2023
126P Evaluation of myeloid targeting agents, PY159 and PY314, in two dose expansion phase Ib trials in platinum-resistant ovarian cancer
Yeku O, Barve M, Tan W, Wang J, Patnaik A, Lorusso P, Naqash A, Dowlati A, Fu S, Gordon M, Hubbard J, Kummar S, Kyriakopoulos C, Schenk E, Deegan D, Liang L, Li Y, Reyno L, Chamberlain M, Winer I. 126P Evaluation of myeloid targeting agents, PY159 and PY314, in two dose expansion phase Ib trials in platinum-resistant ovarian cancer. Immuno-Oncology Technology 2023, 20: 100598. DOI: 10.1016/j.iotech.2023.100598.Peer-Reviewed Original ResearchA pilot study of volumetric and density tumor analysis of ACC patients treated with vorinostat in a phase II clinical trial
Malarkey M, Toscano A, Bagheri M, Solomon J, Machado L, LoRusso P, Chen A, Folio L, Goncalves P. A pilot study of volumetric and density tumor analysis of ACC patients treated with vorinostat in a phase II clinical trial. Heliyon 2023, 9: e18680. PMID: 37593628, PMCID: PMC10428039, DOI: 10.1016/j.heliyon.2023.e18680.Peer-Reviewed Original ResearchACC patientsClinical trialsTarget lesionsSolid tumorsPhase II clinical trialPilot studyPhase 2 trialResponse Evaluation CriteriaSalivary gland cancerRare salivary gland cancerSystemic therapy efficacyStable diseaseGland cancerLung lesionsComputed tomography (CT) examsCystic carcinomaTherapy responseBlinded observersTomography examsTherapy efficacyLesionsInter-observer variationPatientsAppropriate evaluationTrials
2022
Improving precision oncology through better designs and reporting of biomarker-driven randomized clinical trials
LoRusso P, Freidlin B. Improving precision oncology through better designs and reporting of biomarker-driven randomized clinical trials. Journal Of The National Cancer Institute 2022, 115: 122-124. PMID: 36448688, PMCID: PMC9905964, DOI: 10.1093/jnci/djac212.Peer-Reviewed Original Research732MO 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
Champiat 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.Peer-Reviewed Original Research
2021
The impact of COVID-19 on cancer care and oncology clinical research: an experts’ perspective
Sessa C, Cortes J, Conte P, Cardoso F, Choueiri T, Dummer R, Lorusso P, Ottmann O, Ryll B, Mok T, Tempero M, Comis S, Oliva C, Peters S, Tabernero J. The impact of COVID-19 on cancer care and oncology clinical research: an experts’ perspective. ESMO Open 2021, 7: 100339. PMID: 34953404, PMCID: PMC8608656, DOI: 10.1016/j.esmoop.2021.100339.Peer-Reviewed Original ResearchConceptsInnovative clinical trialsClinical trialsOncology clinical trialsOncology clinical researchClinical researchCancer careClinical trial stakeholdersTrial stakeholdersNew treatmentsPatient accessCancer clinical trialsCOVID-19COVID-19 pandemicNew trial designsFaster patient accessWorldwide clinical trialsClinical trial objectivesOncology expertsOutcome dataTrial designTrial objectivesTrialsRecent dataCareInternational panel958O Coordinated activation of antitumor responses of g9d2 and CD8 T-cells by targeting BTN3A with ICT01 in patients with solid tumors: EVICTION trial
Marabelle 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.Peer-Reviewed Original ResearchMO24-1 Phase I/IIa trial evaluating safety and clinical activity of DuoBody®-PD-L1×4-1BB (GEN1046) in advanced solid tumors
Melero 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.Peer-Reviewed Original Research
2020
Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center
Hong 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.Peer-Reviewed Original Research
2018
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
Plummer 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.Peer-Reviewed Original ResearchPreliminary 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.Peer-Reviewed Original Research
2017
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.Peer-Reviewed Original Research235TiP A Phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumours, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/-endocrine therapy), or non-small-cell lung cancer (NSCLC)
Prat A, Yee D, Sablin M, Iwata H, Johnston E, Bogenrieder T, Serra J, Stucke-Straub K, Russo P. 235TiP A Phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumours, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/-endocrine therapy), or non-small-cell lung cancer (NSCLC). Annals Of Oncology 2017, 28: v72-v73. DOI: 10.1093/annonc/mdx364.017.Peer-Reviewed Original Research
2016
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.Peer-Reviewed Original Research
2007
Barriers to phase I clinical trial protocol IRB approval at KCI
Wang 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.Peer-Reviewed Original ResearchInstitutional review boardClinical trialsIRB approvalMedian timePhase 1 clinical trialPhase 1 trialPhase 1 protocolPatient accrualAnti-cancer drug developmentStudy designProtocol approvalReview boardFinal approvalPhase IDrug development processSignificant financial relationshipTrialsApproval statusAverage timeHuman subjectsDrug developmentMolecular therapeuticsApprovalInitial review
2005
A phase I trial investigating a twice weekly administration of the oral taxane BMS-275183 in patients with advanced solid tumors
Broker 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.Peer-Reviewed Original Research
2004
Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer
Rinehart 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.Peer-Reviewed Original ResearchPhase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer
Rinehart 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.Peer-Reviewed Original Research
2003
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
Budd 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.Peer-Reviewed Original Research
1999
Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan Detroit
Simon M, Brown D, Du W, LoRusso P, Kellogg C. Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan Detroit. American Journal Of Clinical Oncology 1999, 22: 42-46. PMID: 10025379, DOI: 10.1097/00000421-199902000-00011.Peer-Reviewed Original ResearchConceptsBreast cancer clinical trialsClinical trialsCancer clinical trialsBreast cancerLarge urban university hospitalFemale breast cancer patientsEarly-stage diseaseUrban university hospitalBreast cancer patientsAvailable studiesUniversity Affiliated HospitalStage diseasePatient barriersMedical oncologistsBreast servicesPatient enrollmentCancer patientsPatient raceUniversity HospitalPractice patternsMost womenTrialsWomenEnrollment processMetropolitan Detroit
1994
Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues
Corbett 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.Peer-Reviewed Original ResearchLiver toxicityAntitumour activityClinical trialsPhase I clinical trialSevere liver toxicityEfficacious dose levelsPreclinical modelsDose levelsBetter efficacyWeekly scheduleAntischistosomal agentsDay scheduleHycanthoneM2 levelToxicityTrialsMost analoguesAgentsRecovery timeVariety of analoguesGroupActivityMiceDose