Prostate Cancer Clinical Trial

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

Summary

This is a two-arm, open label Phase 1b/2 study with an oral administration of CPI-1205 in combination with either enzalutamide or abiraterone/prednisone in male patients with metastatic Castration Resistant Prostate Cancer. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of CPI-1205 in combination with either enzalutamide or abiraterone/prednisone.

Following determination of MTD and RP2D will proceed to phase 2. Patients in phase 2 will receive CPI-1205 at the RP2D in combination with either enzalutamide or abiraterone/prednisone vs either enzalutamide or abiraterone/prednisone as a control arm.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adults (Age ≥ 18 years)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Life expectancy of at least 12 weeks
Histologically or cytologically confirmed adenocarcinoma of the prostate
Progressive disease in the setting of medical or surgical castration (i.e. CRPC)
Documented metastatic disease
Must have undergone bilateral orchiectomy (surgical castration) or be willing to continue gonadotropin-releasing hormone (GnRH) analog or antagonist (medical castration)
Serum testosterone <50 ng/dL
Receipt of prior line of second generation androgen inhibitor

Demonstrate adequate organ function as defined below:

Absolute Neutrophil Count (ANC) ≥ 1,000/μL
Platelet Count ≥ 100,000/μL
Hemoglobin (Hgb) ≥ 8 g/dL
Serum creatinine ≤ 2 × upper limit of normal (ULN) OR
Creatinine clearance (CrCl) ≥ 40 mL/min as estimated by the Cockcroft and Gault formula1 in subjects with creatinine > 2 X ULN
Bilirubin ≤ 1.5 × ULN unless evidence of Gilbert's disease in which case < 3 x ULN
Aspartate aminotransferase (AST) ≤ 2.5 × ULN without liver metastases; must be ≤ 5 × ULN with liver metastases
Alanine aminotransferase (ALT) ≤ 2.5 × ULN without liver metastases; must be ≤ 5 × ULN with liver metastases

Exclusion Criteria:

Known symptomatic brain metastases (NOTE: patients with treated epidural disease are allowed)

Treatment with any of the following for prostate cancer within the indicated timeframe prior to day 1 of treatment:

First generation: AR antagonists (e.g., bicalutamide, nilutamide, flutamide) within 4 weeks
5 alpha reductase inhibitors, ketoconazole, estrogens (including diethylstilbesterol [DES]), or progesterones within 2 weeks
Chemotherapy within 3 weeks
Biologic therapy within 4 weeks
Investigational therapy within 3 weeks (or within a time interval less than at least 5 half-lives of the investigational agent [if known], whichever is longer).
Immunotherapy within 4 weeks
Prior radionuclide therapy within 4 weeks

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

242

Study ID:

NCT03480646

Recruitment Status:

Active, not recruiting

Sponsor:

Constellation Pharmaceuticals

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There are 39 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

242

Study ID:

NCT03480646

Recruitment Status:

Active, not recruiting

Sponsor:


Constellation Pharmaceuticals

How clear is this clinincal trial information?

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