DOI: 10.1158/1538-7445.am2015-ct139.
  • Abstract CT233: A phase I study evaluating continuous and intermittent AZD2014 in combination with fulvestrant in patients with ER+ advanced metastatic breast cancerPatel M, Hamilton E, LoRusso P, Gluck W, Jones S, Kittaneh M, Cosulich S, Harrington E, Green S, Burke W, Strickland D, Oelmann E, Burris H. Abstract CT233: A phase I study evaluating continuous and intermittent AZD2014 in combination with fulvestrant in patients with ER+ advanced metastatic breast cancer 2015, ct233-ct233. DOI: 10.1158/1538-7445.am2015-ct233.
  • Abstract CT237: Preclinical characterization and first-in-human study of MM-141, a dual antibody inhibitor of IGF-1R and ErbB3Lugovskoy A, Curley M, Baum J, Adams S, Iadevaia S, Rimkunas V, Camblin A, Nie L, Tan G, Johnson B, Mathews S, Horgan K, Louis C, Czibere A, Arnedos M, Soria J, Bahleda R, Shields A, LoRusso P, Saleh M, Isakoff S. Abstract CT237: Preclinical characterization and first-in-human study of MM-141, a dual antibody inhibitor of IGF-1R and ErbB3 2015, ct237-ct237. DOI: 10.1158/1538-7445.am2015-ct237.
  • Abstract CT308: Pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies and hepatic dysfunctionAbou-Alfa G, Lewis L, LoRusso P, Maitland M, Cheeti S, Colburn D, Williams S, Simmons B, Graham R, Chandra P. Abstract CT308: Pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies and hepatic dysfunction 2015, ct308-ct308. DOI: 10.1158/1538-7445.am2015-ct308.
  • Abstract CT325: Combination of the PARP inhibitor veliparib (ABT888) with irinotecan in patients with triple negative breast cancer: Preliminary activity and signature of responseLoRusso P, Tolaney S, Wong S, Parchment R, Kinders R, Wang L, Aldrich J, Chen A, Durecki D, Boerner S, Guthrie T, Bowditch A, Heilbrun L, Pilat M, Craig D, Cai D, Bell T, Carpten J, Shapiro G. Abstract CT325: Combination of the PARP inhibitor veliparib (ABT888) with irinotecan in patients with triple negative breast cancer: Preliminary activity and signature of response 2015, ct325-ct325. DOI: 10.1158/1538-7445.am2015-ct325.
  • Phase I dose-finding study of the gamma secretase inhibitor PF-03084014 (PF-4014) in combination with docetaxel in patients (pts) with advanced triple-negative breast cancer (TNBC).Curigliano G, Aftimos P, Dees E, LoRusso P, Pegram M, Awada A, Huang B, Cesari R, Jiang Y, Shaik M, Kern K, Locatelli M. Phase I dose-finding study of the gamma secretase inhibitor PF-03084014 (PF-4014) in combination with docetaxel in patients (pts) with advanced triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2015, 33: 1068-1068. DOI: 10.1200/jco.2015.33.15_suppl.1068.
  • First-in-human, phase I, dose-escalation study of selective PI3Kα isoform inhibitor MLN1117 in patients (pts) with advanced solid malignancies.Juric D, De Bono J, LoRusso P, Nemunaitis J, Heath E, Kwak E, Macarulla T, Geuna E, de Miguel Luken M, Patel C, Kuida K, Sankoh S, Zohren F, Shou Y, Tabernero J. First-in-human, phase I, dose-escalation study of selective PI3Kα isoform inhibitor MLN1117 in patients (pts) with advanced solid malignancies. Journal Of Clinical Oncology 2015, 33: 2501-2501. DOI: 10.1200/jco.2015.33.15_suppl.2501.
  • Phase 1, first-in-human study of ARQ 087, an oral pan-Fibroblast Growth Factor Receptor (FGFR) inhibitor, in patients (pts) with advanced solid tumors.Papadopoulos K, Tolcher A, Patnaik A, Rasco D, Chambers G, Beeram M, Savage R, Hall T, Schwartz B, Kazakin J, LoRusso P. Phase 1, first-in-human study of ARQ 087, an oral pan-Fibroblast Growth Factor Receptor (FGFR) inhibitor, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2015, 33: 2545-2545. DOI: 10.1200/jco.2015.33.15_suppl.2545.
  • A phase 1, open-label study to evaluate the safety and pharmacokinetics of the anti ErbB3 antibody, KTN3379, alone or in combination with targeted therapies in patients with advanced tumors.Bauer T, Infante J, Eder J, LoRusso P, LaVallee T, Gedrich R, Sidor C, Falchook G. A phase 1, open-label study to evaluate the safety and pharmacokinetics of the anti ErbB3 antibody, KTN3379, alone or in combination with targeted therapies in patients with advanced tumors. Journal Of Clinical Oncology 2015, 33: 2598-2598. DOI: 10.1200/jco.2015.33.15_suppl.2598.
  • Pulmonary function tests (PFT) results in a phase 1 (Ph1) oncology patient (pt) population.Goncalves P, Soubani A, Heilbrun L, Smith D, Villegas J, LoRusso P. Pulmonary function tests (PFT) results in a phase 1 (Ph1) oncology patient (pt) population. Journal Of Clinical Oncology 2015, 33: e17759-e17759. DOI: 10.1200/jco.2015.33.15_suppl.e17759.
  • First-in-human, dose-escalation, safety, and PK study of a novel 5T4-ADC in patients with advanced solid tumors.Shapiro G, LoRusso P, Vaishampayan U, Kittaneh M, Hilton J, Cleary J, Velastegui K, Xuan D, Hua S, Shazer R, Borghaei H. First-in-human, dose-escalation, safety, and PK study of a novel 5T4-ADC in patients with advanced solid tumors. Journal Of Clinical Oncology 2015, 33: tps2603-tps2603. DOI: 10.1200/jco.2015.33.15_suppl.tps2603.
  • Abstract OT2-3-01: SGN-LIV1A: A phase 1 trial evaluating a novel antibody-drug conjugate in patients with LIV-1-positive breast cancerForero A, Burris III H, LoRusso P, Specht J, Miller K, Mita M, Liu M, Modi S, Pusztai L, Sussman D, Kostic A. Abstract OT2-3-01: SGN-LIV1A: A phase 1 trial evaluating a novel antibody-drug conjugate in patients with LIV-1-positive breast cancer 2015, ot2-3-01-ot2-3-01. DOI: 10.1158/1538-7445.sabcs14-ot2-3-01.
  • Abstract P4-15-04: Effect of pre-treatment with cyclophosphamide on MM-302 (HER2-targeted liposomal doxorubicin) deposition in HER2-positive metastatic breast cancer patients assessed by 64 Cu-MM-302 PET/CTMiller K, LoRusso P, Munster P, Krop I, Ma C, Lee H, Reynolds J, Campbell K, Moyo V, Hendriks B, Wickham T, Siegel B, Shields A. Abstract P4-15-04: Effect of pre-treatment with cyclophosphamide on MM-302 (HER2-targeted liposomal doxorubicin) deposition in HER2-positive metastatic breast cancer patients assessed by 64 Cu-MM-302 PET/CT 2015, p4-15-04-p4-15-04. DOI: 10.1158/1538-7445.sabcs14-p4-15-04.
  • Abstract P6-12-01: A phase I study evaluating AZD2014 in combination with fulvestrant in patients with ER+ advanced metastatic breast cancerBurris III H, LoRusso P, Gluck W, Jones S, Kittaneh M, Hamilton E, Green S, Burke W, Strickland D, Oelmann E, Patel M. Abstract P6-12-01: A phase I study evaluating AZD2014 in combination with fulvestrant in patients with ER+ advanced metastatic breast cancer 2015, p6-12-01-p6-12-01. DOI: 10.1158/1538-7445.sabcs14-p6-12-01.
  • Clinical activity of AMG 337, an oral MET kinase inhibitor, in adult patients (pts) with MET-amplified gastroesophageal junction (GEJ), gastric (G), or esophageal (E) cancer.Kwak E, LoRusso P, Hamid O, Janku F, Kittaneh M, Catenacci D, Chan E, Bekaii-Saab T, Amore B, Hwang Y, Tang R, Ngarmchamnanrith G, Hong D. Clinical activity of AMG 337, an oral MET kinase inhibitor, in adult patients (pts) with MET-amplified gastroesophageal junction (GEJ), gastric (G), or esophageal (E) cancer. Journal Of Clinical Oncology 2015, 33: 1-1. DOI: 10.1200/jco.2015.33.3_suppl.1.
  • Phase I study of ABT-700, an anti-c-Met antibody, in patients (pts) with advanced gastric or esophageal cancer (GEC).Kang Y, LoRusso P, Salgia R, Yen C, Lin C, Ramanathan R, Kaminker P, Sokolova I, Bhathena A, Wang L, Naumovski L, Strickler J. Phase I study of ABT-700, an anti-c-Met antibody, in patients (pts) with advanced gastric or esophageal cancer (GEC). Journal Of Clinical Oncology 2015, 33: 167-167. DOI: 10.1200/jco.2015.33.3_suppl.167.
  • Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors.Wang D, Braiteh F, Lee J, Denlinger C, Shepard D, Chaudhary A, Lin Y, Gao L, Asakiewicz C, Nasroulah F, LoRusso P. Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors. Journal Of Clinical Oncology 2015, 33: 691-691. DOI: 10.1200/jco.2015.33.3_suppl.691.
  • 48 Phase I Trials TodayMorgensztern D, LoRusso P, Boerner S, Herbst R, Eder J. 48 Phase I Trials Today 2015, 661-676.e2. DOI: 10.1016/b978-1-4557-4066-6.00048-2.
  • 2 Safety and early evidence of activity of a first-in-human phase I study of the novel cancer stem cell (CSC) targeting antibody OMP-52M51 (anti-Notch1) administered intravenously to patients with certain advanced solid tumorsPatnaik A, LoRusso P, Munster P, Tolcher A, Davis S, Heymach J, Ferraroto R, Xu L, Kapoun A, Faoro L, Lewicki J, Dupont J, Eckhardt S. 2 Safety and early evidence of activity of a first-in-human phase I study of the novel cancer stem cell (CSC) targeting antibody OMP-52M51 (anti-Notch1) administered intravenously to patients with certain advanced solid tumors European Journal Of Cancer 2014, 50: 7. DOI: 10.1016/s0959-8049(14)70128-5.
  • 210 A phase 1 study of KTN3379, a human anti-ErbB3 monoclonal antibody in patients with advanced cancersLoRusso P, LaVallee T, Kimmel L, Lubeski C, Gedrich R, Sidor C. 210 A phase 1 study of KTN3379, a human anti-ErbB3 monoclonal antibody in patients with advanced cancers European Journal Of Cancer 2014, 50: 71. DOI: 10.1016/s0959-8049(14)70336-3.
  • 389 A phase 1, dose-escalation, first-in-human study of ARQ 087, an oral pan-FGFR inhibitor, in adult subjects with advanced solid tumorsPapadopoulos K, Tolcher A, Kittaneh M, Patniak A, Rasco D, Chambers G, Newth G, Savage R, Hall T, Schwartz B, Kazakin J, LoRusso P. 389 A phase 1, dose-escalation, first-in-human study of ARQ 087, an oral pan-FGFR inhibitor, in adult subjects with advanced solid tumors European Journal Of Cancer 2014, 50: 125. DOI: 10.1016/s0959-8049(14)70515-5.
  • Abstract 3417: The genomic landscape of canine melanoma reveals broad mutational heterogeneity and recurrent patterns of structural variationHendricks W, Zismann V, Button B, Legendre C, Tembe W, Yin H, Bittner M, Berry D, Huentelman M, Khanna C, LoRusso P, Breen M, Sekulic A, Trent J. Abstract 3417: The genomic landscape of canine melanoma reveals broad mutational heterogeneity and recurrent patterns of structural variation 2014, 3417-3417. DOI: 10.1158/1538-7445.am2014-3417.
  • Abstract 911: Prostate-specific membrane antigen (PSMA) expression as a potential patient selection marker in patients with refractory solid tumors administered BIND-014, a PSMA-targeted nanoparticle containing docetaxelLow S, Hoff D, Mita M, Burris H, Eisenberg P, Hart L, LoRusso P, Weiss G, Sachdev J, Mita A, Ramanathan R, Hrkach J, Summa J, Berk G. Abstract 911: Prostate-specific membrane antigen (PSMA) expression as a potential patient selection marker in patients with refractory solid tumors administered BIND-014, a PSMA-targeted nanoparticle containing docetaxel 2014, 911-911. DOI: 10.1158/1538-7445.am2014-911.
  • Abstract CT210: A phase 1 study of BIND-014, a PSMA-targeted nanoparticle containing docetaxel, administered to patients with refractory solid tumors on a weekly scheduleMita M, Burris H, LoRusso P, Hart L, Eisenberg P, Mita A, Low S, Summa J, Berk G, Sachdev J. Abstract CT210: A phase 1 study of BIND-014, a PSMA-targeted nanoparticle containing docetaxel, administered to patients with refractory solid tumors on a weekly schedule 2014, ct210-ct210. DOI: 10.1158/1538-7445.am2014-ct210.
  • Abstract CT326: Phase I study of BGJ398, a selective pan-FGFR inhibitor in genetically preselected advanced solid tumorsSequist L, Cassier P, Varga A, Tabernero J, Schellens J, Delord J, LoRusso P, Camidge D, Medina M, Schuler M, Campone M, Tian G, Wong S, Corral J, Isaacs R, Sen S, Porta D, Kulkarni S, Lefebvre C, Wolf J. Abstract CT326: Phase I study of BGJ398, a selective pan-FGFR inhibitor in genetically preselected advanced solid tumors 2014, ct326-ct326. DOI: 10.1158/1538-7445.am2014-ct326.
  • Abstract CT328: Clinical results of a phase Ib dose-escalation study of the Mek inhibitor cobimetinib (GDC-0973) and the Akt inhibitor ipatasertib (GDC-0068) in patients (pts) with solid tumorsBendell J, LoRusso P, Cho D, Musib L, Yan Y, Chang I, Patel P, Chang I, Meng R, Shapiro G. Abstract CT328: Clinical results of a phase Ib dose-escalation study of the Mek inhibitor cobimetinib (GDC-0973) and the Akt inhibitor ipatasertib (GDC-0068) in patients (pts) with solid tumors 2014, ct328-ct328. DOI: 10.1158/1538-7445.am2014-ct328.
  • 882PD Phase 1/2 Study of Oral Rucaparib: Updated Phase 1 and Preliminary Phase 2 ResultsKristeleit R, Shapira-Frommer R, Burris H, Patel M, Lorusso P, Oza A, Balmaña J, Domchek S, Chen L, Montes A, Plummer R, Arkenau H, Maloney L, Dominy E, Shapiro G. 882PD Phase 1/2 Study of Oral Rucaparib: Updated Phase 1 and Preliminary Phase 2 Results Annals Of Oncology 2014, 25: iv307. DOI: 10.1093/annonc/mdu338.8.
  • Phase 1, open-label, dose-escalation, and expansion study of ABT-700, an anti-C-met antibody, in patients (pts) with advanced solid tumors.Strickler J, LoRusso P, Yen C, Lin C, Kang Y, Kaminker P, Ansell P, Bhathena A, Wong S, Dudley M, Naumovski L, Ramanathan R. Phase 1, open-label, dose-escalation, and expansion study of ABT-700, an anti-C-met antibody, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2014, 32: 2507-2507. DOI: 10.1200/jco.2014.32.15_suppl.2507.
  • First-in-human study of AMG 337, a highly selective oral inhibitor of MET, in adult patients (pts) with advanced solid tumors.Hong D, LoRusso P, Hamid O, Beaupre D, Janku F, Khan R, Kittaneh M, Loberg R, Amore B, Caudillo I, Hwang Y, Tang R, Ngarmchamnanrith G, Kwak E. First-in-human study of AMG 337, a highly selective oral inhibitor of MET, in adult patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2014, 32: 2508-2508. DOI: 10.1200/jco.2014.32.15_suppl.2508.
  • Early phase I study of the PARP inhibitor veliparib (ABT-888) alone or in combination with carboplatin/paclitaxel (CP) in patients with varying degrees of hepatic or renal dysfunction: A study of the NCI-Organ Dysfunction Working Group (ODG).Tawbi H, Chu E, Lin Y, Hyman D, Goel S, Rudek M, Dowlati A, LoRusso P, Mulkerin D, Chew H, Kiesel B, Pollice L, Appleman L, Puhalla S, Stoller R, Lee J, Ivy P, Beumer J. Early phase I study of the PARP inhibitor veliparib (ABT-888) alone or in combination with carboplatin/paclitaxel (CP) in patients with varying degrees of hepatic or renal dysfunction: A study of the NCI-Organ Dysfunction Working Group (ODG). Journal Of Clinical Oncology 2014, 32: 2572-2572. DOI: 10.1200/jco.2014.32.15_suppl.2572.
