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Treatment Study for Patients with Metastatic Castration Resistant Prostate Cancer
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.
In order to participate you must meet the following criteria:
- Have a life expectancy of at least 12 weeks.
- Have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Have progressive disease in the setting of medical or surgical castration (i.e. CRPC).
- Have documented metastatic disease.
You will be excluded from the study if any of the following criteria apply to you:
- Have known symptomatic brain metastases.
This is a partial list of inclusion and exclusion criteria.