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.
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
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There are 39 Locations for this study
Anchorage Alaska, 99503, United States
Beverly Hills California, 90211, United States
Duarte California, 91010, United States
Los Angeles California, 90095, United States
Aurora Colorado, 80045, United States
Aurora Colorado, 80045, United States
Jacksonville Florida, 32209, United States
Miami Florida, 33140, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Indianapolis Indiana, 46202, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21205, United States
Rockville Maryland, 20850, United States
Boston Massachusetts, 02115, United States
Detroit Michigan, 48202, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89135, United States
Albuquerque New Mexico, 87106, United States
Bronx New York, 10469, United States
Buffalo New York, 14263, United States
East Setauket New York, 11733, United States
New York New York, 10016, United States
New York New York, 10029, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 22710, United States
Columbus Ohio, 43210, United States
Toledo Ohio, 43623, United States
Eugene Oregon, 97401, United States
Tualatin Oregon, 97062, United States
Bethlehem Pennsylvania, 18015, United States
Gettysburg Pennsylvania, 17331, United States
Greenville South Carolina, 29605, United States
Myrtle Beach South Carolina, 29572, United States
Austin Texas, 78731, United States
Fort Worth Texas, 76104, United States
Tyler Texas, 75702, United States
Hampton Virginia, 23666, United States
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