  • Phase 1/2 study of oral rucaparib: Final phase 1 results.Kristeleit R, Burris H, LoRusso P, Patel M, Asghar U, El-Khouly F, Calvert A, Infante J, Hilton J, Tolaney S, Kittaneh M, Giordano H, Borrow J, Jaw-Tsai S, Shapiro G. Phase 1/2 study of oral rucaparib: Final phase 1 results. Journal Of Clinical Oncology 2014, 32: 2573-2573. DOI: 10.1200/jco.2014.32.15_suppl.2573.
  • Safety, activity, and pharmacokinetics of an oral anaplastic lymphoma kinase (ALK) inhibitor, ASP3026, observed in a “fast follower” phase 1 trial design.Maitland M, Ou S, Tolcher A, LoRusso P, Bahceci E, Ball H, Park J, Yuen G, Pesco Koplowitz L, Li T. Safety, activity, and pharmacokinetics of an oral anaplastic lymphoma kinase (ALK) inhibitor, ASP3026, observed in a “fast follower” phase 1 trial design. Journal Of Clinical Oncology 2014, 32: 2624-2624. DOI: 10.1200/jco.2014.32.15_suppl.2624.
  • First-in-human study of MM-141: A novel tetravalent monoclonal antibody targeting IGF-1R and ErbB3.Isakoff S, Saleh M, Lugovskoy A, Manoli S, Czibere A, LoRusso P, Arnedos M. First-in-human study of MM-141: A novel tetravalent monoclonal antibody targeting IGF-1R and ErbB3. Journal Of Clinical Oncology 2014, 32: 3068-3068. DOI: 10.1200/jco.2014.32.15_suppl.3068.
  • Enzalutamide plus exemestane: A pilot study to assess safety, pharmacokinetics, and effects on circulating estrogens in women with advanced hormone-positive breast cancer.Schwartzberg L, Yardley D, Elias A, Patel M, Gucalp A, Burris H, Peterson A, Hannah A, Blaney M, Gibbons J, Tudor I, Steinberg J, LoRusso P, Infante J, Hudis C, Traina T. Enzalutamide plus exemestane: A pilot study to assess safety, pharmacokinetics, and effects on circulating estrogens in women with advanced hormone-positive breast cancer. Journal Of Clinical Oncology 2014, 32: 545-545. DOI: 10.1200/jco.2014.32.15_suppl.545.
  • Relationship of pharmacokinetics (PK), toxicity, and initial evidence of clinical activity with IMGN853, a folate receptor alpha (FRa) targeting antibody drug conjugate in patients (Pts) with epithelial ovarian cancer (EOC) and other FRa-positive solid tumors.Moore K, Ponte J, LoRusso P, Birrer M, Bauer T, Borghaei H, O'Malley D, Ruiz-Soto R, Lutz R, Malik L. Relationship of pharmacokinetics (PK), toxicity, and initial evidence of clinical activity with IMGN853, a folate receptor alpha (FRa) targeting antibody drug conjugate in patients (Pts) with epithelial ovarian cancer (EOC) and other FRa-positive solid tumors. Journal Of Clinical Oncology 2014, 32: 5571-5571. DOI: 10.1200/jco.2014.32.15_suppl.5571.
  • Vismodegib in the treatment of patients with metastatic basal cell carcinoma (mBCC) and distant metastases: Survival in the pivotal phase II and phase I studies.Lewis K, Sekulic A, Hauschild A, Migden M, Oro A, LoRusso P, Rudin C, Dirix L, Solomon J, Hainsworth J, Williams S, Hou J, Von Hoff D. Vismodegib in the treatment of patients with metastatic basal cell carcinoma (mBCC) and distant metastases: Survival in the pivotal phase II and phase I studies. Journal Of Clinical Oncology 2014, 32: 9012-9012. DOI: 10.1200/jco.2014.32.15_suppl.9012.
  • 55P PET/CT Imaging of 64CU-Labelled HER2 Liposomal Doxorubicin (64CU-MM-302) Quantifies Variability of Liposomal Drug Delivery to Diverse Tumor Lesions in HER2-Positive Breast Cancer PatientsHendriks B, Shields A, Siegel B, Miller K, Munster P, Ma C, Campbell K, Moyo V, Wickham T, LoRusso P. 55P PET/CT Imaging of 64CU-Labelled HER2 Liposomal Doxorubicin (64CU-MM-302) Quantifies Variability of Liposomal Drug Delivery to Diverse Tumor Lesions in HER2-Positive Breast Cancer Patients Annals Of Oncology 2014, 25: i19. DOI: 10.1093/annonc/mdu068.1.
  • Erratum to: Phase I study of PF-04691502, a small-molecule, oral, dual inhibitor of PI3K and mTOR, in patients with advanced cancerBritten C, Adjei A, Millham R, Houk B, Borzillo G, Pierce K, Wainberg Z, LoRusso P. Erratum to: Phase I study of PF-04691502, a small-molecule, oral, dual inhibitor of PI3K and mTOR, in patients with advanced cancer Investigational New Drugs 2014, 32: 575-575. DOI: 10.1007/s10637-014-0069-6.
  • Phase I and IIa studies of simtuzumab alone and in combination with FOLFIRI in patients with advanced solid tumors.LoRusso P, Hecht J, Thai D, Hawkins M, Dong H, Tolcher A. Phase I and IIa studies of simtuzumab alone and in combination with FOLFIRI in patients with advanced solid tumors. Journal Of Clinical Oncology 2014, 32: 554-554. DOI: 10.1200/jco.2014.32.3_suppl.554.
  • Abstract P4-12-29: Assessment of safety and activity in an expanded phase 1 study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced HER2-positive (HER2+) breast cancerMunster P, Krop I, Miller K, Dhindsa N, Niyijiza C, Nielsen U, Odueyungbo A, Rajarethinam A, Marande M, Campbell K, Geretti E, Reynolds J, Hendriks B, Wickham T, Moyo V, LoRusso P. Abstract P4-12-29: Assessment of safety and activity in an expanded phase 1 study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced HER2-positive (HER2+) breast cancer Cancer Research 2013, 73: p4-12-29-p4-12-29. DOI: 10.1158/0008-5472.sabcs13-p4-12-29.
  • Abstract A120: A Phase Ib study of CC-486 (Oral Azacitidine) as a priming agent for carboplatin or NAB-paclitaxel in subjects with relapsed and refractory solid tumors.LoRusso P, Rasco D, Bendell J, Sachdev J, Ramanathan R, Weiss G, Munster P, Edenfield W, Liu K, Blackwood-Chirchir A, DiMartino J, DiMartino J, Von Hoff D. Abstract A120: A Phase Ib study of CC-486 (Oral Azacitidine) as a priming agent for carboplatin or NAB-paclitaxel in subjects with relapsed and refractory solid tumors. Molecular Cancer Therapeutics 2013, 12: a120-a120. DOI: 10.1158/1535-7163.targ-13-a120.
  • Abstract A218: Pharmacokinetics of orally administered rucaparib in patients with advanced solid tumors.Shapiro G, Kristeleit R, Middleton M, Burris H, Molife L, Evans J, Wilson R, LoRusso P, Spicer J, Dieras V, Patel M, Dominy E, Simpson D, Giordano H, Allen A, Jaw-Tsai S, Plummer R. Abstract A218: Pharmacokinetics of orally administered rucaparib in patients with advanced solid tumors. Molecular Cancer Therapeutics 2013, 12: a218-a218. DOI: 10.1158/1535-7163.targ-13-a218.
  • Abstract B187: Pharmacodynamics of OSI-027, a dual mTORC1/mTORC2 inhibitor, in tumor and surrogate tissues: Results from the expansion phase of a first-in-man study.Mateo J, Schoffski P, Olmos D, Dumez H, Moreno V, Jie F, Poondru S, Samberg N, Van Tornout J, Kaye S, LoRusso P. Abstract B187: Pharmacodynamics of OSI-027, a dual mTORC1/mTORC2 inhibitor, in tumor and surrogate tissues: Results from the expansion phase of a first-in-man study. Molecular Cancer Therapeutics 2013, 12: b187-b187. DOI: 10.1158/1535-7163.targ-13-b187.
  • Abstract B217: A Phase I study of CC-486 (oral azacitidine) to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of azacitidine administered alone and in combination with carboplatin or ABI-007 (NAB-paclitaxel) in subjects with solid tumors.Laille E, Nguyen A, Chen G, Rasco D, LoRusso P, Von Hoff D, Bendell J, Munster P, Edenfield W, Ramanathan R, Gonzalez M, Blackwood-Chirchir A, DiMartino J. Abstract B217: A Phase I study of CC-486 (oral azacitidine) to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of azacitidine administered alone and in combination with carboplatin or ABI-007 (NAB-paclitaxel) in subjects with solid tumors. Molecular Cancer Therapeutics 2013, 12: b217-b217. DOI: 10.1158/1535-7163.targ-13-b217.
  • Abstract B48: A first-in-human Phase I study of the novel cancer stem cell (CSC) targeting antibody OMP-52M51 (anti-Notch1) administered intravenously to patients with certain advanced solid tumors.Davis S, LoRusso P, Xu L, Kapoun A, Dupont J, Munster P, Eckhardt S, Patnaik A. Abstract B48: A first-in-human Phase I study of the novel cancer stem cell (CSC) targeting antibody OMP-52M51 (anti-Notch1) administered intravenously to patients with certain advanced solid tumors. Molecular Cancer Therapeutics 2013, 12: b48-b48. DOI: 10.1158/1535-7163.targ-13-b48.
  • Trastuzumab emtansine (T-DM1) in previously treated HER2-positive metastatic breast cancer (MBC): Results from an expanded access study.Yardley D, Krop I, LoRusso P, Robert N, Mayer M, Abidoye O, Lai C, Yoo B, Perez E. Trastuzumab emtansine (T-DM1) in previously treated HER2-positive metastatic breast cancer (MBC): Results from an expanded access study. Journal Of Clinical Oncology 2013, 31: 166-166. DOI: 10.1200/jco.2013.31.26_suppl.166.
  • Clinical and pharmacodynamic (PD) results of a phase I trial with AMP-224 (B7-DC Fc) that binds to the PD-1 receptor.Infante J, Powderly J, Burris H, Kittaneh M, Grice J, Smothers J, Brett S, Fleming M, May R, Marshall S, Devenport M, Pillemer S, Pardoll D, Chen L, Langermann S, LoRusso P. Clinical and pharmacodynamic (PD) results of a phase I trial with AMP-224 (B7-DC Fc) that binds to the PD-1 receptor. Journal Of Clinical Oncology 2013, 31: 3044-3044. DOI: 10.1200/jco.2013.31.15_suppl.3044.
  • Phase I study of REGN421 (R)/SAR153192, a fully-human delta-like ligand 4 (Dll4) monoclonal antibody (mAb), in patients with advanced solid tumors.Jimeno A, LoRusso P, Strother R, Diamond J, Plato L, Younger A, Messersmith W, Kittaneh M, Sawyer D, Adriaens L, Liu L, Kao R, DiCioccio A, Brownstein C, Lowy I, Trail P, Chiorean E. Phase I study of REGN421 (R)/SAR153192, a fully-human delta-like ligand 4 (Dll4) monoclonal antibody (mAb), in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2502-2502. DOI: 10.1200/jco.2013.31.15_suppl.2502.
  • A phase I study of birinapant (TL32711) combined with multiple chemotherapies evaluating tolerability and clinical activity for solid tumor patients.Amaravadi R, Senzer N, Martin L, Schilder R, LoRusso P, Papadopoulos K, Weng D, Graham M, Adjei A. A phase I study of birinapant (TL32711) combined with multiple chemotherapies evaluating tolerability and clinical activity for solid tumor patients. Journal Of Clinical Oncology 2013, 31: 2504-2504. DOI: 10.1200/jco.2013.31.15_suppl.2504.
  • Predictive value of phase I trials for safety and final approved dose in later trials: Analysis of 33,845 patients.Fontes Jardim D, Hess K, LoRusso P, Kurzrock R, Hong D. Predictive value of phase I trials for safety and final approved dose in later trials: Analysis of 33,845 patients. Journal Of Clinical Oncology 2013, 31: 2509-2509. DOI: 10.1200/jco.2013.31.15_suppl.2509.
  • Phase I, first-in-human, open-label, dose-escalation study of U3-1565, a fully human anti-HB-EGF monoclonal antibody, in patients with advanced solid tumors.Moore K, Bendell J, Olszanski A, Desai M, Jansen M, Scheyer R, Senaldi G, LoRusso P. Phase I, first-in-human, open-label, dose-escalation study of U3-1565, a fully human anti-HB-EGF monoclonal antibody, in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2519-2519. DOI: 10.1200/jco.2013.31.15_suppl.2519.
  • Phase I, dose-escalation study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced solid tumors.Adjei A, LoRusso P, Ribas A, Sosman J, Pavlick A, Dy G, Zhou X, Gangolli E, Walker R, Kneissl M, Faucette S, Neuwirth R, Bozon V. Phase I, dose-escalation study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2528-2528. DOI: 10.1200/jco.2013.31.15_suppl.2528.
  • A phase I, first-in-human study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of IMGN853 in patients (Pts) with epithelial ovarian cancer (EOC) and other FOLR1-positive solid tumors.Kurkjian C, LoRusso P, Sankhala K, Birrer M, Kirby M, Ladd S, Hawes S, Running K, O'Leary J, Moore K. A phase I, first-in-human study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of IMGN853 in patients (Pts) with epithelial ovarian cancer (EOC) and other FOLR1-positive solid tumors. Journal Of Clinical Oncology 2013, 31: 2573-2573. DOI: 10.1200/jco.2013.31.15_suppl.2573.
  • A phase I dose-escalation and PK study of continuous oral rucaparib in patients with advanced solid tumors.Kristeleit R, Shapiro G, LoRusso P, Infante J, Flynn M, Patel M, Tolaney S, Hilton J, Calvert A, Giordano H, Isaacson J, Borrow J, Allen A, Jaw-Tsai S, Burris H. A phase I dose-escalation and PK study of continuous oral rucaparib in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2585-2585. DOI: 10.1200/jco.2013.31.15_suppl.2585.
  • Pharmacokinetics and safety of an oral ALK inhibitor, ASP3026, observed in a phase I dose escalation trial.Patnaik A, LoRusso P, Ball H, Bahceci E, Yuen G, Papadopoulos K, Kittaneh M, Tolcher A. Pharmacokinetics and safety of an oral ALK inhibitor, ASP3026, observed in a phase I dose escalation trial. Journal Of Clinical Oncology 2013, 31: 2602-2602. DOI: 10.1200/jco.2013.31.15_suppl.2602.
  • Phase II clinical activity and tolerability of the SMAC-mimetic birinapant (TL32711) plus irinotecan in irinotecan-relapsed/refractory metastatic colorectal cancer.Senzer N, LoRusso P, Martin L, Schilder R, Amaravadi R, Papadopoulos K, Segota Z, Weng D, Graham M, Adjei A. Phase II clinical activity and tolerability of the SMAC-mimetic birinapant (TL32711) plus irinotecan in irinotecan-relapsed/refractory metastatic colorectal cancer. Journal Of Clinical Oncology 2013, 31: 3621-3621. DOI: 10.1200/jco.2013.31.15_suppl.3621.
  • A phase II study of suberoylanilide hydroxamic acid (SAHA) in subjects with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC).Goncalves P, Kummar S, Siu L, Hansen A, Savvides P, Sukari A, Chao J, Heilbrun L, Pilat M, Smith D, Casetta L, Boerner S, LoRusso P. A phase II study of suberoylanilide hydroxamic acid (SAHA) in subjects with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC). Journal Of Clinical Oncology 2013, 31: 6045-6045. DOI: 10.1200/jco.2013.31.15_suppl.6045.
  • Abstract LB-193: Phase I study of safety, tolerability, pharmacokinetics, and pharmacodynamics of AMP-224 (B7-DC Fc fusion protein) in a regimen containing cyclophosphamide (CTX) in patients with advanced solid tumors.LoRusso P, Powderly J, Burris H, Kittaneh M, Grice J, Smothers J, Brett S, Fleming M, May R, Marshall S, Devenport M, Pillemer S, Pardoll D, Chen L, Langermann S, Infante J. Abstract LB-193: Phase I study of safety, tolerability, pharmacokinetics, and pharmacodynamics of AMP-224 (B7-DC Fc fusion protein) in a regimen containing cyclophosphamide (CTX) in patients with advanced solid tumors. Cancer Research 2013, 73: lb-193-lb-193. DOI: 10.1158/1538-7445.am2013-lb-193.
