2019
891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)
Petrylak D, Li B, Schloss C, Fizazi K. 891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Annals Of Oncology 2019, 30: v351. DOI: 10.1093/annonc/mdz248.048.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPrednisone/prednisoloneAndrogen deprivation therapySubsidiary of MerckDohme Corp.Merck SharpKey secondary efficacy end pointsRadiographic progression-free survivalRandomized phase 3 trialSecondary efficacy end pointsCastration-resistant prostate cancerAdequate organ functionECOG PS 0/1Subsequent anticancer therapyEfficacy end pointPhase 3 trialProgression-free survivalRadiographic disease progressionCT/MRIBristol-Myers SquibbAdult ptsDeprivation therapyPS 0/1RECIST v1.1Unacceptable toxicity
2013
A phase I/II study of safety and efficacy of orteronel (TAK-700), an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC): Updated phase II results.
Petrylak D, Gandhi J, Clark W, Heath E, Lin J, Oh W, Agus D, Carthon B, Moran S, Kong N, Suri A, Bargfrede M, Liu G. A phase I/II study of safety and efficacy of orteronel (TAK-700), an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC): Updated phase II results. Journal Of Clinical Oncology 2013, 31: 59-59. DOI: 10.1200/jco.2013.31.6_suppl.59.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPSA responseMedian timePhase I/II studyCastration-resistant prostate cancerDrug-related SAEsECOG PS 0/1Good PSA responseProgression of PsAPhase 1/2 studyPartial tumor responsePhase II resultsBlood alkaline phosphataseCastrate menPS 0/1Median PSAPrior chemotherapyPSA declinePSA progressionRadiologic progressionRECIST 1.1Data cutoffII studyRadiographic diseaseSerum PSA
2012
918P Phase 2 Results from a Phase 1/2 Study of Tak-700 (ORTERONEL), An Oral, Investigational, Nonsteroidal 17,20-Lyase Inhibitor, with Docetaxel and Prednisone (DP) in Metastatic Castration-Resistant Prostate Cancer (MCRPC)
Petrylak D, Gandhi J, Clark W, Heath E, Lin J, Oh W, Agus D, Carthon B, Moran S, Liu G. 918P Phase 2 Results from a Phase 1/2 Study of Tak-700 (ORTERONEL), An Oral, Investigational, Nonsteroidal 17,20-Lyase Inhibitor, with Docetaxel and Prednisone (DP) in Metastatic Castration-Resistant Prostate Cancer (MCRPC). Annals Of Oncology 2012, 23: ix302-ix303. DOI: 10.1016/s0923-7534(20)33476-1.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPhase 1/2 studyTAK-700Febrile neutropeniaMedian timeCastration-resistant prostate cancerDrug-related SAEsECOG PS 0/1Good PSA responseProgression of PsAPSA response rateTreatment-related AEsPartial tumor responseLyase inhibitorMillennium PharmaceuticalsGlaxo Smith KlineCastrate menEvaluable populationPrior chemotherapyPS 0/1PSA declinePSA progressionRadiologic progressionRECIST 1.1Data cutoffPhase I results from a phase I/II study of orteronel, an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC).
Petrylak D, Gandhi J, Clark W, Heath E, Lin J, Oh W, Agus D, Kucuk O, Moran S, Wang J, Bargfrede M, Liu G. Phase I results from a phase I/II study of orteronel, an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2012, 30: 4656-4656. DOI: 10.1200/jco.2012.30.15_suppl.4656.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerSerious AEsFebrile neutropeniaCohort 1Phase I/II studyCastration-resistant prostate cancerCommon serious AEsECOG PS 0/1Median age 68Median PSA declinePhase 1/2 studyPhase II portionLyase inhibitorCastrate menPS 0/1Measurable diseaseMedian PSAPrior chemotherapyPSA declineII studyInfusion reactionsNeutrophil countStandard chemotherapyDose escalationWBC count