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Active Not Recruiting
NCT03431350
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Conditions: Prostatic Neoplasms, Castration-Resistant
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 136
Sponsor: Janssen Research & Development, LLC
Location: Urological Associates of Southern Arizona, P.C. Tucson Arizona
Summary
The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).
Eligibility Criteria
Inclusion Criteria for Combination 3:
* Diagnosed with mCRPC, who in the opinion of the investigator may benefit from treatment in Combination 3 of this study
* Able to continue gonadotropin releasing hormone analogue (GnRHa) therapy during the study if not surgically castrate (that is, subjects who has not undergone bilateral orchiectomy).
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (\
Source: ClinicalTrials.gov (NCT03431350). StuddyBuddy aggregates publicly available trial information.