  • Abstract 2023: Whole exome and RNA sequencing reveals genetic alterations in DNA damage and homologous recombination pathways in triple negative breast cancer.Wong S, O'Shaughnessy J, LoRusso P, Aldrich J, Kurdoglu A, Christoforides A, Dinh J, Izatt T, Sinari S, Baker A, Moses T, Salhia B, Mousses S, Kiefer J, Trent J, Von Hoff D, Shapiro G, Liang W, Craig D, Carpten J. Abstract 2023: Whole exome and RNA sequencing reveals genetic alterations in DNA damage and homologous recombination pathways in triple negative breast cancer. Cancer Research 2013, 73: 2023-2023. DOI: 10.1158/1538-7445.am2013-2023.
  • Abstract 3375: Phase 1 pharmacodyamic activity of multiple-dose PEGylated hyaluronidase PH20 (PEGPH20) in patients with solid tumors.Jiang P, Maneval D, Ramanathan R, Infante J, Borad M, Bessudo A, LoRusso P, Sugarman B, Carson D, Printz M, Thompson C, Selvam P, Zhu J, Korn R, Shepard H, Frost G. Abstract 3375: Phase 1 pharmacodyamic activity of multiple-dose PEGylated hyaluronidase PH20 (PEGPH20) in patients with solid tumors. Cancer Research 2013, 73: 3375-3375. DOI: 10.1158/1538-7445.am2013-3375.
  • Abstract LB-203: A phase I study of BIND-014, a PSMA-targeted nanoparticle containing docetaxel, in patients with refractory solid tumors.Von Hoff D, Mita M, Eisenberg P, LoRusso P, Weiss G, Sachdev J, Mita A, Low S, Hrkach J, Summa J, Berk G, Ramanathan R. Abstract LB-203: A phase I study of BIND-014, a PSMA-targeted nanoparticle containing docetaxel, in patients with refractory solid tumors. Cancer Research 2013, 73: lb-203-lb-203. DOI: 10.1158/1538-7445.am2013-lb-203.
  • 588 A First-in-patient Phase I Study of the Novel Gamma Secretase Inhibitor PF-03084014 in Patients with Advanced Solid Tumor MalignanciesMessersmith W, LoRusso P, Cleary J, Dasari A, Huang B, Shaik N, Cesari R, McLachlan K, Kern K, Shapiro G. 588 A First-in-patient Phase I Study of the Novel Gamma Secretase Inhibitor PF-03084014 in Patients with Advanced Solid Tumor Malignancies European Journal Of Cancer 2012, 48: 180. DOI: 10.1016/s0959-8049(12)72385-7.
  • 609 A Phase 1 Study of MEDI-573, an Investigational Monoclonal Antibody That Targets IGF-I and IGF-II: Safety, Pharmacokinetics, and Antitumor Activity in Adults with Advanced Solid TumorsHaluska P, Menefee M, Plimack E, Rosenberg J, Northfelt D, LaVallee T, Huang W, Yu X, Viner J, LoRusso P. 609 A Phase 1 Study of MEDI-573, an Investigational Monoclonal Antibody That Targets IGF-I and IGF-II: Safety, Pharmacokinetics, and Antitumor Activity in Adults with Advanced Solid Tumors European Journal Of Cancer 2012, 48: 187-188. DOI: 10.1016/s0959-8049(12)72406-1.
  • 456P Multicenter, Dose-Escalation Study of the Investigational Drug Tak-733, An Oral Mek inhibitor, in Patients (PTS) with Advanced Solid Tumors: Preliminary Phase 1 ResultsAdjei A, LoRusso P, Ribas A, Sosman J, Dy G, Chmielowski B, Lipman P, Zhou X, Gangolli E, Bozón V. 456P Multicenter, Dose-Escalation Study of the Investigational Drug Tak-733, An Oral Mek inhibitor, in Patients (PTS) with Advanced Solid Tumors: Preliminary Phase 1 Results Annals Of Oncology 2012, 23: ix158. DOI: 10.1016/s0923-7534(20)33014-3.
  • 497P Dose-Escalation Phase I Study of Cabazitaxel (CBZ) + Gemcitabine (GEM) in Patients (PTS) with Metastatic or Unresectable Advanced Solid MalignancyRixe O, Puzanov I, LoRusso P, Yin J, Doroumian S, Zhi X, Olszanski A. 497P Dose-Escalation Phase I Study of Cabazitaxel (CBZ) + Gemcitabine (GEM) in Patients (PTS) with Metastatic or Unresectable Advanced Solid Malignancy Annals Of Oncology 2012, 23: ix170. DOI: 10.1016/s0923-7534(20)33059-3.
  • 507 Phase I, Open-Label, Randomized, Crossover Study Evaluating the Effects of Linifanib on Qtc Intervals in Patients with Solid TumorsChiu Y, LoRusso P, Ricker J, Li X, Pradhan R, Carlson D. 507 Phase I, Open-Label, Randomized, Crossover Study Evaluating the Effects of Linifanib on Qtc Intervals in Patients with Solid Tumors Annals Of Oncology 2012, 23: ix173. DOI: 10.1016/s0923-7534(20)33069-6.
  • 1111PD Expanded Access Study of Advanced Bcc Patients Treated with the Hedgehog-Pathway Inhibitor VismodegibWeiss G, Oro A, Chang A, Solomon J, LoRusso P, Hamid O, Chen D, McKenna E, Feng S, Hainsworth J. 1111PD Expanded Access Study of Advanced Bcc Patients Treated with the Hedgehog-Pathway Inhibitor Vismodegib Annals Of Oncology 2012, 23: ix362. DOI: 10.1016/s0923-7534(20)33683-8.
  • Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab.Modi S, Elias A, LoRusso P, Samant M, Guardino E, Althaus B, Krop I. Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab. Journal Of Clinical Oncology 2012, 30: 528-528. DOI: 10.1200/jco.2012.30.15_suppl.528.
  • A phase I study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced, HER2-positive (HER2+) breast cancer.Munster P, Miller K, Krop I, Dhindsa N, Reynolds J, Geretti E, Niyikiza C, Nielsen U, Hendriks B, Wickham T, Moyo V, LoRusso P. A phase I study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced, HER2-positive (HER2+) breast cancer. Journal Of Clinical Oncology 2012, 30: tps663-tps663. DOI: 10.1200/jco.2012.30.15_suppl.tps663.
  • A first-in-human, phase I safety and pharmacokinetic study of genz-644282, a non-camptothecin topoisomerase I inhibitor, in patients with advanced solid tumors.Han H, Tan A, Weiss G, Sullivan D, Strosberg J, Collins S, Moss R, Wu J, Ewesuedo R, LoRusso P. A first-in-human, phase I safety and pharmacokinetic study of genz-644282, a non-camptothecin topoisomerase I inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 2534-2534. DOI: 10.1200/jco.2012.30.15_suppl.2534.
  • A first-in-human phase Ib study to evaluate the MEK inhibitor GDC-0973, combined with the pan-PI3K inhibitor GDC-0941, in patients with advanced solid tumors.LoRusso P, Shapiro G, Pandya S, Kwak E, Jones C, Belvin M, Musib L, de Crespigny A, McKenzie M, Gates M, Chan I, Bendell J. A first-in-human phase Ib study to evaluate the MEK inhibitor GDC-0973, combined with the pan-PI3K inhibitor GDC-0941, in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 2566-2566. DOI: 10.1200/jco.2012.30.15_suppl.2566.
  • Targeting hyaluronan (HA) in tumor stroma: A phase I study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of pegylated hyaluronidase (PEGPH20) in patients with solid tumors.Borad M, Ramanathan R, Bessudo A, LoRusso P, Shepard H, Maneval D, Jiang P, Zhu J, Frost G, Infante J. Targeting hyaluronan (HA) in tumor stroma: A phase I study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of pegylated hyaluronidase (PEGPH20) in patients with solid tumors. Journal Of Clinical Oncology 2012, 30: 2579-2579. DOI: 10.1200/jco.2012.30.15_suppl.2579.
  • Clinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens.Fetterly G, Liu B, Senzer N, Amaravadi R, Schilder R, Martin L, LoRusso P, Papadopoulos K, Adjei A, Zagst P, McKinlay M, Weng D, Graham M. Clinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens. Journal Of Clinical Oncology 2012, 30: 3029-3029. DOI: 10.1200/jco.2012.30.15_suppl.3029.
  • Phase Ib study of CNTO 888 (anti-CCL 2) in combination with chemotherapies for treatment of patients with solid tumors.Calles A, Brana I, LoRusso P, Yee L, Puchalski T, Seetharam S, Balvers M, De Boer C, Elsayed Y, Calvo E, Tabernero J. Phase Ib study of CNTO 888 (anti-CCL 2) in combination with chemotherapies for treatment of patients with solid tumors. Journal Of Clinical Oncology 2012, 30: 3059-3059. DOI: 10.1200/jco.2012.30.15_suppl.3059.
  • Open-label extension study of the RNAi therapeutic ALN-VSP02 in cancer patients responding to therapy.Alsina M, Tabernero J, Shapiro G, Burris H, Infante J, Weiss G, Cervantes-Ruiperez A, Gounder M, Paz-Ares L, Falzone R, Hill J, Cehelsky J, Vaishnaw A, Gollob J, LoRusso P. Open-label extension study of the RNAi therapeutic ALN-VSP02 in cancer patients responding to therapy. Journal Of Clinical Oncology 2012, 30: 3062-3062. DOI: 10.1200/jco.2012.30.15_suppl.3062.
  • Activity of insulin growth factor-receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic refractory adrenocortical carcinoma.Naing A, LoRusso P, Fu S, Hong D, Chen H, Doyle L, Phan A, Habra M, Kurzrock R. Activity of insulin growth factor-receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic refractory adrenocortical carcinoma. Journal Of Clinical Oncology 2012, 30: 4639-4639. DOI: 10.1200/jco.2012.30.15_suppl.4639.
  • Safety, pharmacokinetics, and antitumor activity of MEDI-573, an investigational monoclonal antibody that targets IGF-I and IGF-II, in adult patients with advanced solid tumors.Haluska P, Menefee M, Plimack E, Rosenberg J, Northfelt D, LaVallee T, Huang W, Yu X, Viner J, LoRusso P. Safety, pharmacokinetics, and antitumor activity of MEDI-573, an investigational monoclonal antibody that targets IGF-I and IGF-II, in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: tps2618-tps2618. DOI: 10.1200/jco.2012.30.15_suppl.tps2618.
  • MDV3100-08: A phase I open-label, dose-escalation study evaluating the safety, tolerability, and pharmacokinetics of MDV3100 in women with incurable breast cancer.Elias A, Richer J, LoRusso P, Peterson A, Steinberg J, Mordenti J, Lopez C, Hudis C, Traina T. MDV3100-08: A phase I open-label, dose-escalation study evaluating the safety, tolerability, and pharmacokinetics of MDV3100 in women with incurable breast cancer. Journal Of Clinical Oncology 2012, 30: tps668-tps668. DOI: 10.1200/jco.2012.30.15_suppl.tps668.
  • Oral Chemotherapeutic AgentsOgita S, LoRusso P, Li J. Oral Chemotherapeutic Agents 2012, 1-37. DOI: 10.1002/9780470921920.edm132.
  • Abstract 3766: Effects of a high-fat meal on the pharmacokinetics of orally administered GSK2118436 in patients with BRAF mutation-positive tumorsGrossmann K, Infante J, LoRusso P, Sharma S, Blackman S, Carson S, Krachey E, Nebot N, Ouellet D, Gordon M. Abstract 3766: Effects of a high-fat meal on the pharmacokinetics of orally administered GSK2118436 in patients with BRAF mutation-positive tumors Cancer Research 2012, 72: 3766-3766. DOI: 10.1158/1538-7445.am2012-3766.
  • Abstract LB-122: A phase I dose escalation study of NVP-BGJ398, a selective pan FGFR inhibitor in genetically preselected advanced solid tumorsWolf J, LoRusso P, Camidge R, Perez J, Tabernero J, Hidalgo M, Schuler M, Tian G, Soria J, Delord J, Campone M, Bachelot T, van der Noll R, Ringeisen F, Nogova L, Sequist L, Schellens J. Abstract LB-122: A phase I dose escalation study of NVP-BGJ398, a selective pan FGFR inhibitor in genetically preselected advanced solid tumors Cancer Research 2012, 72: lb-122-lb-122. DOI: 10.1158/1538-7445.am2012-lb-122.
  • Abstract LB-124: Insulin growth factor-receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with refractory Ewing's sarcoma family tumorsNaing A, LoRusso P, Subbiah V, Fu S, Hong D, Anderson P, Benjamin R, Ludwig J, Chen H, Doyle A, Kurzrock R. Abstract LB-124: Insulin growth factor-receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with refractory Ewing's sarcoma family tumors Cancer Research 2012, 72: lb-124-lb-124. DOI: 10.1158/1538-7445.am2012-lb-124.
  • Abstract LB-452: A phase I, open label, safety, pharmacokinetic and pharmacodynamic dose escalation study of BIND-014 given by IV infusion to patients with advanced or metastatic cancerSumma J, LoRusso P, Eisenberg P, Hrkach J, Schnipper E, Hoff D. Abstract LB-452: A phase I, open label, safety, pharmacokinetic and pharmacodynamic dose escalation study of BIND-014 given by IV infusion to patients with advanced or metastatic cancer Cancer Research 2012, 72: lb-452-lb-452. DOI: 10.1158/1538-7445.am2012-lb-452.
  • Reply to E.S. Wang et alLoRusso P, Boerner S, Evelhoch J, Evelhoch J. Reply to E.S. Wang et al Journal Of Clinical Oncology 2012, 30: 762-763. DOI: 10.1200/jco.2011.39.6895.
  • C-MET as a Novel Target for the Treatment of Renal Cell CarcinomaVankayala H, LoRusso P, Vaishampayan U. C-MET as a Novel Target for the Treatment of Renal Cell Carcinoma 2012, 213-238. DOI: 10.1007/978-1-4614-2400-0_10.
  • Abstract A25: Phase 1 PK/PD analysis of the Smac-mimetic TL32711 demonstrates potent and sustained cIAP1 suppression in patient PBMCs and tumor biopsies.Graham M, Mitsuuchi Y, Burns J, Chunduru S, Benetatos C, McKinlay M, Weng D, Wick M, Tolcher A, Papadopoulos K, Amaravadi R, Schilder R, Adjei A, LoRusso P. Abstract A25: Phase 1 PK/PD analysis of the Smac-mimetic TL32711 demonstrates potent and sustained cIAP1 suppression in patient PBMCs and tumor biopsies. Molecular Cancer Therapeutics 2011, 10: a25-a25. DOI: 10.1158/1535-7163.targ-11-a25.
  • Abstract A93: Safety, efficacy and pharmacokinetics of two schedules of navitoclax (ABT-263) in combination with irinotecan: Preliminary results of an open-label phase 1 study.Tolcher A, LoRusso P, Rosen L, de Oliveira M, Waring J, Rudersdorf N, Patel R, Brasher C, Busman T, Cui Y, Yang J, Holen K. Abstract A93: Safety, efficacy and pharmacokinetics of two schedules of navitoclax (ABT-263) in combination with irinotecan: Preliminary results of an open-label phase 1 study. Molecular Cancer Therapeutics 2011, 10: a93-a93. DOI: 10.1158/1535-7163.targ-11-a93.
  • Abstract A95: The determination of the maximum tolerated dose (MTD) of MGCD265 on an intermittent schedule: Phase I study results (Study 265-102).Wheler J, Kurzrock R, Heath E, Falchook G, Maroun C, Drouin M, Juretic M, Bonfils C, Karam A, Besterman J, Wang J, LoRusso P. Abstract A95: The determination of the maximum tolerated dose (MTD) of MGCD265 on an intermittent schedule: Phase I study results (Study 265-102). Molecular Cancer Therapeutics 2011, 10: a95-a95. DOI: 10.1158/1535-7163.targ-11-a95.
  • Abstract B163: First-in-patient study of PF-04691502, a small molecule intravenous dual inhibitor of PI3K and mTOR in patients with advanced cancer: Update on safety, efficacy, and pharmacology.Millham R, Houk B, Borzillo G, LoRusso P, Marburg L, Britten C, Wainberg Z, Adjei A, Dy G. Abstract B163: First-in-patient study of PF-04691502, a small molecule intravenous dual inhibitor of PI3K and mTOR in patients with advanced cancer: Update on safety, efficacy, and pharmacology. Molecular Cancer Therapeutics 2011, 10: b163-b163. DOI: 10.1158/1535-7163.targ-11-b163.
  • Abstract B188: Pharmacokinetic assessment of drug-drug interaction potential when rosiglitazone or combined oral contraceptive is coadministered with vismodegib in patients with locally advanced or metastatic solid tumors.LoRusso P, Piha-Paul S, Colevas A, Malhi V, Colburn D, Yin M, Low J, Graham R. Abstract B188: Pharmacokinetic assessment of drug-drug interaction potential when rosiglitazone or combined oral contraceptive is coadministered with vismodegib in patients with locally advanced or metastatic solid tumors. Molecular Cancer Therapeutics 2011, 10: b188-b188. DOI: 10.1158/1535-7163.targ-11-b188.
