2012
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.Peer-Reviewed Original ResearchPhase 2 doseIncurable breast cancerBreast cancerAndrogen receptorDay 1PK samplesDay 8Dose-escalation stageOverall survival benefitDose-escalation studyPhase 1 studyAR nuclear translocationInhibition of androgenPotential therapeutic strategyPK samplingAdverse eventsDaily dosingSurvival benefitAR expressionHistologic subtypeDiscontinuation criteriaPreclinical activityProstate cancerTumor assessmentMDV3100
2006
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.Peer-Reviewed Original ResearchConsecutive daily dosesAdvanced solid tumorsDaily dosesSolid tumorsSingle doseReceptor tyrosine kinasesSmall-molecule MET inhibitorTerminal half-life valuesGrade 2 hypertensionPapillary renal cell carcinomaSystemic drug exposurePeak plasma levelsRenal cell carcinomaTumor-associated vasculatureHepatocyte growth factor receptorGrowth factor receptorPharmacokinetic samplingPK samplingPartial responseRepeat dosingCell carcinomaMinor responsePlasma levelsDrug exposureMET inhibitors