At a glance
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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
In Brief
A Phase 2 clinical trial evaluating CPI-1205, Cobicistat, and 3 other interventions for Metastatic Castration Resistant Prostate Cancer (mCRPC). Completed, enrolled 175 participants across 41 sites.
Detailed Summary
This was an open-label Phase 1b/2 study involving oral administration of CPI-1205 in combination with either enzalutamide or abiraterone/prednisone in male patients with metastatic Castration-Resistant Prostate Cancer. The study was designed to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) based on the safety, tolerability, pharmacokinetic, and efficacy profiles of CPI-1205 in combination with either enzalutamide or abiraterone/prednisone. Following the determination of the MTD and RP2D, the study proceeded to Phase 2. Patients in Phase 2 received CPI-1205 at the RP2D in combination with either enzalutamide or abiraterone/prednisone versus either enzalutamide or abiraterone/prednisone as a control arm.
Study Details
Timeline
Interventions
CPI-1205: Either 400 mg BID or 800 mg TID during Phase 1 dose-escalation and RP2D, 800 mg TID, for Phase 2
Cobicistat 150 mg PO BID
Enzalutamide 160mg PO QD
Abiraterone 1000mg PO QD
Prednisone 5mg PO BID