  • Abstract B225: A phase I dose-escalation study of selumetinib in combination with docetaxel in patients with advanced solid tumors.Kim K, Infante J, Cohen R, Burris H, Emeribe U, Curt G, Clemett D, LoRusso P. Abstract B225: A phase I dose-escalation study of selumetinib in combination with docetaxel in patients with advanced solid tumors. Molecular Cancer Therapeutics 2011, 10: b225-b225. DOI: 10.1158/1535-7163.targ-11-b225.
  • MEDI-573 as a novel approach to IGF-1R and IR-A signaling inhibition by blocking IGF ligands: Phase I PK/PD, safety data, and disease linkage studies in breast cancer.Haluska P, Huang J, Lam B, Liang M, Huang W, LoRusso P, Menefee M, LaVallee T, Yao Y, Viner J. MEDI-573 as a novel approach to IGF-1R and IR-A signaling inhibition by blocking IGF ligands: Phase I PK/PD, safety data, and disease linkage studies in breast cancer. Journal Of Clinical Oncology 2011, 29: 271-271. DOI: 10.1200/jco.2011.29.27_suppl.271.
  • Cixutumumab combined with temsirolimus in patients with refractory Ewing’s sarcoma.Naing A, LoRusso P, Fu S, Hong D, Anderson P, Benjamin R, Ludwig J, Chen H, Doyle L, Kurzrock R. Cixutumumab combined with temsirolimus in patients with refractory Ewing’s sarcoma. Journal Of Clinical Oncology 2011, 29: 10031-10031. DOI: 10.1200/jco.2011.29.15_suppl.10031.
  • The role of GDC-0449, a hedgehog (Hh) pathway inhibitor, on epithelial–mesenchymal transition (EMT) in non-small cell lung cancer (NSCLC) cells lines and its effect on erlotinib and cisplatin.Maitah M, Ali S, LoRusso P, Sarkar F, Gadgeel S. The role of GDC-0449, a hedgehog (Hh) pathway inhibitor, on epithelial–mesenchymal transition (EMT) in non-small cell lung cancer (NSCLC) cells lines and its effect on erlotinib and cisplatin. Journal Of Clinical Oncology 2011, 29: 10537-10537. DOI: 10.1200/jco.2011.29.15_suppl.10537.
  • Progression-free survival (PFS) from a phase I study of crizotinib (PF-02341066) in patients with ALK- positive non-small cell lung cancer (NSCLC).Camidge D, Bang Y, Kwak E, Shaw A, Iafrate A, Maki R, Solomon B, Ou S, Salgia R, Wilner K, Costa D, Shapiro G, LoRusso P, Stephenson P, Tang Y, Ruffner K, Clark J. Progression-free survival (PFS) from a phase I study of crizotinib (PF-02341066) in patients with ALK- positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2011, 29: 2501-2501. DOI: 10.1200/jco.2011.29.15_suppl.2501.
  • Phase I study of TAK-285, an investigational HER2/EGFR inhibitor, in patients (pts) with advanced cancer: Updated results and assessment of human CSF distribution.Chiorean E, Sausville E, Heath E, Weise A, Gomez-Navarro J, Venkatakrishnan K, Sankoh S, Wu J, Corvez M, LoRusso P. Phase I study of TAK-285, an investigational HER2/EGFR inhibitor, in patients (pts) with advanced cancer: Updated results and assessment of human CSF distribution. Journal Of Clinical Oncology 2011, 29: 2538-2538. DOI: 10.1200/jco.2011.29.15_suppl.2538.
  • Phase I study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the poly(ADP-ribose) polymerase (PARP) inhibitor veliparib (ABT-888; V) in combination with irinotecan (CPT-11; Ir) in patients (pts) with advanced solid tumors.LoRusso P, Ji J, Li J, Heilbrun L, Shapiro G, Sausville E, Boerner S, Smith D, Pilat M, Zhang J, Chen A, Nechiporchik N, Parchment R. Phase I study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the poly(ADP-ribose) polymerase (PARP) inhibitor veliparib (ABT-888; V) in combination with irinotecan (CPT-11; Ir) in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3000-3000. DOI: 10.1200/jco.2011.29.15_suppl.3000.
  • Clinical combination of the MEK inhibitor GDC-0973 and the PI3K inhibitor GDC-0941: A first-in-human phase Ib study testing daily and intermittent dosing schedules in patients with advanced solid tumors.Shapiro G, LoRusso P, Kwak E, Cleary J, Musib L, Jones C, de Crespigny A, Belvin M, McKenzie M, Gates M, Chan I, Bendell J. Clinical combination of the MEK inhibitor GDC-0973 and the PI3K inhibitor GDC-0941: A first-in-human phase Ib study testing daily and intermittent dosing schedules in patients with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3005-3005. DOI: 10.1200/jco.2011.29.15_suppl.3005.
  • Phase I dose-escalation study of ALN-VSP02, a novel RNAi therapeutic for solid tumors with liver involvement.Cervantes A, Alsina M, Tabernero J, Infante J, LoRusso P, Shapiro G, Paz-Ares L, Falzone R, Hill J, Cehelsky J, White A, Toudjarska I, Bumcrot D, Meyers R, Hinkle G, Svrzikapa N, Sah D, Vaishnaw A, Gollob J, Burris H. Phase I dose-escalation study of ALN-VSP02, a novel RNAi therapeutic for solid tumors with liver involvement. Journal Of Clinical Oncology 2011, 29: 3025-3025. DOI: 10.1200/jco.2011.29.15_suppl.3025.
  • A first-in-human phase I study of U3-1287 (AMG 888), a HER3 inhibitor, in patients (pts) with advanced solid tumors.Berlin J, Keedy V, Janne P, Yee L, Rizvi N, Jin X, Copigneaux C, Hettmann T, Beaupre D, LoRusso P. A first-in-human phase I study of U3-1287 (AMG 888), a HER3 inhibitor, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3026-3026. DOI: 10.1200/jco.2011.29.15_suppl.3026.
  • A phase Ib study for MNRP1685A (anti-NRP1) administered intravenously with bevacizumab with or without paclitaxel to patients with advanced solid tumors.Weekes C, LoRusso P, Ramakrishnan V, Shih L, Darbonne W, Hegde P, Xin Y, Yu R, Xiang H, Brachmann R, Patnaik A. A phase Ib study for MNRP1685A (anti-NRP1) administered intravenously with bevacizumab with or without paclitaxel to patients with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3050-3050. DOI: 10.1200/jco.2011.29.15_suppl.3050.
  • A phase I dose-escalation study of the Hsp90 inhibitor ganetespib (STA-9090) administered twice weekly in patients with solid tumors: Updated report.Cho D, Heath E, Cleary J, Kwak E, Gandhi L, Lawrence D, Zack C, Teofilovici F, Bradley R, Karol M, Shapiro G, LoRusso P. A phase I dose-escalation study of the Hsp90 inhibitor ganetespib (STA-9090) administered twice weekly in patients with solid tumors: Updated report. Journal Of Clinical Oncology 2011, 29: 3051-3051. DOI: 10.1200/jco.2011.29.15_suppl.3051.
  • A phase I dose-escalation study to evaluate GDC-0941, a pan-PI3K inhibitor, administered QD or BID in patients with advanced or metastatic solid tumors.Von Hoff D, LoRusso P, Demetri G, Weiss G, Shapiro G, Ramanathan R, Ware J, Raja R, Jin J, Levy G, Mazina K, Wagner A. A phase I dose-escalation study to evaluate GDC-0941, a pan-PI3K inhibitor, administered QD or BID in patients with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2011, 29: 3052-3052. DOI: 10.1200/jco.2011.29.15_suppl.3052.
  • Phase I dose-escalation study of AZD7762 in combination with gemcitabine (gem) in patients (pts) with advanced solid tumors.Sausville E, LoRusso P, Carducci M, Barker P, Agbo F, Oakes P, Senderowicz A. Phase I dose-escalation study of AZD7762 in combination with gemcitabine (gem) in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3058-3058. DOI: 10.1200/jco.2011.29.15_suppl.3058.
  • Phase I pharmacokinetic study of temsirolimus (CCI-779) in patients with advanced malignancies and normal and impaired liver function: An NCI Organ Dysfunction Working Group (ODWG) study.Sarantopoulos J, Lenz H, LoRusso P, Shibata S, Kummar S, Mulkerin D, Ramanathan R, Mita M, O'Rourke P, Remick S, Goel S, Gutierrez M, Ramalingam S, Murgo A, Davies A, Mani S, Boni J, Shapiro M, Ivy S, Takimoto C. Phase I pharmacokinetic study of temsirolimus (CCI-779) in patients with advanced malignancies and normal and impaired liver function: An NCI Organ Dysfunction Working Group (ODWG) study. Journal Of Clinical Oncology 2011, 29: 3072-3072. DOI: 10.1200/jco.2011.29.15_suppl.3072.
  • Open-label, sequential, ascending, multi-dose, phase I study of KW-2450 as monotherapy in subjects with previously treated advanced solid tumors.Dickson M, LoRusso P, Sausville E, Rao N, Kobayashi E, Kurman M, Akinaga S, Schwartz G. Open-label, sequential, ascending, multi-dose, phase I study of KW-2450 as monotherapy in subjects with previously treated advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3078-3078. DOI: 10.1200/jco.2011.29.15_suppl.3078.
  • A phase I dose-escalation study of the novel gamma secretase inhibitor PF-03084014 in patients (pts) with advanced solid tumors.Messersmith W, LoRusso P, Cleary J, Dasari A, Zhang X, Shaik M, Courtney R, Randolph S, Shapiro G. A phase I dose-escalation study of the novel gamma secretase inhibitor PF-03084014 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3100-3100. DOI: 10.1200/jco.2011.29.15_suppl.3100.
  • Cediranib, a VEGF receptor 1, 2, and 3 inhibitor, and pemetrexed in patients (pts) with recurrent non-small cell lung cancer (NSCLC).Gadgeel S, Ruckdeschel J, Wozniak A, Chen W, Hackstock D, Galasso C, Burger A, Ivy S, LoRusso P, Edelman M. Cediranib, a VEGF receptor 1, 2, and 3 inhibitor, and pemetrexed in patients (pts) with recurrent non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2011, 29: 7564-7564. DOI: 10.1200/jco.2011.29.15_suppl.7564.
  • Mechanism for platelet reduction in anti-neuropilin-1 (MNRP1685A)–treated phase I patients.Darbonne W, Du X, Dhawan P, Hartley D, Tarrant J, Taylor H, Cain G, Shih L, Brachmann R, Phung Q, Weekes C, LoRusso P, Patnaik A, Xiang H, Ramakrishnan V. Mechanism for platelet reduction in anti-neuropilin-1 (MNRP1685A)–treated phase I patients. Journal Of Clinical Oncology 2011, 29: e13598-e13598. DOI: 10.1200/jco.2011.29.15_suppl.e13598.
  • First-in-human, multicenter, dose-escalation, phase I study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced nonhematologic malignancies and melanoma.Sosman J, Adjei A, LoRusso P, Michael S, Dy G, Bowditch A, Chmielowski B, Lee S, Walker R, Faucette S, Izmailova E, Bozon V, Ribas A. First-in-human, multicenter, dose-escalation, phase I study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced nonhematologic malignancies and melanoma. Journal Of Clinical Oncology 2011, 29: tps145-tps145. DOI: 10.1200/jco.2011.29.15_suppl.tps145.
  • Abstract 1280: Preclinical and Clinical Evidence for MEK Pathway Inhibition by GDC-0973 using FDG-PETWilliams S, Fredrickson J, Mckenzie M, Jones C, Gates M, Hoeflich K, LoRusso P, Rosen L, Sikic B, Ma W, Chan I, de Crespigny A. Abstract 1280: Preclinical and Clinical Evidence for MEK Pathway Inhibition by GDC-0973 using FDG-PET Cancer Research 2011, 71: 1280-1280. DOI: 10.1158/1538-7445.am2011-1280.
  • Abstract 1304: Clinical pharmacokinetics of GDC-0973, an oral MEK inhibitor, in cancer patients: data from a Phase 1 studyMusib L, Eppler S, Choo E, Deng A, Miles D, Hsu B, Rosen L, Sikic B, LoRusso P, Ma W, Goldman J, Fisher G, Weise A, Dy G, Chan I, Ware J. Abstract 1304: Clinical pharmacokinetics of GDC-0973, an oral MEK inhibitor, in cancer patients: data from a Phase 1 study Cancer Research 2011, 71: 1304-1304. DOI: 10.1158/1538-7445.am2011-1304.
  • Abstract 1310: Evaluation of optimal dosing schedule on steady-state pharmacokinetics of orally administered hedgehog pathway inhibitor GDC-0449 in cancer patientsLoRusso P, Jimeno A, Dy G, Berlin J, Leichman L, Colburn D, Chang I, Cheeti S, Jin J, Graham R. Abstract 1310: Evaluation of optimal dosing schedule on steady-state pharmacokinetics of orally administered hedgehog pathway inhibitor GDC-0449 in cancer patients Cancer Research 2011, 71: 1310-1310. DOI: 10.1158/1538-7445.am2011-1310.
  • Abstract 4716: A first-in-human phase 1 study to evaluate the MEK1/2 inhibitor GDC-0973 administered daily in patients with advanced solid tumorsRosen L, LoRusso P, Ma W, Goldman J, Weise A, Colevas A, Adjei A, Yazji S, Shen A, Johnston S, Gates M, Jones C, Musib L, De Crespigny A, Chan I, Sikic B. Abstract 4716: A first-in-human phase 1 study to evaluate the MEK1/2 inhibitor GDC-0973 administered daily in patients with advanced solid tumors Cancer Research 2011, 71: 4716-4716. DOI: 10.1158/1538-7445.am2011-4716.
  • Abstract LB-89: Clinical combination of the MEK inhibitor GDC-0973 and the PI3K inhibitor GDC-0941: A first-in-human phase Ib study in patients with advanced solid tumorsBendell J, LoRusso P, Kwak E, Pandya S, Musib L, Jones C, De Crespigny A, Belvin M, McKenzie M, Gates M, Chan I, Shapiro G. Abstract LB-89: Clinical combination of the MEK inhibitor GDC-0973 and the PI3K inhibitor GDC-0941: A first-in-human phase Ib study in patients with advanced solid tumors Cancer Research 2011, 71: lb-89-lb-89. DOI: 10.1158/1538-7445.am2011-lb-89.
  • Breast Cancer Rationally Designed TherapiesBurger A, LoRusso P. Breast Cancer Rationally Designed Therapies 2011, 537-546. DOI: 10.1007/978-3-642-16483-5_6746.
  • Abstract P3-14-10: A Dose-Escalation Study of Trastuzumab-DM1 (T-DM1), Paclitaxel (T), and Pertuzumab (P) in Patients with HER2-Positive, Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with a Trastuzumab-Containing RegimenKrop I, Modi S, Elias A, LoRusso P, Choi Y, Lu M. Abstract P3-14-10: A Dose-Escalation Study of Trastuzumab-DM1 (T-DM1), Paclitaxel (T), and Pertuzumab (P) in Patients with HER2-Positive, Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with a Trastuzumab-Containing Regimen Cancer Research 2010, 70: p3-14-10-p3-14-10. DOI: 10.1158/0008-5472.sabcs10-p3-14-10.
  • Abstract P3-14-22: Pharmacokinetics (PK) of Trastuzumab-DM1 (T-DM1) and Paclitaxel (T) in Patients with HER2-Positive Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with a Trastuzumab-Containing RegimenLu D, Krop I, Modi S, Elias A, LoRusso P, Huang J, Lu M, Girish S. Abstract P3-14-22: Pharmacokinetics (PK) of Trastuzumab-DM1 (T-DM1) and Paclitaxel (T) in Patients with HER2-Positive Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with a Trastuzumab-Containing Regimen Cancer Research 2010, 70: p3-14-22-p3-14-22. DOI: 10.1158/0008-5472.sabcs10-p3-14-22.
  • Abstract P3-14-20: Phase 1 Dose-Escalation Study of the Investigational HER2/EGFR Inhibitor TAK-285 in Patients with Advanced CancerLoRusso P, Chiorean E, Heath E, Weise A, Foley M, Olivo Y, Chi X, Corvez M, Venkatakrishnan K, Sausville E. Abstract P3-14-20: Phase 1 Dose-Escalation Study of the Investigational HER2/EGFR Inhibitor TAK-285 in Patients with Advanced Cancer Cancer Research 2010, 70: p3-14-20-p3-14-20. DOI: 10.1158/0008-5472.sabcs10-p3-14-20.
  • Pharmacokinetics and Safety of Bortezomib In Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Results of the Phase 1 National Cancer Institute Organ Dysfunction Working Group Study NCI 6432Venkatakrishnan K, Ramanathan R, Sarantopoulos J, Mulkerin D, Shibata S, Hamilton A, Dowlati A, Mani S, Rudek M, Ivy P, Takimoto C, Neuwirth R, Parasuraman S, LoRusso P. Pharmacokinetics and Safety of Bortezomib In Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Results of the Phase 1 National Cancer Institute Organ Dysfunction Working Group Study NCI 6432 Blood 2010, 116: 3975-3975. DOI: 10.1182/blood.v116.21.3975.3975.
  • 234 A phase 1, open-label, dose-finding study to assess the safety and tolerability of U3 1287 (AMG 888), a human monoclonal antibody targeting HER3 in patients with advanced solid tumorsLoRusso P, Keedy V, Yee L, Oliveira M, Rizvi N, Berlin J, Jin X, Hettmann T, Copigneaux C, Beaupre D. 234 A phase 1, open-label, dose-finding study to assess the safety and tolerability of U3 1287 (AMG 888), a human monoclonal antibody targeting HER3 in patients with advanced solid tumors European Journal Of Cancer Supplements 2010, 8: 76. DOI: 10.1016/s1359-6349(10)71939-x.
  • 363 Dose of the molecularly targeted agents (MTA) in Phase 1 trials correlates with clinical benefitGupta S, Alqwasmi A, Hunsberger S, Rubinstein L, Ivy P, Royds R, LoRusso P. 363 Dose of the molecularly targeted agents (MTA) in Phase 1 trials correlates with clinical benefit European Journal Of Cancer Supplements 2010, 8: 115. DOI: 10.1016/s1359-6349(10)72070-x.
  • 82 Pharmacokinetic–pharmacodynamic modeling of the effect of GDC-0152, a selective antagonist of the inhibitor of apoptosis (IAP) proteins, on monocyte chemotactic protein-1 (MCP-1) indicates species differences in MCP-1 responseFairbrother W, Wong H, Budha N, Blackwood B, Gould S, Erickson R, LoRusso P, Eckhardt S, Wagner A, Chan I. 82 Pharmacokinetic–pharmacodynamic modeling of the effect of GDC-0152, a selective antagonist of the inhibitor of apoptosis (IAP) proteins, on monocyte chemotactic protein-1 (MCP-1) indicates species differences in MCP-1 response European Journal Of Cancer Supplements 2010, 8: 34. DOI: 10.1016/s1359-6349(10)71787-0.
  • 393 Phase I pharmacokinetics and pharmacodynamics of GDC-0152, a novel IAP protein antagonist, administered to patients with locally advanced or metastatic malignanciesFairbrother W, LoRusso P, Wagner A, Budha N, Darbonne W, Shin Y, Wong H, Chan I, Ware J, Eckhardt S. 393 Phase I pharmacokinetics and pharmacodynamics of GDC-0152, a novel IAP protein antagonist, administered to patients with locally advanced or metastatic malignancies European Journal Of Cancer Supplements 2010, 8: 125. DOI: 10.1016/s1359-6349(10)72100-5.
  • 388 Imetelstat sodium (GRN163L), a telomerase inhibitor: tolerability, pharmacokinetics and pharmacodynamic activity using an intermittent once every four weeks dosing schedule in patients with advanced solid tumorsRatain M, Kelsey S, Janisch L, Smith J, Go N, Lin T, Maitland M, Kindler H, LoRusso P. 388 Imetelstat sodium (GRN163L), a telomerase inhibitor: tolerability, pharmacokinetics and pharmacodynamic activity using an intermittent once every four weeks dosing schedule in patients with advanced solid tumors European Journal Of Cancer Supplements 2010, 8: 123. DOI: 10.1016/s1359-6349(10)72095-4.
  • 3LB MEDI-573, a dual IGF-1/-2 neutralizing antibody, blocks IGF-1R and IR-A signaling and maintains glucose homeostasis in a Phase 1 study for advanced solid tumorsMenefee M, LoRusso P, Vin J, McDevitt J, Huang W, Lam B, Jin F, Chang Y, Haluska P. 3LB MEDI-573, a dual IGF-1/-2 neutralizing antibody, blocks IGF-1R and IR-A signaling and maintains glucose homeostasis in a Phase 1 study for advanced solid tumors European Journal Of Cancer Supplements 2010, 8: 3-4. DOI: 10.1016/s1359-6349(10)71700-6.
  • 381 Preliminary results of a dose escalation study of the Fibroblast Growth Factor (FGF) “trap” FP-1039 (FGFR1:Fc) in patients with advanced malignanciesTolcher A, Papadopolous K, Patniak A, Heath E, Weise A, Prokop T, Morrone S, Zanghi J, Keer H, LoRusso P. 381 Preliminary results of a dose escalation study of the Fibroblast Growth Factor (FGF) “trap” FP-1039 (FGFR1:Fc) in patients with advanced malignancies European Journal Of Cancer Supplements 2010, 8: 121. DOI: 10.1016/s1359-6349(10)72088-7.
  • 383 First-in-human study of PF-04691502, a small molecule oral dual inhibitor of PI3K and mTOR in patients with advanced cancer: Preliminary report on safety and pharmacokineticsBritten C, Adjei A, Millham R, Houk B, Wainberg Z, Guthrie T, Dy G, LoRusso P. 383 First-in-human study of PF-04691502, a small molecule oral dual inhibitor of PI3K and mTOR in patients with advanced cancer: Preliminary report on safety and pharmacokinetics European Journal Of Cancer Supplements 2010, 8: 121-122. DOI: 10.1016/s1359-6349(10)72090-5.
  • 189 Preclinical activity of the poly (ADP-ribose) polymerase (PARP) inhibitor ABT-888 in combination with irinotecan in ovarian and triple negative breast cancersNechiporchik N, Lieb K, Marquette L, Polin L, Peters G, Chen A, Ethier S, LoRusso P, Burger A. 189 Preclinical activity of the poly (ADP-ribose) polymerase (PARP) inhibitor ABT-888 in combination with irinotecan in ovarian and triple negative breast cancers European Journal Of Cancer Supplements 2010, 8: 64. DOI: 10.1016/s1359-6349(10)71894-2.
  • Quantitative assessment of diagnostic markers and correlations with efficacy in two phase II studies of trastuzumab-DM1 (T-DM1) for patients (pts) with metastatic breast cancer (MBC) who had progressed on prior HER2-directed therapy.LoRusso P, Krop I, Burris H, Vukelja S, Miller K, Zheng M, Chu Y, Lu M, Amler L, Rugo H. Quantitative assessment of diagnostic markers and correlations with efficacy in two phase II studies of trastuzumab-DM1 (T-DM1) for patients (pts) with metastatic breast cancer (MBC) who had progressed on prior HER2-directed therapy. Journal Of Clinical Oncology 2010, 28: 1016-1016. DOI: 10.1200/jco.2010.28.15_suppl.1016.
  • An international pooled analysis identifying predictive factors associated with toxicities in phase I trials (Delphi).Gomez-Roca C, Baey C, Olmos D, Berens A, Bigger E, LoRusso P, Rothenberg M, Kaye S, Pignon J, Soria J. An international pooled analysis identifying predictive factors associated with toxicities in phase I trials (Delphi). Journal Of Clinical Oncology 2010, 28: 2517-2517. DOI: 10.1200/jco.2010.28.15_suppl.2517.
  • A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors.Von Hoff D, LoRusso P, Tibes R, Shapiro G, Weiss G, Ware J, Fredrickson J, Mazina K, Levy G, Wagner A. A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: 2541-2541. DOI: 10.1200/jco.2010.28.15_suppl.2541.
  • Phase I study of vorinostat for patients with advanced solid tumors and hepatic dysfunction: An NCI Organ Dysfunction Working Group (ODWG) study (NCI #8057).Egorin M, Kummar S, Sarantopoulos J, Shibata S, LoRusso P, Yerk M, Lin Y, Ivy S, Belani C, Ramalingam S. Phase I study of vorinostat for patients with advanced solid tumors and hepatic dysfunction: An NCI Organ Dysfunction Working Group (ODWG) study (NCI #8057). Journal Of Clinical Oncology 2010, 28: 2545-2545. DOI: 10.1200/jco.2010.28.15_suppl.2545.
  • Hyperglycemia, hypertriglyceridemia, and hypercholesterolemia in a phase I trial of the combination of an mTOR inhibitor and IGF-1 receptor inhibitor.Busaidy N, Kurzrock R, LoRusso P, Owens A, Chen H, Doyle L, Zhang J, Lawhorn K, Chandhasin C, Naing A. Hyperglycemia, hypertriglyceridemia, and hypercholesterolemia in a phase I trial of the combination of an mTOR inhibitor and IGF-1 receptor inhibitor. Journal Of Clinical Oncology 2010, 28: 2597-2597. DOI: 10.1200/jco.2010.28.15_suppl.2597.
  • Dual inhibition of IGFR and mTOR pathways.Naing A, LoRusso P, Gupta S, Benjamin R, Rohren E, Chen H, Doyle L, Berry D, Amin H, Kurzrock R. Dual inhibition of IGFR and mTOR pathways. Journal Of Clinical Oncology 2010, 28: 3007-3007. DOI: 10.1200/jco.2010.28.15_suppl.3007.
  • A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765 (SAR245409), a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced malignancies.Brana I, LoRusso P, Baselga J, Heath E, Patnaik A, Gendreau S, Laird A, Papadopoulos K. A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765 (SAR245409), a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced malignancies. Journal Of Clinical Oncology 2010, 28: 3030-3030. DOI: 10.1200/jco.2010.28.15_suppl.3030.
  • Pharmacodynamically guided dose selection of PF-00337210, a VEGFR2 tyrosine kinase (TK) inhibitor, in a phase I study.Liu G, LoRusso P, Heath E, Bruce J, Traynor A, Pilat M, Breazna A, Tortorici M, Shalinsky D, Ricart A. Pharmacodynamically guided dose selection of PF-00337210, a VEGFR2 tyrosine kinase (TK) inhibitor, in a phase I study. Journal Of Clinical Oncology 2010, 28: 3033-3033. DOI: 10.1200/jco.2010.28.15_suppl.3033.
  • Interim safety and pharmacodynamic results for ALN-VSP02, a novel RNAi therapeutic for solid tumors with liver involvement.Gollob J, Infante J, Shapiro G, LoRusso P, Dezube B, Heymach J, Cehelsky J, Falzone R, Vaishnaw A, Burris H. Interim safety and pharmacodynamic results for ALN-VSP02, a novel RNAi therapeutic for solid tumors with liver involvement. Journal Of Clinical Oncology 2010, 28: 3042-3042. DOI: 10.1200/jco.2010.28.15_suppl.3042.
  • A phase I safety and pharmacokinetic (PK) study of the PI3K inhibitor XL147 (SAR245408) in combination with erlotinib in patients (pts) with advanced solid tumors.Moldovan C, Soria J, LoRusso P, Guthrie T, Song C, Nguyen L, Martini J, Infante J, Burris H. A phase I safety and pharmacokinetic (PK) study of the PI3K inhibitor XL147 (SAR245408) in combination with erlotinib in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: 3070-3070. DOI: 10.1200/jco.2010.28.15_suppl.3070.
  • A phase I study of EC0225 administered weeks 1 and 2 of a 4-week cycle.Sharma S, Sausville E, LoRusso P, Vogelzang N, Samlowski W, Carter J, Forman K, Bever S, Messmann R. A phase I study of EC0225 administered weeks 1 and 2 of a 4-week cycle. Journal Of Clinical Oncology 2010, 28: 3082-3082. DOI: 10.1200/jco.2010.28.15_suppl.3082.
  • A phase I dose-escalation study of the Hsp90 inhibitor STA-9090 administered twice weekly in patients with solid tumors.Cleary J, Heath E, Kwak E, Dezube B, Gandhi L, Zack C, Bradley R, Vukovic V, Shapiro G, LoRusso P. A phase I dose-escalation study of the Hsp90 inhibitor STA-9090 administered twice weekly in patients with solid tumors. Journal Of Clinical Oncology 2010, 28: 3083-3083. DOI: 10.1200/jco.2010.28.15_suppl.3083.
  • A phase I study of the folate-targeted conjugate EC0489 in patients with refractory or advanced metastatic cancer.Harb W, Conley B, LoRusso P, Sausville E, Heath E, Chandana S, Hamm M, Carter J, Perez W, Messmann R. A phase I study of the folate-targeted conjugate EC0489 in patients with refractory or advanced metastatic cancer. Journal Of Clinical Oncology 2010, 28: 3088-3088. DOI: 10.1200/jco.2010.28.15_suppl.3088.
  • Phase I evaluation of the safety of conatumumab (AMG 655) in combination with AMG 479 in patients (pts) with advanced, refractory solid tumors.Chawla S, Tabernero J, Kindler H, Chiorean E, LoRusso P, Hsu M, Haddad V, Bach B, Baselga J. Phase I evaluation of the safety of conatumumab (AMG 655) in combination with AMG 479 in patients (pts) with advanced, refractory solid tumors. Journal Of Clinical Oncology 2010, 28: 3102-3102. DOI: 10.1200/jco.2010.28.15_suppl.3102.
  • A phase I study of oral administration of MGCD265 in patients with advanced malignancies (study 265-102).Heath E, LoRusso P, Kurzrock R, Falchook G, Maroun C, Drouin M, Juretic M, Martell R, Besterman J, Wheler J. A phase I study of oral administration of MGCD265 in patients with advanced malignancies (study 265-102). Journal Of Clinical Oncology 2010, 28: 3108-3108. DOI: 10.1200/jco.2010.28.15_suppl.3108.
  • A phase Ib study to evaluate the fully human monoclonal antibody MNRP1685A (anti-NRP1) administered intravenously in combination with bevacizumab with or without weekly paclitaxel in patients with advanced solid tumors.Patnaik A, Weekes C, Hegde P, Xin Y, Yu R, Xiang H, Brachmann R, LoRusso P. A phase Ib study to evaluate the fully human monoclonal antibody MNRP1685A (anti-NRP1) administered intravenously in combination with bevacizumab with or without weekly paclitaxel in patients with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: tps180-tps180. DOI: 10.1200/jco.2010.28.15_suppl.tps180.
  • Abstract 2765: Cytoplasmic expression of the aryl hydrocarbon receptor elicits sensitivity and nuclear expression resistance to aminoflavone prodrugStark K, Nguyen B, Shelton P, Polin L, LoRusso P, Burger A. Abstract 2765: Cytoplasmic expression of the aryl hydrocarbon receptor elicits sensitivity and nuclear expression resistance to aminoflavone prodrug Cancer Research 2010, 70: 2765-2765. DOI: 10.1158/1538-7445.am10-2765.
  • Abstract LB-171: A phase 1 dose escalation study of BBI608, a first-in-class cancer stem cell pathway inhibitor in patients with advanced malignanciesLangleben A, Supko J, Hotte S, Lorusso P, Miller W, Hurtubise A, Leggett D, Li W, Borodyanski L, Li C. Abstract LB-171: A phase 1 dose escalation study of BBI608, a first-in-class cancer stem cell pathway inhibitor in patients with advanced malignancies Cancer Research 2010, 70: lb-171-lb-171. DOI: 10.1158/1538-7445.am10-lb-171.
  • A Phase II Study of Trastuzumab-DM1 (T-DM1), a Novel HER2 Antibody–Drug Conjugate, in HER2+ Metastatic Breast Cancer (MBC) Patients Previously Treated with Conventional Chemotherapy, Lapatinib and Trastuzumab.Krop I, LoRusso P, Miller K, Modi S, Yardley D, Rodriguez G, Agresta S, Zheng M, Amler L, Rugo H. A Phase II Study of Trastuzumab-DM1 (T-DM1), a Novel HER2 Antibody–Drug Conjugate, in HER2+ Metastatic Breast Cancer (MBC) Patients Previously Treated with Conventional Chemotherapy, Lapatinib and Trastuzumab. Cancer Research 2009, 69: 5090-5090. DOI: 10.1158/0008-5472.sabcs-09-5090.
  • Abstract A44: Predictive biomarkers of efficacy to the hedgehog pathway inhibitor, GDC-0449, in advanced basal cell carcinoma and medulloblastoma in phase I studiesYauch R, Januario T, Fu L, Holcomb T, Stinson J, Pujara K, Callahan C, Koeppen H, Reddy J, Von Hoff D, LoRusso P, Rudin C, de Sauvage F, Low J. Abstract A44: Predictive biomarkers of efficacy to the hedgehog pathway inhibitor, GDC-0449, in advanced basal cell carcinoma and medulloblastoma in phase I studies Molecular Cancer Therapeutics 2009, 8: a44-a44. DOI: 10.1158/1535-7163.targ-09-a44.
