2012
A phase III, randomized, double-blind, multicenter trial comparing the investigational agent orteronel (TAK-700) plus prednisone (P) with placebo plus P in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy.
Dreicer R, Agus D, Bellmunt J, De Bono J, Petrylak D, Tejura B, Shi Y, Fizazi K. A phase III, randomized, double-blind, multicenter trial comparing the investigational agent orteronel (TAK-700) plus prednisone (P) with placebo plus P in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy. Journal Of Clinical Oncology 2012, 30: tps4693-tps4693. DOI: 10.1200/jco.2012.30.15_suppl.tps4693.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerDisease progressionRadiographic progression-free survivalProstate-specific antigen levelCastration-resistant prostate cancerChemotherapy-naïve menDocetaxel-based therapyPhase 1/2 studyPhase 3 studyProgression-free survivalPatient-reported outcomesNew therapeutic optionsTestosterone synthesis pathwayERG fusion geneBone painMedical castrationNoncurative therapyHormonal therapyPrimary endpointPSA decreasePSA progressionStudy drugMetastatic diseaseObjective responseOverall survival
2007
Phase II multicenter, two-stage study of E7389 in patients with hormone refractory prostate cancer with advanced and/or metastatic disease stratified by prior chemotherapy
Molife R, Cartwright T, Loesch D, Garbo L, Sonpavde G, Calvo E, Das A, Wanders J, Petrylak D, de Bono J. Phase II multicenter, two-stage study of E7389 in patients with hormone refractory prostate cancer with advanced and/or metastatic disease stratified by prior chemotherapy. Journal Of Clinical Oncology 2007, 25: 15513-15513. DOI: 10.1200/jco.2007.25.18_suppl.15513.Peer-Reviewed Original ResearchHormone-refractory prostate cancerRefractory prostate cancerPSA responsePrior chemotherapyProstate cancerNon-small cell lung cancerSmall cell lung cancerPhase II multicenterRefractory breast cancerSerious adverse eventsSingle-agent activityCell lung cancerProstate cancer cell linesBolus IV infusionTwo-stage studyConcomitant steroidsCancer cell linesChest painFebrile neutropeniaStudy drugAcceptable toxicityMetastatic diseasePrior regimenRenal failureAdverse events