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 Resistant Prostate Cancer
R
Roberto Pili, MD
Primary Investigator
Overview
This study is designed to determine the maximum tolerated dose (MTD) of CPI-1205 in combination with either enzalutamide or abiraterone/prednisone in male patients with Metastatic Castration Resistant Prostate Cancer.
Description
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of CPI-1205 + enzalutamide and CPI-1205 + abiraterone/prednisone in patients with metastatic castration resistant prostate cancer (mCRPC).
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Metastatic Castration Resistant Prostate Cancer,Metastatic Castration Resistant Prostate Cancer
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Age: Between 18 Years - 100 Years
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Gender: Male
Inclusion Criteria
Histologically or cytologically confirmed adenocarcinoma of the prostate (prostate cancer)
Progressive disease in the setting of medical or surgical castration (i.e., CRPC)
Documented metastatic disease (may be measurable or non-measurable)
Must have undergone bilateral orchiectomy (surgical castration) or be willing to continue gonadotropin-releasing hormone (GnRH) analog or antagonist (medical castration)
Exclusion Criteria
Known symptomatic brain metastases (NOTE: patients with treated epidural disease are allowed)
Participants will not be paid for their participation.
Updated on
20 Apr 2024.
Study ID: 1712520224 (1205-201)
