ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer
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.
Timeline
- Start
- 2017-11-15
- Primary completion
- 2021-02-03
- Completion
- 2021-02-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 100 mg | Oral |
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | CPI-1205 | Small molecule | 400 mg | Oral |
| Subject | CPI-1205 | Small molecule | 800 mg | Oral |
| Background | Cobicistat | Small molecule | 150 mg | Oral |
| Background | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |