Clinical Research Details

Clinical Research

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

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.

 

Eligibility:

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: Brandi Calderon
Contact Phone: (904) 244-7413
Contact Email: brandi.calderon@jax.ufl.edu

Investigators


Principal Investigator
K.C. Balaji, M.B.B.S. (M.D.), FRCS, MRCS, LRCP
Urology

Sub Investigator
Mark Bandyk, M.D., M.P.H., M.S.
Urology