Clinical Research Details

A Phase 1b/2 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, Combined with Enzalutamide or Abiraterone/Prednisone in Patients with Metastatic Castration

Study Description

The purpose of this study is to see if the drug, CPI-1205, in combination with standard of care treatments enzalutamide or abiraterone/prednisone can improve conditions for males with metastatic castration resistant prostate cancer. The study is designed to determine the best dose for CPI-1205.

Inclusion/Exclusion Criteria

Inclusion Criteria:

  • Adults (Age ≥ 18 years)
  • Metastatic prostate cancer
  • Must have undergone surgical or medical castration
  • Progressive disease in the setting of medical or surgical castration (i.e. CRPC) as defined by elevated PSA AND/OR progression based on bone scan or CT scan
  • Serum testosterone <50 ng/dL
  • Prior hormonal treatment for metastatic disease
  • Demonstrate adequate organ function

Exclusion Criteria:

  • Known symptomatic brain metastases
  • Clinically significant cardiovascular disease
  • Active viral hepatitis or chronic liver disease
  • GI disorder that negatively affects absorption
  • Any other ongoing severe and/or uncontrolled medical condition

Open Enrollment

Contact Name: Guerline St. Louis
Contact Phone: (904) 244-7413
Contact Email: guerline.stlouis@jax.ufl.edu

Investigators