Clinical Trials Search
ProSTAR: A Phase 1b/2 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, Combined with Enzalutamide or Abiraterone/Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer
Phase 1b Dose Escalation Primary Objective: To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of CPI-1205 + enzalutamide and CPI-1205 + abiraterone/prednisone in patients with metastatic castration resistant prostate cancer (mCRPC). Phase 1b HPEC(s) Primary Objective: To estimate objective response rate (ORR) as determined by central radiology review (CRR) of CPI-1205 (with or without cobicistat) + enzalutamide OR abiraterone/prednisone in the HPEC. Randomized Phase 2 Primary Objective: To evaluate the effect of CPI-1205 (with or without cobicistat) + enzalutamide OR abiraterone/prednisone (combination arm) versus(vs) enzalutamide OR abiraterone/prednisone alone (control arm) in patients with mCRPC.