UW CarbonePrint Friendly Page
Protocol No.
UW16140
Principal Investigator
Emamekhoo, Hamid
Phase
II
Age Group
Adult
Scope
National
Sponsor Type
Industry
Title
A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Objective
The main purpose of this study is to see if niraparib is useful to treat men with advanced prostate cancer. The safety of niraparib will also be studied.
Niraparib was approved for the treatment of ovarian cancer on March 27, 2017 in the United States. It is not approved for use by any regulatory authority in any country or for any other medical condition at this time. Therefore, other than for the treatment of ovarian cancer, niraparib can only be used in a research study such as this one.
The main purpose of this study is to see if niraparib is useful to treat men with advanced prostate cancer. The safety of niraparib will also be studied.
Niraparib was approved for the treatment of ovarian cancer on March 27, 2017 in the United States. It is not approved for use by any regulatory authority in any country or for any other medical condition at this time. Therefore, other than for the treatment of ovarian cancer, niraparib can only be used in a research study such as this one.
Treatment
Niraparib 300 mg orally once daily in the morning(with or without food) every 28 days
Description
Phase 2 study using Niraparib in Men with Metastatic Castration Resistant Prostate Cancer and DNA-Repair Anomalies
Key Eligibility
Must be willing to provide a tumor tissue sample (archival or recently collected), if feasible, and a blood sample for analysis of DNA-repair anomalies.
Must have documented evidence of disease progression while on second line of treatment for mCRPC.
Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is be excluded).
Must have had at least 1 line of taxane-based chemotherapy for the treatment of prostate cancer and at least 1 line of AR-targeted therapy (e.g., abiraterone acetate plus prednisone, enzalutamide, apalutamide) with documented evidence of disease progression while on therapy or within 3 months after discontinuation of therapy in the castrate-resistant setting
Must have testosterone less than or equal to 50 ng/dL on a LHRH or history of bilateral orchiectomy.
Must be able to continue GnRHa during the course of the study if not surgically castrate.
ECOG performance status less than or equal to 2.
Must be able to swallow pills.
Must agree to use medically accepted and highly effective methods of contraception during the course of the study and for 3 months after the last dose of study drug.
Adequate bone marrow, renal and liver function.
No prior treatment with PARP inhibitor
No prior platinum-based chemotherapy for the treatment of prostate cancer.
No known symptomatic or impending cord compression, except if subject has received definitive treatment for this and demonstrates evidence of clinically stable disease
No known symptomatic uncontrolled brain or leptomeningeal metastases (controlled isdefined as CNS disease which has undergone treatment [eg, radiation or surgery] at least 15 days prior to start of treatment
No prior history of clinically significant ventricular arrhythmias (eg, ventricular tachycardia,ventricular fibrillation, torsades de pointes).
Applicable Disease Sites
Prostate
Status
Open
Participating Institutions
UW Hospital and Clinics
