ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer
Completed · Phase 1/Phase 2
Conditions studied: Metastatic Castration Resistant Prostate Cancer (mCRPC)
In brief
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.
Key facts
- Study ID
- NCT03480646
- Run by
- Constellation Pharmaceuticals
- People needed
- 175
- Starts
- 2017-11-15
- Expected to finish
- 2021-02-03
- Last updated by the study team
- 2025-10-29
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Alaska Urological Institute — Anchorage, Alaska, United States
- Beverly Hills Cancer Center (BHCC) — Beverly Hills, California, United States
- John Wayne Cancer Inst. — Duarte, California, United States
- UCLA — Los Angeles, California, United States
- Rocky Mountain Cancer Centers — Aurora, Colorado, United States
- University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado, United States
- University of Florida — Jacksonville, Florida, United States
- Mount Sinai Comprehensive Cancer Center — Miami, Florida, United States
- H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
- Rush University Medical Center — Chicago, Illinois, United States
- University of Illinois Hospital and Health Systems — Chicago, Illinois, United States
- Indiana University- Simon Cancer Center — Indianapolis, Indiana, United States
- Tulane University Health Sciences Center — New Orleans, Louisiana, United States
- University of Maryland — Baltimore, Maryland, United States
- John Hopkins Kimmel Cancer Center — Baltimore, Maryland, United States
- Maryland Oncology Hematology — Rockville, Maryland, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Henry Ford Health System — Detroit, Michigan, United States
- GU Research Network — Omaha, Nebraska, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- New Mexico Cancer Center — Albuquerque, New Mexico, United States
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
- North Shore Hematology Oncology Associates — East Setauket, New York, United States
- NYU Langone Medical Center Laura and Isaac Permlutter Cancer Center — New York, New York, United States
- Icahn School of Medicine at Mt. Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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