  • Abstract A8: Final results of a phase I dose escalation study of the safety and pharmacokinetics of foretinib administered orally daily to patients with solid tumorsLoRusso P, Eder J, Sherman L, McCallum S, Liu Y, Bottaro D, Cecchi F, Rabe D, Miles D, Shapiro G. Abstract A8: Final results of a phase I dose escalation study of the safety and pharmacokinetics of foretinib administered orally daily to patients with solid tumors Molecular Cancer Therapeutics 2009, 8: a8-a8. DOI: 10.1158/1535-7163.targ-09-a8.
  • Abstract B51: A phase I dose-escalation study of MGCD265 in patients with advanced malignancies (study 265-102)LoRusso P, Kurzrock R, Weise A, Heath E, Drouin M, Juretic M, Maroun C, Karam A, Mehran M, Besterman J, Martell R, Wheler J. Abstract B51: A phase I dose-escalation study of MGCD265 in patients with advanced malignancies (study 265-102) Molecular Cancer Therapeutics 2009, 8: b51-b51. DOI: 10.1158/1535-7163.targ-09-b51.
  • Abstract B61: Multicenter phase I clinical trial of an insulin like growth factor (IGF-R) inhibitor (IMC-A12) in combination with a mammalian target of rapamycin (mTOR) inhibitor (CCI-779) to overcome resistance to mTOR inhibitionNaing A, Kurzrock R, Chen H, Hong D, Falchook G, Doyle L, Iawhorn K, Burger A, Ng C, Amin H, LoRusso P. Abstract B61: Multicenter phase I clinical trial of an insulin like growth factor (IGF-R) inhibitor (IMC-A12) in combination with a mammalian target of rapamycin (mTOR) inhibitor (CCI-779) to overcome resistance to mTOR inhibition Molecular Cancer Therapeutics 2009, 8: b61-b61. DOI: 10.1158/1535-7163.targ-09-b61.
  • Abstract C197: A phase 1 safety and pharmacokinetic (PK) study of the PI3K inhibitor XL147 (SAR245408) in combination with erlotinib in patients with advanced solid tumorsFaulkner N, LoRusso P, Guthrie T, Soria J, Bahleda R, Bendell J, Infante J, Massard C, Van Leeuwen B, Martini J, Scheffold C, Burris H. Abstract C197: A phase 1 safety and pharmacokinetic (PK) study of the PI3K inhibitor XL147 (SAR245408) in combination with erlotinib in patients with advanced solid tumors Molecular Cancer Therapeutics 2009, 8: c197-c197. DOI: 10.1158/1535-7163.targ-09-c197.
  • 1205 A first-in-human Phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumoursVon Hoff D, Wagner A, LoRusso P, Tibes R, Jin J, Ware J, Yan Y, Derynck M, Dolezal M, Demetri G. 1205 A first-in-human Phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumours European Journal Of Cancer Supplements 2009, 7: 122. DOI: 10.1016/s1359-6349(09)70417-3.
  • Tremelimumab in combination with exemestane as novel immunotherapy for patients with advanced breast cancerVonderheide R, LoRusso P, Khalil M, Heath E, Khaira D, Soulieres D, Dorazio P, Mariani G, Usari T, Domchek S. Tremelimumab in combination with exemestane as novel immunotherapy for patients with advanced breast cancer Journal Of Clinical Oncology 2009, 27: 3034-3034. DOI: 10.1200/jco.2009.27.15_suppl.3034.
  • A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumorsWagner A, Von Hoff D, LoRusso P, Tibes R, Mazina K, Ware J, Yan Y, Derynck M, Demetri G. A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors Journal Of Clinical Oncology 2009, 27: 3501-3501. DOI: 10.1200/jco.2009.27.15_suppl.3501.
  • A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced solid tumorsLoRusso P, Markman B, Tabernero J, Shazer R, Nguyen L, Heath E, Patnaik A, Papadopoulos K. A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced solid tumors Journal Of Clinical Oncology 2009, 27: 3502-3502. DOI: 10.1200/jco.2009.27.15_suppl.3502.
  • Phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of PF-00337210, a highly selective VEGFR inhibitorLiu G, LoRusso P, Goncalves P, Holen K, Traynor A, Zhang J, Hee B, Tortorici M, Shalinsky D, Ricart A. Phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of PF-00337210, a highly selective VEGFR inhibitor Journal Of Clinical Oncology 2009, 27: 3519-3519. DOI: 10.1200/jco.2009.27.15_suppl.3519.
  • Phase I evaluation of lapatinib and everolimus in patients with advanced malignancies: Southwest Oncology Group trial S0528Hoban C, Hoering A, Synold T, Chung V, Gandara D, Schott A, Kingsbury L, Lew D, LoRusso P, Gadgeel S. Phase I evaluation of lapatinib and everolimus in patients with advanced malignancies: Southwest Oncology Group trial S0528 Journal Of Clinical Oncology 2009, 27: 3553-3553. DOI: 10.1200/jco.2009.27.15_suppl.3553.
  • Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: Updated phase I study resultsHeath E, Blumenschein G, Cohen R, LoRusso P, LoConte N, Kim S, Chao R, Wilding G. Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: Updated phase I study results Journal Of Clinical Oncology 2009, 27: e14509-e14509. DOI: 10.1200/jco.2009.27.15_suppl.e14509.
  • Phase I study of MGCD265 administered intermittently to patients with advanced malignancies (Study 265–102)Hong D, LoRusso P, Kurzrock R, Maroun C, Mehran M, Drouin M, Martell R, Wheler J. Phase I study of MGCD265 administered intermittently to patients with advanced malignancies (Study 265–102) Journal Of Clinical Oncology 2009, 27: e14516-e14516. DOI: 10.1200/jco.2009.27.15_suppl.e14516.
  • Phase I study combining an IGFR inhibitor (IMC-A12) and an mTOR inhibitor (temsirolimus) in patients with solid tumors or lymphomaNaing A, LoRusso P, Mills G, Berry D, Doyle L, Rohren E, Burger A, Chen H, Busaidy N, Kurzrock R. Phase I study combining an IGFR inhibitor (IMC-A12) and an mTOR inhibitor (temsirolimus) in patients with solid tumors or lymphoma Journal Of Clinical Oncology 2009, 27: e14535-e14535. DOI: 10.1200/jco.2009.27.15_suppl.e14535.
  • Pharmacogenetics of a PARP inhibitor ABT-888 metabolic pathwayLi J, Sha X, LoRusso P. Pharmacogenetics of a PARP inhibitor ABT-888 metabolic pathway Journal Of Clinical Oncology 2009, 27: e14556-e14556. DOI: 10.1200/jco.2009.27.15_suppl.e14556.
  • Cediranib, a VEGF receptor 1, 2, and 3 inhibitor, and pemetrexed in patients (pts) with recurrent non-small cell lung cancer (NSCLC)Gadgeel S, Wozniak A, Edelman M, Valdivieso M, Heilbrun L, Venkatramanamoorthy R, Shields A, LoRusso P, Hackstock D, Ruckdeschel J. Cediranib, a VEGF receptor 1, 2, and 3 inhibitor, and pemetrexed in patients (pts) with recurrent non-small cell lung cancer (NSCLC) Journal Of Clinical Oncology 2009, 27: e19007-e19007. DOI: 10.1200/jco.2009.27.15_suppl.e19007.
  • Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, MichiganVishnu P, Jasti P, Ding L, Heilbrun L, Venkatramanamoorthy R, LoRusso P, Heath E. Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan Journal Of Clinical Oncology 2009, 27: e20626-e20626. DOI: 10.1200/jco.2009.27.15_suppl.e20626.
  • In ReplyLoRusso P, Burris H, Jones S, Fleming R, Koch K. In Reply Journal Of Clinical Oncology 2009, 27: 316-317. DOI: 10.1200/jco.2008.20.0758.
  • 223 POSTER Pharmacokinetics and pharmacodynamic biomarkers for the pan-PI3K inhibitor GDC-0941: Initial Phase I evaluationLoRusso P, Sarker D, Von Hoff D, Tibes R, Derynck M, Ware J, Yan Y, Demetri G, de Bono J, Wagner A. 223 POSTER Pharmacokinetics and pharmacodynamic biomarkers for the pan-PI3K inhibitor GDC-0941: Initial Phase I evaluation European Journal Of Cancer Supplements 2008, 6: 70-71. DOI: 10.1016/s1359-6349(08)72155-4.
  • 406 POSTER IMC-18F1, a recombinant human monoclonal antibody (MAb) against the vascular endothelial growth factor receptor-1 (VEGFR-1), in the treatment of patients (pts) with advanced solid malignancies: A Phase 1 studyKrishnamurthi S, Goncalves P, Fox F, Hall N, Rowinsky E, Schwartz J, Youssoufian H, LoRusso P. 406 POSTER IMC-18F1, a recombinant human monoclonal antibody (MAb) against the vascular endothelial growth factor receptor-1 (VEGFR-1), in the treatment of patients (pts) with advanced solid malignancies: A Phase 1 study European Journal Of Cancer Supplements 2008, 6: 127-128. DOI: 10.1016/s1359-6349(08)72340-1.
  • 355 POSTER Updated safety and efficacy data from a first-in-human, first-in-class, phase I study of Hedgehog pathway antagonist, GDC-0449Rudin C, Von Hoff D, LoRusso P, Vernillet L, Yauch R, Darbonne W, Mackey H, de Sauvage F, Low J, Reddy J. 355 POSTER Updated safety and efficacy data from a first-in-human, first-in-class, phase I study of Hedgehog pathway antagonist, GDC-0449 European Journal Of Cancer Supplements 2008, 6: 112-113. DOI: 10.1016/s1359-6349(08)72289-4.
  • 554 POSTER Pharmacokinetic (PK) and pharmacodynamic (PD) results of Phase I studies of IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid malignanciesRothenberg M, Poplin E, LoRusso P, Yu E, Schwartz J, Fox F, Mehnert J, Sandler A, Rowinsky E, Higano C. 554 POSTER Pharmacokinetic (PK) and pharmacodynamic (PD) results of Phase I studies of IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid malignancies European Journal Of Cancer Supplements 2008, 6: 174-175. DOI: 10.1016/s1359-6349(08)72488-1.
  • 216 POSTER A phase I dose-escalation study of the safety, pharmacokinetics and pharmacodynamics of XL765, a novel inhibitor of PI3K and mTOR, administered orally to patients with solid tumorsMarkman B, LoRusso P, Patnaik A, Heath E, Laird A, van Leeuwen B, Papadopoulos K, Baselga J. 216 POSTER A phase I dose-escalation study of the safety, pharmacokinetics and pharmacodynamics of XL765, a novel inhibitor of PI3K and mTOR, administered orally to patients with solid tumors European Journal Of Cancer Supplements 2008, 6: 68-69. DOI: 10.1016/s1359-6349(08)72148-7.
  • 429 POSTER Phase 1 study of food effects on pharmacokinetics of brivanib alaninate in patients with advanced or metastatic solid tumorsHurwitz H, LoRusso P, Shapiro G, Wolanksi A, Chemidlin J, Masson E, Syed S, Kollia G, Conlon K. 429 POSTER Phase 1 study of food effects on pharmacokinetics of brivanib alaninate in patients with advanced or metastatic solid tumors European Journal Of Cancer Supplements 2008, 6: 135. DOI: 10.1016/s1359-6349(08)72363-2.
  • 42 POSTER NPI-2358 (a novel vascular disrupting agent) Phase 1 dose escalation trial with an RP2D cohortMita M, Spear M, Yee L, Papadopoulos K, Heath E, Pilat M, Romero O, Lloyd G, Mita A, LoRusso P. 42 POSTER NPI-2358 (a novel vascular disrupting agent) Phase 1 dose escalation trial with an RP2D cohort European Journal Of Cancer Supplements 2008, 6: 17. DOI: 10.1016/s1359-6349(08)71974-8.
  • Patupilone combined with carboplatin in patients (pts) with advanced solid tumors: preliminary safety and activity resultsFracasso P, Ravaud A, Baggstrom M, LoRusso P, Jones D, Sguotti C, Urban P, Gao B, Medioni J. Patupilone combined with carboplatin in patients (pts) with advanced solid tumors: preliminary safety and activity results Journal Of Clinical Oncology 2008, 26: 13544-13544. DOI: 10.1200/jco.2008.26.15_suppl.13544.
  • Objective versus subjective predictors of patient clinical benefit from phase I treatmentHarper F, Heath E, Gleason M, LoRusso P, Albrecht T. Objective versus subjective predictors of patient clinical benefit from phase I treatment Journal Of Clinical Oncology 2008, 26: 13526-13526. DOI: 10.1200/jco.2008.26.15_suppl.13526.
  • First in human phase I study of MK-2461, a small molecule inhibitor of c-Met, for patients with advanced solid tumorsCamacho L, Moulder S, LoRusso P, Blumenschein G, Bristow P, Kurzrock R, Fu S, Schlienger K, Bergstrom D. First in human phase I study of MK-2461, a small molecule inhibitor of c-Met, for patients with advanced solid tumors Journal Of Clinical Oncology 2008, 26: 14657-14657. DOI: 10.1200/jco.2008.26.15_suppl.14657.
  • Phase I study of sunitinib in combination with carboplatin (C) plus paclitaxel (P) in patients (pts) with advanced solid tumors (STs)Heath E, Blumenschein G, Cohen R, LoRusso P, LoConte N, Kim S, Chao R, Wilding G. Phase I study of sunitinib in combination with carboplatin (C) plus paclitaxel (P) in patients (pts) with advanced solid tumors (STs) Journal Of Clinical Oncology 2008, 26: 3565-3565. DOI: 10.1200/jco.2008.26.15_suppl.3565.
  • A phase I trial of GRN163L (GRN), a first-in-class telomerase inhibitor, in advanced solid tumorsRatain M, Benedetti F, Janisch L, Khor S, Schilsky R, Cohen E, Maitland M, Elias L, LoRusso P. A phase I trial of GRN163L (GRN), a first-in-class telomerase inhibitor, in advanced solid tumors Journal Of Clinical Oncology 2008, 26: 3581-3581. DOI: 10.1200/jco.2008.26.15_suppl.3581.
  • A phase IB study evaluating BSI-201 in combination with chemotherapy in subjects with advanced solid tumorsMahany J, Lewis N, Heath E, LoRusso P, Mita M, Rodon J, Tolcher A, Sherman B, Bradley C, Papadopoulos K. A phase IB study evaluating BSI-201 in combination with chemotherapy in subjects with advanced solid tumors Journal Of Clinical Oncology 2008, 26: 3579-3579. DOI: 10.1200/jco.2008.26.15_suppl.3579.
  • Phase I study of NPI-2358 (a novel vascular disrupting agent) in patients with solid tumors and lymphomasMita A, Yee L, Papadopoulos K, Heath E, Romero O, Lloyd G, Cropp G, Spear M, Mita M, LoRusso P. Phase I study of NPI-2358 (a novel vascular disrupting agent) in patients with solid tumors and lymphomas Journal Of Clinical Oncology 2008, 26: 3525-3525. DOI: 10.1200/jco.2008.26.15_suppl.3525.
  • A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a novel PI3K inhibitor, XL765, administered orally to patients (pts) with advanced solid tumorsPapadopoulos K, Markman B, Tabernero J, Patnaik A, Heath E, DeCillis A, Laird D, Aggarwal S, Nguyen L, LoRusso P. A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a novel PI3K inhibitor, XL765, administered orally to patients (pts) with advanced solid tumors Journal Of Clinical Oncology 2008, 26: 3510-3510. DOI: 10.1200/jco.2008.26.15_suppl.3510.
  • A first-in-human, first-in-class, phase (ph) I study of systemic Hedgehog (Hh) pathway antagonist, GDC-0449, in patients (pts) with advanced solid tumorsLoRusso P, Rudin C, Borad M, Vernillet L, Darbonne W, Mackey H, DiMartino J, de Sauvage F, Low J, Von Hoff D. A first-in-human, first-in-class, phase (ph) I study of systemic Hedgehog (Hh) pathway antagonist, GDC-0449, in patients (pts) with advanced solid tumors Journal Of Clinical Oncology 2008, 26: 3516-3516. DOI: 10.1200/jco.2008.26.15_suppl.3516.
  • Phase 1 study of weekly anti-vascular endothelial growth factor receptor-1 (VEGFR-1) monoclonal antibody IMC-18F1 in patients with advanced solid malignanciesKrishnamurthi S, LoRusso P, Goncalves P, Fox F, Rowinsky E, Schwartz J, Youssoufian H. Phase 1 study of weekly anti-vascular endothelial growth factor receptor-1 (VEGFR-1) monoclonal antibody IMC-18F1 in patients with advanced solid malignancies Journal Of Clinical Oncology 2008, 26: 14630-14630. DOI: 10.1200/jco.2008.26.15_suppl.14630.
