2019
ARCHES: Efficacy of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC).
Armstrong A, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore N, Rosbrook B, Baron B, Chen L, Stenzl A. ARCHES: Efficacy of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC). Journal Of Clinical Oncology 2019, 37: 5048-5048. DOI: 10.1200/jco.2019.37.15_suppl.5048.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerAndrogen deprivation therapyCastration-resistant prostate cancerAdverse eventsSecondary endpointsOverall survivalProstate cancerNonmetastatic castration-resistant prostate cancerHormone-sensitive prostate cancerPrior androgen deprivation therapyRadiographic progression-free survivalEfficacy of enzalutamideHigh-volume diseasePrior docetaxel usePrior treatment subgroupsPre-specified subgroupsProgression-free survivalPhase 3 studyUnexpected adverse eventsNew antineoplastic therapiesDocetaxel useDeprivation therapyEfficacy endpointPrimary endpointPrior therapyPhase III study of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): The ARCHES trial.
Armstrong A, Szmulewitz R, Petrylak D, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore N, Rosbrook B, Sugg J, Baron B, Chen L, Stenzl A. Phase III study of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): The ARCHES trial. Journal Of Clinical Oncology 2019, 37: 687-687. DOI: 10.1200/jco.2019.37.7_suppl.687.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerRadiographic progression-free survivalAndrogen deprivation therapyCastration-resistant prostate cancerAdverse eventsPrior docetaxelSecondary endpointsDisease volumeOverall survivalProstate cancerNonmetastatic castration-resistant prostate cancerHormone-sensitive prostate cancerProstate-specific antigen progressionEfficacy of enzalutamideHigh-volume diseasePhase 3 studyProgression-free survivalAndrogen receptor inhibitorUnexpected adverse eventsSimilar significant improvementsDeprivation therapyEfficacy endpointPrimary endpointTreatment discontinuationBaseline characteristics
2006
Pharmacokinetics (PK), safety and tolerability of atrasentan (ABT-627, ATN) in combination with docetaxel (DOC) in men with hormone refractory prostate cancer (HRPC)
Petrylak D, Mohile S, Shelton G, Carr R, Steinberg J, Sleep D, Melia J, Rieser M, Nanus D, Milowsky M. Pharmacokinetics (PK), safety and tolerability of atrasentan (ABT-627, ATN) in combination with docetaxel (DOC) in men with hormone refractory prostate cancer (HRPC). Journal Of Clinical Oncology 2006, 24: 14512-14512. DOI: 10.1200/jco.2006.24.18_suppl.14512.Peer-Reviewed Original ResearchHormone-refractory prostate cancerPSA declineAdverse eventsTreatment of HRPCPhase III clinical developmentPhase III studyRefractory prostate cancerUnexpected adverse eventsDOC infusionNeutropenic feverIII studyLiver metastasesOral dosesPO QDSelective endothelinPK interactionsReceptor antagonistPlasma concentrationsProstate cancerCYP3A4 activityClinical developmentDay 1DocetaxelPK resultsPharmacokinetics