Summary

for males ages 18 years and up (full criteria)
at UC Davis UCSF
study started
estimated completion

Description

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.

Official Title

A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Details

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), and a Follow-up Phase (every 3 months after end of treatment visit). Participants will be monitored for safety during the study period, and up to 30 days after the last dose of study drug.

Keywords

Prostatic Neoplasms Prostate cancer CRPC Metastatic castrate-resistant prostate cancer Prostate neoplasm Galahad Niraparib DNA anomalies DNA defect PARP inhibitor PARPi Congenital Abnormalities

Eligibility

You can join if…

Open to males ages 18 years and up

  • Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is be 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 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
  • Biomarker-positive for deoxyribonucleic acid (DNA)-repair anomalies
  • Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry

You CAN'T join if...

  • 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

Locations

  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • University Of California withdrawn
    San Francisco California 94158 United States
  • Cedars-Sinai Medical Center withdrawn
    West Hollywood California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
To learn how to participate in this trial please click here.
ID
NCT02854436
Phase
Phase 2
Study Type
Interventional
Last Updated