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

NCT03480646 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2025-10-29

Study results available
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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.

Conditions

  • Metastatic Castration Resistant Prostate Cancer (mCRPC)

Interventions

DRUG

CPI-1205

CPI-1205: Either 400 mg BID or 800 mg TID during Phase 1 dose-escalation and RP2D, 800 mg TID, for Phase 2

DRUG

Cobicistat

Cobicistat 150 mg PO BID

DRUG

Enzalutamide

Enzalutamide 160mg PO QD

DRUG

Abiraterone

Abiraterone 1000mg PO QD

DRUG

Prednisone

Prednisone 5mg PO BID

Sponsors & Collaborators

  • Constellation Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2021-02-03
Completion
2021-02-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03480646 on ClinicalTrials.gov