2013
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.Peer-Reviewed Original ResearchNon-small cell lung cancerEpithelial ovarian cancerStudy drug-related serious adverse eventsAdverse eventsEndometrial cancerDose escalationDose levelsSolid tumorsAntibody-drug conjugatesRefractory non-small cell lung cancerDrug-related serious adverse eventsRefractory epithelial ovarian cancerResistant epithelial ovarian cancerClear cell renal cell cancerSerous epithelial ovarian cancerFLT-PET imagingPhase 2 doseSerious adverse eventsRefractory solid tumorsAccelerated titration designCell lung cancerRenal cell cancerPrimary study objectiveEvaluation of safetyGCIG criteria
2012
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.Peer-Reviewed Original ResearchTopoisomerase I inhibitorDay scheduleCell lungTreatment-emergent adverse eventsNon-small cell lungEmergent adverse eventsPhase I safetyAdvanced solid tumorsAccelerated titration designPK-PD relationshipSmall cell lungDistinct clinical profileDose-exposure relationshipPharmacokinetic-pharmacodynamic modelI inhibitorNon-camptothecin topoisomerase I inhibitorsStable diseaseI safetyAdverse eventsPhase I developmentWeekly dosesClinical profileEfficacy dataTitration designSafety data