2024
Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103)
Garralda E, Oh Y, Italiano A, Bedard P, Delord J, Calvo E, LoRusso P, Wainberg Z, Cervantes A, Rodriguez‐Vida A, Shemesh C, Sane R, Mendus D, Ding H, Hendricks R, Meng R, Cho B, Kim T, Wu B. Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103). The Journal Of Clinical Pharmacology 2024, 64: 544-554. PMID: 38105505, DOI: 10.1002/jcph.2397.Peer-Reviewed Original ResearchSolid tumorsMixed solid tumorsDose-proportional mannerDrug-drug interactionsSlower elimination phaseSequential dosingInter-individual variabilityIntravenous infusionSystemic exposureImmunogenicity assessmentAtezolizumabHuman studiesElimination phasePK dataPK profilesPK propertiesPatientsMonoclonal antibodiesSerum samplesPharmacokineticsDays/Multiple timepointsSingle timepointGeometric meanQ4W
2020
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
Puzanov 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.Peer-Reviewed Original Research
2016
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.Peer-Reviewed Original Research
2015
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.Peer-Reviewed Original Research
2014
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.Peer-Reviewed Original ResearchRelationship 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.Peer-Reviewed Original Research10P A Phase 1 Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enzalutamide Alone or Combined with an Aromatase Inhibitor in Women with Advanced Breast Cancer
Traina T, Yardley D, Patel M, Schwartzberg L, Elias A, Gucalp A, Blaney M, Gibbons J, Hudis C, LoRusso P. 10P A Phase 1 Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enzalutamide Alone or Combined with an Aromatase Inhibitor in Women with Advanced Breast Cancer. Annals Of Oncology 2014, 25: i4. DOI: 10.1093/annonc/mdu064.1.Peer-Reviewed Original Research
2012
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
Haluska 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.Peer-Reviewed Original Research
2010
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
Ratain 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.Peer-Reviewed Original Research383 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
Britten 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.Peer-Reviewed Original ResearchA 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.Peer-Reviewed Original Research
2009
Phase I evaluation of lapatinib and everolimus in patients with advanced malignancies: Southwest Oncology Group trial S0528
Hoban 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.Peer-Reviewed Original ResearchLapatinib 1250Oral inhibitorCombination of lapatinibMedian age 63Phase I evaluationPre-clinical studiesPI3/Akt pathwayAnti-tumor activityEligible ptsStable diseaseAdvanced malignanciesAdvanced tumorsLung cancerCommon tumorsEffective therapyPharmacokinetic analysisI evaluationEverolimusAge 63Drug pharmacokineticsPharmacokineticsMTDPhase ILapatinibAkt pathway
2008
223 POSTER Pharmacokinetics and pharmacodynamic biomarkers for the pan-PI3K inhibitor GDC-0941: Initial Phase I evaluation
LoRusso 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.Peer-Reviewed Original Research429 POSTER Phase 1 study of food effects on pharmacokinetics of brivanib alaninate in patients with advanced or metastatic solid tumors
Hurwitz 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.Peer-Reviewed Original Research216 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
Markman 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.Peer-Reviewed Original ResearchA 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
Papadopoulos 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.Peer-Reviewed Original Research
2005
Pharmacokinetics (PK) and pharmacodynamics (PD) of PD 0325901, a second generation MEK inhibitor after multiple oral doses of PD 0325901 to advanced cancer patients
Menon 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.Peer-Reviewed Original ResearchThe effect of food on the pharmacokinetics of BMS-275183, a novel oral taxane, in patients with advanced solid malignancies
Woo 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.Peer-Reviewed Original Research
2003
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
Burris 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.Peer-Reviewed Original Research