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

Status: Active

Description

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

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Ankush Sachdeva
Phone: 310-794-3421
Email: asachdeva@mednet.ucla.edu

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Florida

Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Michele Ann Besche
Phone: 410-328-8610
Email: mbesche@umm.edu

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Approved
Name Not Available
Durham
Duke University Medical Center
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Constellation Pharmaceuticals

Trial IDs

Primary ID 1205-201
Secondary IDs NCI-2018-00828
Clinicaltrials.gov ID NCT03480646