  • Abstract LB-138: Efficacy data of GDC-0449, a systemic Hedgehog pathway antagonist, in a first-in-human, first-in-class Phase I study with locally advanced, multifocal or metastatic basal cell carcinoma patientsVon Hoff D, Rudin C, LoRusso P, Borad M, Korn R, Heath E, Yauch R, Darbonne W, Kadel E, Zerivitz K, Nelson L, Mackey H, Marsters J, de Sauvage F, Low J. Abstract LB-138: Efficacy data of GDC-0449, a systemic Hedgehog pathway antagonist, in a first-in-human, first-in-class Phase I study with locally advanced, multifocal or metastatic basal cell carcinoma patients Cancer Research 2008, 68: lb-138-lb-138. DOI: 10.1158/1538-7445.am2008-lb-138.
  • Abstract LB-202: Phase 1 dose escalation trial of the novel vascular disrupting agent NPI-2358Mita M, Spear M, Yee L, Papadopoulos K, Heath E, Romero O, Lloyd G, Cropp G, Mita A, LoRusso P. Abstract LB-202: Phase 1 dose escalation trial of the novel vascular disrupting agent NPI-2358 Cancer Research 2008, 68: lb-202-lb-202. DOI: 10.1158/1538-7445.am2008-lb-202.
  • Tolerability of lapatinib in combination with taxanes (T) in 507 patients with breast cancer (BC)Crown J, Burris H, Di Leo A, Jagiello-Gruszfeld A, Jones S, LoRusso P, Oliva C, Parikh R, Stein S, Koehler M. Tolerability of lapatinib in combination with taxanes (T) in 507 patients with breast cancer (BC) European Journal Of Cancer Supplements 2008, 6: 200. DOI: 10.1016/s1359-6349(08)70818-8.
  • Chapter 47 Phase 1 Trials TodayLoRusso P, Bekele B, Boerner S, Davis D, Evelhoch J, Herbst R. Chapter 47 Phase 1 Trials Today 2008, 553-570. DOI: 10.1016/b978-141603703-3.10047-0.
  • List of Contributing AuthorsAaronson S, Abbruzzese J, Abel E, Anderson K, Arrick B, Bafico A, Barbash O, Bast R, Baylin S, Bekele B, Bertino J, Boerner S, Bommer G, Borden E, Buchstaller J, Buetow K, Burman K, Calin G, Campisi J, Caprioli R, Carroll P, Chaurand P, Chi J, Cleveland J, Collins J, Cortes J, Costello J, Cox J, Croce C, D'Andrea A, Davis D, Deberardinis R, Demasi J, Diehl J, Digiovanni J, Dorsey F, Egeblad M, Ekmekcioglu S, Evelhoch J, Fearon E, Febbo P, Feng Z, Fletcher C, Frankel A, Friedman D, Fury M, Gambhir S, Gazdar A, Girard L, Glick A, Gonzalez-Angulo A, Gray J, Greene K, Grimm E, Grumolato L, Guertin D, Hait W, Havrda M, Hennessy B, Herbst R, Houghton A, Houghton P, Howley P, Hu W, Hwu P, Israel M, Jacks T, Jorgensen C, Kantarjian H, Keith B, Kelsen D, Korn W, Kundra P, Kurzrock R, Lee J, Levine A, Li L, Lippman S, Littlepage L, Liu Y, Look T, Lorusso P, Malkin D, Margolin J, Matrisian L, Mccormick F, Mendelsohn J, Merghoub T, Mills G, Minna J, Morrison S, Morton C, Neckers L, Nevins J, Okino S, Pardoll D, Pawson T, Payne E, Pfister D, Polsky D, Poplack D, Posada J, Powis G, Quintana E, Quintás-Cardama A, Rabin K, Reimann J, Rubin E, Sabatini D, Sato M, Sausville E, Sen G, Shah M, Shames D, Shoemaker R, Sikic B, Silverman R, Simon M, Spellman P, Steeves M, Thompson C, Tonon G, Weinberg R, Welch D, Werb Z, Winslow M, Woodward W, Xiong H, Yaghoubi S, Yuspa S. List of Contributing Authors 2008, vii-xiii. DOI: 10.1016/b978-141603703-3.10061-5.
  • 708 POSTER AMG 386, a first-in-class, selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumorsMita A, Wang D, Takimoto C, Martin D, Nguyen L, Rasmussen E, Storgard C, LoRusso P. 708 POSTER AMG 386, a first-in-class, selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors European Journal Of Cancer Supplements 2007, 5: 109-110. DOI: 10.1016/s1359-6349(07)70507-4.
  • First-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumorsLoRusso P, Hong D, Heath E, Kurzrock R, Wang D, Hsu M, Goyal L, Wiezorek J, Storgard C, Herbst R. First-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumors Journal Of Clinical Oncology 2007, 25: 3534-3534. DOI: 10.1200/jco.2007.25.18_suppl.3534.
  • A phase I study of BMS-582664 (brivanib alaninate), an oral dual inhibitor of VEGFR and FGFR tyrosine kinases, in combination with full-dose cetuximab in patients (pts) with advanced gastrointestinal malignancies (AGM) who failed prior therapyGarrett C, Siu L, Giaccone G, El-Khoueiry A, Marshall J, LoRusso P, Velasquez L, Kollia G, He P, Feltquate D. A phase I study of BMS-582664 (brivanib alaninate), an oral dual inhibitor of VEGFR and FGFR tyrosine kinases, in combination with full-dose cetuximab in patients (pts) with advanced gastrointestinal malignancies (AGM) who failed prior therapy Journal Of Clinical Oncology 2007, 25: 14018-14018. DOI: 10.1200/jco.2007.25.18_suppl.14018.
  • AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumorsMita A, Wang D, Takimoto C, Malseed E, Nguyen L, Rasmussen E, Storgard C, LoRusso P. AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors Journal Of Clinical Oncology 2007, 25: 14033-14033. DOI: 10.1200/jco.2007.25.18_suppl.14033.
  • A phase 1 dynamic accelerated titration dose escalation study of the vascular disrupting agent NPI-2358Spear M, LoRusso P, Tolcher A, Lin C, Wang D, Heath E, Lloyd G, Cropp G, Papadopoulos K. A phase 1 dynamic accelerated titration dose escalation study of the vascular disrupting agent NPI-2358 Journal Of Clinical Oncology 2007, 25: 14097-14097. DOI: 10.1200/jco.2007.25.18_suppl.14097.
  • Development of a functional assessment of side-effects to therapy (FAST) questionnaire to assess dermatology-related quality of life in patients treated with EGFR inhibitors (EGFRI): The FAST-EGFRIWagner L, Lai S, Aneja M, Lorusso P, Perez-Soler R, O’Brien B, Patel J, Lacouture M. Development of a functional assessment of side-effects to therapy (FAST) questionnaire to assess dermatology-related quality of life in patients treated with EGFR inhibitors (EGFRI): The FAST-EGFRI Journal Of Clinical Oncology 2007, 25: 19532-19532. DOI: 10.1200/jco.2007.25.18_suppl.19532.
  • Phase I study of LY573636-sodium, an acylsulfonamide anti-cancer compound with a novel mechanism of action, administered as 24-hour continuous infusion in patients with advanced solid tumorsSlapak C, LoRusso P, Mendelson D, Sykes A, De Alwis D, Wagner M, Ilaria R, Gordon M. Phase I study of LY573636-sodium, an acylsulfonamide anti-cancer compound with a novel mechanism of action, administered as 24-hour continuous infusion in patients with advanced solid tumors Journal Of Clinical Oncology 2007, 25: 2542-2542. DOI: 10.1200/jco.2007.25.18_suppl.2542.
  • A phase I study of EC145 administered weeks 1 and 3 of a 4-week cycle in patients with refractory solid tumorsSausville E, LoRusso P, Quinn M, Forman K, Leamon C, Morganstern D, Bever S, Messmann R. A phase I study of EC145 administered weeks 1 and 3 of a 4-week cycle in patients with refractory solid tumors Journal Of Clinical Oncology 2007, 25: 2577-2577. DOI: 10.1200/jco.2007.25.18_suppl.2577.
  • A phase I, first in man study of weekly IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid tumorsHigano C, Yu E, Whiting S, Gordon M, LoRusso P, Fox F, Katz T, Roecker J, Schwartz J. A phase I, first in man study of weekly IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid tumors Journal Of Clinical Oncology 2007, 25: 3505-3505. DOI: 10.1200/jco.2007.25.18_suppl.3505.
  • Phase I experience with c-MET inhibitor XL880 administered orally to patients (pts) with solid tumorsEder J, Heath E, Appleman L, Shapiro G, Wang D, Malburg L, Zhu A, Leader T, Wolanski A, LoRusso P. Phase I experience with c-MET inhibitor XL880 administered orally to patients (pts) with solid tumors Journal Of Clinical Oncology 2007, 25: 3526-3526. DOI: 10.1200/jco.2007.25.18_suppl.3526.
  • Phase I trial of intravenous 17-allylaminogeldanamycin (A) and oral sorafenib (B) in pretreated advanced malignancy: Plasma Hsp90α induction correlates with clinical benefitVaishampayan U, Sausville E, Horiba M, Quinn M, Heilbrun L, Burger A, Ivy P, Li J, Lorusso P. Phase I trial of intravenous 17-allylaminogeldanamycin (A) and oral sorafenib (B) in pretreated advanced malignancy: Plasma Hsp90α induction correlates with clinical benefit Journal Of Clinical Oncology 2007, 25: 3531-3531. DOI: 10.1200/jco.2007.25.18_suppl.3531.
  • AZD2171 in combination with various anticancer regimens: Follow-up results of a phase I multi-cohort studyShields A, Heath E, DeLuca P, Pilat M, Wozniak A, Gadgeel S, Puchalski T, Xu J, Liu Q, LoRusso P. AZD2171 in combination with various anticancer regimens: Follow-up results of a phase I multi-cohort study Journal Of Clinical Oncology 2007, 25: 3544-3544. DOI: 10.1200/jco.2007.25.18_suppl.3544.
  • A phase I dose escalation trial of a daily oral CDK 4/6 inhibitor PD-0332991O’Dwyer P, LoRusso P, DeMichele A, Gupta V, Barbi A, Dials H, Chen I, Courtney R, Wilner K, Schwartz G. A phase I dose escalation trial of a daily oral CDK 4/6 inhibitor PD-0332991 Journal Of Clinical Oncology 2007, 25: 3550-3550. DOI: 10.1200/jco.2007.25.18_suppl.3550.
  • Barriers to phase I clinical trial protocol IRB approval at KCIWang D, Heath E, Powell A, Chaperon T, LaGrone F, LoRusso P. Barriers to phase I clinical trial protocol IRB approval at KCI Journal Of Clinical Oncology 2007, 25: 9080-9080. DOI: 10.1200/jco.2007.25.18_suppl.9080.
  • 648 POSTER A phase I dose-escalation study of weekly IMC-A12, a fully human insulin like growth factor-I receptor (IGF-IR) IgG1 monoclonal antibody (Mab), in patients (pts) with advanced cancerHigano C, Gordon M, LoRusso P, Fox F, Katz T, Roecker J, Rowinsky E, Youssoufian H. 648 POSTER A phase I dose-escalation study of weekly IMC-A12, a fully human insulin like growth factor-I receptor (IGF-IR) IgG1 monoclonal antibody (Mab), in patients (pts) with advanced cancer European Journal Of Cancer Supplements 2006, 4: 195. DOI: 10.1016/s1359-6349(06)70653-x.
  • 644 POSTER The novel oral taxane BMS275183 has a favorable activity and toxicity profile in a twice weekly schedule; Preliminary findings from an extended phase I trialBröker L, Veltkamp S, Heath E, Gall H, Kuenen B, Voi M, Kayitalire L, Lorusso P, Schellens J, Giaccone G. 644 POSTER The novel oral taxane BMS275183 has a favorable activity and toxicity profile in a twice weekly schedule; Preliminary findings from an extended phase I trial European Journal Of Cancer Supplements 2006, 4: 194. DOI: 10.1016/s1359-6349(06)70649-8.
  • 383 POSTER A Phase I Study of dasatinib, a Src and multi-kinase inhibitor, in patients (pts) with GIST and other solid tumorsMorgan J, Demetri G, Wang D, MacPherson I, LoRusso P, van den Abbeele A, Brunton V, Luo R, Voi M, Evans T. 383 POSTER A Phase I Study of dasatinib, a Src and multi-kinase inhibitor, in patients (pts) with GIST and other solid tumors European Journal Of Cancer Supplements 2006, 4: 118. DOI: 10.1016/s1359-6349(06)70388-3.
  • 404 POSTER Pharmacodynamics (pd) of x1880, a novel spectrum selective kinase inhibitor (SSKI), administered orally to patients (pts) with advanced solid tumors (AST)LoRusso P, Appleman L, Zhu A, Shapiro G, Fox L, Wolanski A, Hitchcock-Bryan S, Malburg L, Eder J. 404 POSTER Pharmacodynamics (pd) of x1880, a novel spectrum selective kinase inhibitor (SSKI), administered orally to patients (pts) with advanced solid tumors (AST) European Journal Of Cancer Supplements 2006, 4: 124. DOI: 10.1016/s1359-6349(06)70409-8.
  • Phase I pharmacokinetic (PK), and pharmacodynamic (PD) trial of the novel oral Notch inhibitor MK-0752 in patients (pts) with advanced breast cancer (BC) and other solid tumorsKrop I, Kosh M, Fearen I, Savoie J, Dallob A, Matthews C, Stone J, Winer E, Freedman S, Lorusso P. Phase I pharmacokinetic (PK), and pharmacodynamic (PD) trial of the novel oral Notch inhibitor MK-0752 in patients (pts) with advanced breast cancer (BC) and other solid tumors Journal Of Clinical Oncology 2006, 24: 10574-10574. DOI: 10.1200/jco.2006.24.18_suppl.10574.
  • A phase I dose escalation trial of ispinesib (SB-715992) administered days 1–3 of a 21-day cycle in patients with advanced solid tumorsHeath E, Alousi A, Eder J, Valdivieso M, Vasist L, Appleman L, Bhargava P, Colevas A, Lorusso P, Shapiro G. A phase I dose escalation trial of ispinesib (SB-715992) administered days 1–3 of a 21-day cycle in patients with advanced solid tumors Journal Of Clinical Oncology 2006, 24: 2026-2026. DOI: 10.1200/jco.2006.24.18_suppl.2026.
  • Phase I evaluation of AZD2171, a highly potent and selective inhibitor of VEGFR signaling, in combination with selected chemotherapy regimens in patients with advanced solid tumorsLorusso P, Heath E, Valdivieso M, Pilat M, Wozniak A, Gadgeel S, Shields A, Puchalski T, Ewesuedo R. Phase I evaluation of AZD2171, a highly potent and selective inhibitor of VEGFR signaling, in combination with selected chemotherapy regimens in patients with advanced solid tumors Journal Of Clinical Oncology 2006, 24: 3034-3034. DOI: 10.1200/jco.2006.24.18_suppl.3034.
  • A phase I study of a novel spectrum selective kinase inhibitor (SSKI), XL880, administered orally in patients (pts) with advanced solid tumors (STs)Eder J, Appleman L, Heath E, Malburg L, Zhu A, Pilat M, Shapiro G, Lorusso P. A phase I study of a novel spectrum selective kinase inhibitor (SSKI), XL880, administered orally in patients (pts) with advanced solid tumors (STs) Journal Of Clinical Oncology 2006, 24: 3041-3041. DOI: 10.1200/jco.2006.24.18_suppl.3041.
  • Phase-1 study of isophosphoramide mustard (IPM)-lysine in advanced cancersGale R, Van Vugt A, Rosen L, Chang L, Lorusso P, Valdivieso M, Malburg L, Struck R, Morgan L. Phase-1 study of isophosphoramide mustard (IPM)-lysine in advanced cancers Journal Of Clinical Oncology 2006, 24: 9524-9524. DOI: 10.1200/jco.2006.24.18_suppl.9524.
  • Final results of a phase I study of liposome encapsulated SN-38 (LE-SN38): Safety, pharmacogenomics, pharmacokinetics, and tumor responseKraut E, Fishman M, Lorusso P, Gordon M, Rubin E, Haas A, Fetterly G, Cullinan P, Dul J, Steinberg J. Final results of a phase I study of liposome encapsulated SN-38 (LE-SN38): Safety, pharmacogenomics, pharmacokinetics, and tumor response Journal Of Clinical Oncology 2005, 23: 2017-2017. DOI: 10.1200/jco.2005.23.16_suppl.2017.
  • Pharmacokinetics (PK) and pharmacodynamics (PD) of PD 0325901, a second generation MEK inhibitor after multiple oral doses of PD 0325901 to advanced cancer patientsMenon S, Whitfield L, Sadis S, Meyer M, Leopold J, Lorusso P, Krishnamurthi S, Rinehart J, Nabell L, Croghan G. Pharmacokinetics (PK) and pharmacodynamics (PD) of PD 0325901, a second generation MEK inhibitor after multiple oral doses of PD 0325901 to advanced cancer patients Journal Of Clinical Oncology 2005, 23: 3066-3066. DOI: 10.1200/jco.2005.23.16_suppl.3066.
