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Completed Phase 1Phase 2 Interventional Results available

ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer

ClinicalTrials.gov ID: NCT03480646

Public ClinicalTrials.gov record NCT03480646. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 6:58 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03480646
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Constellation Pharmaceuticals
Industry
Enrollment
175 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 15, 2017 (Actual)
Primary completion
Feb 3, 2021 (Actual)
Completion
Feb 3, 2021 (Actual)
Last update posted
Oct 29, 2025

2017 – 2021

United States locations

U.S. sites
41
U.S. states
21
U.S. cities
37
Facility City State ZIP Site status
Alaska Urological Institute Anchorage Alaska 99503 —
Beverly Hills Cancer Center (BHCC) Beverly Hills California 90211 —
John Wayne Cancer Inst. Duarte California 91010 —
UCLA Los Angeles California 90095 —
Rocky Mountain Cancer Centers Aurora Colorado 80045 —
University of Colorado Hospital - Anschutz Cancer Pavilion Aurora Colorado 80045 —
University of Florida Jacksonville Florida 32209 —
Mount Sinai Comprehensive Cancer Center Miami Florida 33140 —
H. Lee Moffitt Cancer Center & Research Institute Tampa Florida 33612 —
Rush University Medical Center Chicago Illinois 60612 —
University of Illinois Hospital and Health Systems Chicago Illinois 60612 —
Indiana University- Simon Cancer Center Indianapolis Indiana 46202 —
Tulane University Health Sciences Center New Orleans Louisiana 70112 —
University of Maryland Baltimore Maryland 21201 —
John Hopkins Kimmel Cancer Center Baltimore Maryland 21205 —
Maryland Oncology Hematology Rockville Maryland 20850 —
Dana Farber Cancer Institute Boston Massachusetts 02115 —
Henry Ford Health System Detroit Michigan 48202 —
GU Research Network Omaha Nebraska 68130 —
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89135 —
New Mexico Cancer Center Albuquerque New Mexico 87106 —
Roswell Park Comprehensive Cancer Center Buffalo New York 14263 —
North Shore Hematology Oncology Associates East Setauket New York 11733 —
NYU Langone Medical Center Laura and Isaac Permlutter Cancer Center New York New York 10016 —
Icahn School of Medicine at Mt. Sinai New York New York 10029 —
Eastchester Center for Cancer Care The Bronx New York 10469 —
University of North Carolina-Chapel Hill Chapel Hill North Carolina 27599 —
Levine Cancer Institute Charlotte North Carolina 28204 —
Duke University Medical Center Durham North Carolina 22710 —
Ohio State University - James Cancer Hospital and Solove Research Institute Columbus Ohio 43210 —
Toledo Clinic Cancer Center Toledo Ohio 43623 —
Williamette Valley Cancer Institute and Research Center Eugene Oregon 97401 —
Compass Oncology - East Tualatin Oregon 97062 —
St. Luke's University Bethlehem Pennsylvania 18015 —
Gettysburg Cancer Center Gettysburg Pennsylvania 17331 —
Greenville Hospital System, Institute for Translational Oncology Research Greenville South Carolina 29605 —
Carolina Urologic Research Center Myrtle Beach South Carolina 29572 —
Texas Oncology - Central Austin Cancer Center Austin Texas 78731 —
Texas Oncology- Fort Worth Fort Worth Texas 76104 —
Texas Oncology- Tyler Tyler Texas 75702 —
Virginia Oncology Associates Hampton Virginia 23666 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03480646, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 29, 2025 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03480646 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →