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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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: 1. First generation: AR antagonists (e.g., bicalutamide, nilutamide, flutamide) within 4 weeks 2. 5 alpha reductase inhibitors, ketoconazole, estrogens (including diethylstilbesterol [DES]), or progesterones within 2 weeks 3. Chemotherapy within 3 weeks 4. Biologic therapy within 4 weeks 5. 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). 6. Immunotherapy within 4 weeks 7. Prior radionuclide therapy within 4 weeks

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CPI-1205 Combination with Enzalutamide
  • Drug: CPI-1205
    Administered orally
  • Drug: Enzalutamide
    Administered orally
Experimental
CPI-1205 Combination with Abiraterone/Prednisone
  • Drug: CPI-1205
    Administered orally
  • Drug: Abiraterone/Prednisone
    Administered orally

More Details

Status
Unknown status
Sponsor
Constellation Pharmaceuticals

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.