A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Description
Brief Summary
The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of
niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and
deoxyribonucleic acid (DNA) repair anomalies.
Detailed Description
This is a multicenter and open-label (participants and researchers are aware of the treatment
that participants are receiving) study that consists of 4 phases: a Prescreening Phase for
biomarker evaluation only, a Screening Phase, a Treatment Phase (Cycle 1 Day 1 and will
continue until the study drug is discontinued), a Follow-up Phase (every 3 months after end
of treatment visit), and a Long-term Extension Phase (until participants no longer derive
benefit from treatment or until further notification on different means of study treatment).
Participants will be monitored for safety during the study period, and up to 30 days after
the last dose of study drug.
Phase
N/AInclusion and Exclusion Criteria
- Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is excluded)
- Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer with evidence of disease progression on or after treatment, or discontinued from a taxane-based chemotherapy due to an adverse event
- Received a second-generation or later androgen receptor (AR)-targeted therapy (for example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the treatment of metastatic prostate cancer with evidence of disease progression or non-metastatic castration-resistant prostate cancer with evidence of subsequent metastasis
- Biomarker-positive by at least one of the following criteria: (a) Biallelic deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test (somatic local results must be confirmed as positive by the sponsor-validated assay before dosing)
- Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry
- Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor
- Prior platinum-based chemotherapy for the treatment of prostate cancer
- Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
- Symptomatic or impending cord compression
- Symptomatic brain metastases
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.