  • A phase 1–2 clinical study of a second generation oral MEK inhibitor, PD 0325901 in patients with advanced cancerLorusso P, Krishnamurthi S, Rinehart J, Nabell L, Croghan G, Varterasian M, Sadis S, Menon S, Leopold J, Meyer M. A phase 1–2 clinical study of a second generation oral MEK inhibitor, PD 0325901 in patients with advanced cancer Journal Of Clinical Oncology 2005, 23: 3011-3011. DOI: 10.1200/jco.2005.23.16_suppl.3011.
  • A phase I trial of SR271425 given as a one hour infusion every 3 weeks to patients with advanced solid tumorsWadler S, Loh E, Pilat M, Malburg L, Holloway S, Matthews N, Shackleton G, Valdivieso M, Lorusso P. A phase I trial of SR271425 given as a one hour infusion every 3 weeks to patients with advanced solid tumors Journal Of Clinical Oncology 2005, 23: 2030-2030. DOI: 10.1200/jco.2005.23.16_suppl.2030.
  • A phase I trial investigating a twice weekly administration of the oral taxane BMS-275183 in patients with advanced solid tumorsBroker L, Ruyter R, Voi M, Woo M, Astier L, Heath E, Lorusso P, Giaccone G. A phase I trial investigating a twice weekly administration of the oral taxane BMS-275183 in patients with advanced solid tumors Journal Of Clinical Oncology 2005, 23: 2040-2040. DOI: 10.1200/jco.2005.23.16_suppl.2040.
  • The effect of food on the pharmacokinetics of BMS-275183, a novel oral taxane, in patients with advanced solid malignanciesWoo M, Broker L, Pilat M, Malburg L, Cohen M, Griffin T, Valdivieso M, Giaccone G, Lorusso P. The effect of food on the pharmacokinetics of BMS-275183, a novel oral taxane, in patients with advanced solid malignancies Journal Of Clinical Oncology 2005, 23: 2053-2053. DOI: 10.1200/jco.2005.23.16_suppl.2053.
  • Clinical Development IssuesAverbuch S, Wolf M, El‐Rayes B, LoRusso P. Clinical Development Issues 2004, 287-306. DOI: 10.1002/047165616x.ch13.
  • The Role of Bisphosphonates in the Treatment of Skeletal Complications of Breast CancerEl-Rayes B, LoRusso P. The Role of Bisphosphonates in the Treatment of Skeletal Complications of Breast Cancer American Journal Of Cancer 2004, 3: 369-375. DOI: 10.2165/00024669-200403060-00004.
  • 501 Prospective UGT1A1 genotyping in a phase I study of safety and pharmacokinetics of liposome encapsulated SN-38 (LE-SN38)LoRusso P, Fishman M, Kraut E, Gordon M, Elsayed Y, Steinberg J, Nieves J, Wanaski S, Dul J, Sherman J. 501 Prospective UGT1A1 genotyping in a phase I study of safety and pharmacokinetics of liposome encapsulated SN-38 (LE-SN38) European Journal Of Cancer Supplements 2004, 2: 153. DOI: 10.1016/s1359-6349(04)80509-3.
  • Phase I trial of novel kinesin spindle protein (KSP) inhibitor SB-715992 IV days 1, 8, 15 q 28 daysBurris H, Lorusso P, Jones S, Guthrie T, Orr J, Williams D, Hodge J, Bush M, Sabry J. Phase I trial of novel kinesin spindle protein (KSP) inhibitor SB-715992 IV days 1, 8, 15 q 28 days Journal Of Clinical Oncology 2004, 22: 2004-2004. DOI: 10.1200/jco.2004.22.14_suppl.2004.
  • A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classificationTakimoto C, Saif M, Lorusso P, Sweeney C, Ducharme M, Chu S, Schwartz G, Danna M, De Jager R, Rowinsky E. A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification Journal Of Clinical Oncology 2004, 22: 2017-2017. DOI: 10.1200/jco.2004.22.14_suppl.2017.
  • Phase I clinical trial of XK469 in patients with chemo-refractory solid tumorsAlousi A, Parchment R, Boinpally R, Gadgeel S, Weigand R, McCormick J, Lorusso P. Phase I clinical trial of XK469 in patients with chemo-refractory solid tumors Journal Of Clinical Oncology 2004, 22: 2020-2020. DOI: 10.1200/jco.2004.22.14_suppl.2020.
  • Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancersSyed S, Beeram M, Takimoto C, Jakubowitz J, Kimura M, Ducharme M, Gadgeel S, De Jager R, Rowinsky E, Lorusso P. Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancers Journal Of Clinical Oncology 2004, 22: 2028-2028. DOI: 10.1200/jco.2004.22.14_suppl.2028.
  • Evaluation of a novel RNA biomarker of CDK2 inhibition in phase 1 clinical trials with BMS-387032Letrent S, Callegari F, Wong T, Burris H, Cohen R, Lorusso P, Papadimitrakopoulou V, Shapiro G, Griffin T, Decillis A. Evaluation of a novel RNA biomarker of CDK2 inhibition in phase 1 clinical trials with BMS-387032 Journal Of Clinical Oncology 2004, 22: 2031-2031. DOI: 10.1200/jco.2004.22.14_suppl.2031.
  • A phase I study of DX 8951f (exatecan mesylate for injection) in patients with renal dysfunctionSweeney C, Saif M, Lorusso P, Ducharme M, Demnati R, Danna M, Rowinsky E, Mita M, Dejager R, Takimoto C. A phase I study of DX 8951f (exatecan mesylate for injection) in patients with renal dysfunction Journal Of Clinical Oncology 2004, 22: 2069-2069. DOI: 10.1200/jco.2004.22.14_suppl.2069.
  • Pharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patientsKraut E, Fishman M, Lorusso P, Steinberg J, Nieves J, Fetterly G, Darling I, Wanaski S, Dul J, Sherman J. Pharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patients Journal Of Clinical Oncology 2004, 22: 2501-2501. DOI: 10.1200/jco.2004.22.14_suppl.2501.
  • Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancerRinehart J, Rothermel J, Anderson J, Lorusso P. Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer Journal Of Clinical Oncology 2004, 22: 3100-3100. DOI: 10.1200/jco.2004.22.14_suppl.3100.
  • Phase I trial of novel kinesin spindle protein (KSP) inhibitor SB-715992 IV days 1, 8, 15 q 28 daysBurris H, Lorusso P, Jones S, Guthrie T, Orr J, Williams D, Hodge J, Bush M, Sabry J. Phase I trial of novel kinesin spindle protein (KSP) inhibitor SB-715992 IV days 1, 8, 15 q 28 days Journal Of Clinical Oncology 2004, 22: 2004-2004. DOI: 10.1200/jco.2004.22.90140.2004.
  • A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classificationTakimoto C, Saif M, Lorusso P, Sweeney C, Ducharme M, Chu S, Schwartz G, Danna M, De Jager R, Rowinsky E. A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification Journal Of Clinical Oncology 2004, 22: 2017-2017. DOI: 10.1200/jco.2004.22.90140.2017.
  • Phase I clinical trial of XK469 in patients with chemo-refractory solid tumorsAlousi A, Parchment R, Boinpally R, Gadgeel S, Weigand R, McCormick J, Lorusso P. Phase I clinical trial of XK469 in patients with chemo-refractory solid tumors Journal Of Clinical Oncology 2004, 22: 2020-2020. DOI: 10.1200/jco.2004.22.90140.2020.
  • Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancersSyed S, Beeram M, Takimoto C, Jakubowitz J, Kimura M, Ducharme M, Gadgeel S, De Jager R, Rowinsky E, Lorusso P. Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancers Journal Of Clinical Oncology 2004, 22: 2028-2028. DOI: 10.1200/jco.2004.22.90140.2028.
  • Evaluation of a novel RNA biomarker of CDK2 inhibition in phase 1 clinical trials with BMS-387032Letrent S, Callegari F, Wong T, Burris H, Cohen R, Lorusso P, Papadimitrakopoulou V, Shapiro G, Griffin T, Decillis A. Evaluation of a novel RNA biomarker of CDK2 inhibition in phase 1 clinical trials with BMS-387032 Journal Of Clinical Oncology 2004, 22: 2031-2031. DOI: 10.1200/jco.2004.22.90140.2031.
  • A phase I study of DX 8951f (exatecan mesylate for injection) in patients with renal dysfunctionSweeney C, Saif M, Lorusso P, Ducharme M, Demnati R, Danna M, Rowinsky E, Mita M, Dejager R, Takimoto C. A phase I study of DX 8951f (exatecan mesylate for injection) in patients with renal dysfunction Journal Of Clinical Oncology 2004, 22: 2069-2069. DOI: 10.1200/jco.2004.22.90140.2069.
  • Pharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patientsKraut E, Fishman M, Lorusso P, Steinberg J, Nieves J, Fetterly G, Darling I, Wanaski S, Dul J, Sherman J. Pharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patients Journal Of Clinical Oncology 2004, 22: 2501-2501. DOI: 10.1200/jco.2004.22.90140.2501.
  • Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancerRinehart J, Rothermel J, Anderson J, Lorusso P. Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer Journal Of Clinical Oncology 2004, 22: 3100-3100. DOI: 10.1200/jco.2004.22.90140.3100.
  • In Vivo Methods for Screening and Preclinical TestingCorbett T, Polin L, LoRusso P, Valeriote F, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lisow L. In Vivo Methods for Screening and Preclinical Testing 2004, 99-123. DOI: 10.1007/978-1-59259-739-0_6.
  • 546 A phase I dose-escalation trial of ZD6126 administered as 5 daily dose every 3 weeks to patients with cancer refractory to other treatmentsBudd G, Evelhoch J, Langmuir P, Veiero J, Shepherdson K, LoRusso P. 546 A phase I dose-escalation trial of ZD6126 administered as 5 daily dose every 3 weeks to patients with cancer refractory to other treatments European Journal Of Cancer Supplements 2003, 1: s165. DOI: 10.1016/s1359-6349(03)90578-7.
  • 570 A phase I study to determine the safety and pharmacokinetics of intravenous administration of SB715992 on a once weekly for three consecutive weeks schedule in patients with refractory solid tumorsBurris H, LoRusso P, Jones S, McCormick J, Willcutt N, Hodge J, Bush P, Pandite L, Sabry J, Ho P. 570 A phase I study to determine the safety and pharmacokinetics of intravenous administration of SB715992 on a once weekly for three consecutive weeks schedule in patients with refractory solid tumors European Journal Of Cancer Supplements 2003, 1: s172-s173. DOI: 10.1016/s1359-6349(03)90602-1.
  • Pharmacodynamic Studies of the Epidermal Growth Factor Receptor Inhibitor ZD1839 in Skin From Cancer Patients: Histopathologic and Molecular Consequences of Receptor InhibitionAlbanell J, Rojo F, Averbuch S, Feyereislova A, Mascaro J, Herbst R, LoRusso P, Rischin D, Sauleda S, Gee J, Nicholson R, Baselga J. Pharmacodynamic Studies of the Epidermal Growth Factor Receptor Inhibitor ZD1839 in Skin From Cancer Patients: Histopathologic and Molecular Consequences of Receptor Inhibition Journal Of Clinical Oncology 2002, 20: 110-124. DOI: 10.1200/jco.2002.20.1.110.
  • Pharmacodynamic studies of the specific oral EGFR tyrosine kinase inhibitor (EGFR-TKI) zd1839 (‘Iressa’) in skin from cancer patients participating in phase I trials: histopathological and molecular consequences of receptor inhibitionAlbanell J, Rojo F, Averbuch S, Feyereislova A, Herbst R, LoRusso P, Rischin D, Gee J, Nicholson R, Baselga J. Pharmacodynamic studies of the specific oral EGFR tyrosine kinase inhibitor (EGFR-TKI) zd1839 (‘Iressa’) in skin from cancer patients participating in phase I trials: histopathological and molecular consequences of receptor inhibition European Journal Of Cancer 2001, 37: s159. DOI: 10.1016/s0959-8049(01)81071-6.
  • Objective regressions in non-small cell lung cancer patients treated in Phase I trials of oral ZD1839 (IressaTM), a selective tyrosine kinase inhibitor that blocks the epidermal growth factor receptor (EGFR)Kris M, Herbst R, Rischin D, LoRusso P, Baselga J, Hammond L, Feyereislova A, Ochs J, Averbuch S. Objective regressions in non-small cell lung cancer patients treated in Phase I trials of oral ZD1839 (IressaTM), a selective tyrosine kinase inhibitor that blocks the epidermal growth factor receptor (EGFR) Lung Cancer 2000, 29: 72. DOI: 10.1016/s0169-5002(00)80233-0.
  • In Vivo Methods for Screening and Preclinical TestingCorbett T, Valeriote F, LoRusso P, Polin L, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lisow L. In Vivo Methods for Screening and Preclinical Testing 1997, 75-99. DOI: 10.1007/978-1-4615-8152-9_5.
  • Tumor Models and the Discovery and Secondary Evaluation of Solid Tumor Active AgentsCorbett T, Valeriote F, Lorusso P, Polin L, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lowichik N, Biernat L, Foster B, Wozniak A, Lisow L, Valdivieso M, Baker L, Leopold W, Sebolt J, Bissery M, Mattes K, Dzubow J, Rake J, Perni R, Wentland M, Coughlin S, Shaw J, Liversidge G, Liversidge E, Bruno J, Sarpotdar P, Moore R, Patterson G. Tumor Models and the Discovery and Secondary Evaluation of Solid Tumor Active Agents Pharmaceutical Biology 1995, 33: 102-122. DOI: 10.3109/13880209509067092.
  • Discovery of Anticancer Agents from Natural ProductsValeriote F, Corbett T, Lorusso P, Moore R, Scheuer P, Patterson G, Paul V, Grindey G, Bonjouklian R, Pearce H, Suffness M. Discovery of Anticancer Agents from Natural Products Pharmaceutical Biology 1995, 33: 59-66. DOI: 10.3109/13880209509067088.
  • Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analoguesCorbett T, Lowichik N, Pugh S, Polin L, Panchapor C, White K, Knight J, Demchik L, Jones J, Jones L, Biernat L, Lorusso P, Foster B, Heilbrun L, Rake J, Mattes K, Perni R, Powles R, Hlavac A, Wentland M, Coughlin S, Baker L, Valeriote F. Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues Expert Opinion On Investigational Drugs 1994, 3: 1281-1292. DOI: 10.1517/13543784.3.12.1281.

Clinical Trials

ConditionsStudy Title
Phase IA Phase 1 Study of ASP3082 in Participants With Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation
Phase IOpen Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 With Dose Expansion Phase, in Subjects With Advanced Solid Tumors
Phase IA Phase 1 Study of HMBD-002-V4C26 (HMBD-002), a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Malignancies
Phase IA Phase 1B, Open-Label, Dose-Escalation Study of the Safety of and Antigen-specific Immune Responses Elicited by VB10.NEO in Combination With Atezolizumab in Patients With Locally Advanced and Metastatic Tumors
Phase IA Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors
Phase IPhase Ib/II Study of ZEN003694 and Entinostat in Advanced and Refractory Solid Tumors and Lymphomas
Phase IA Phase 1a/1b Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors
Phase IA Phase 1/2, Dose Escalation and Expansion Study of the Safety, Tolerability, and Anti-tumor Activity of BND-22 Administered Alone and in Combination With Pembrolizumab or With Cetuximab in Patients With Advanced Solid Tumors
Phase IA Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors
Phase IA Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CM24 in Combination With Nivolumab in Adults With Advanced Solid Tumors
Phase IA Phase 1, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 as Monotherapy in Patients With Selected Advanced Solid Tumors
Phase IA Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO-100 in Adult Patients With Advanced Solid Tumors
Phase IA Phase 1 Dose Escalation and Expansion Study of ABL503, a Bispecific Antibody of 4-1BB and PD-L1, as a Single Agent in Subjects With Any Progressive Locally Advanced (Unresectable) or Metastatic Solid Tumors
Phase IPhase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 in Patients With Advanced Solid Tumors (MYTHIC Study)
Phase IA Phase 1/2 Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
Phase IPhase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients With Molecularly Selected Cancers (ATTACC)
LungBAY1895344 Plus Topoisomerase-1 (Top1) Inhibitors in Patients With Advanced Solid Tumors, Phase I Studies With Expansion Cohorts in Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) and Pancreatic Adenocarcinoma (PDA)
Phase IPhase I, First-in-human, Open-label, Dose Escalation Trial to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of BNT152+153 in Patients With Solid Tumors
Phase IPhase 1 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumor Malignancies
Phase IA First-in-human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects With Advanced Solid Tumors