Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
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)
  • At least 1 line of taxane-based chemotherapy for the treatment of prostate cancer with documented evidence of disease progression while on therapy or within 3 months after discontinuation of therapy in the castrate-resistant setting
  • At least 1 line of androgen receptor (AR)-targeted therapy (for example {e.g.},abiraterone acetate plus prednisone, enzalutamide, apalutamide) for prostate cancer with documented evidence of disease progression while on therapy or within 3 months after discontinuation of therapy in the castrate-resistant setting
  • 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)
  • Known symptomatic or impending cord compression
  • Known symptomatic uncontrolled brain or leptomeningeal metastases (Day 1)

Locations

  • University Of California not yet accepting patients
    San Francisco, California, 94158, United States
  • Stanford University School of Medicine withdrawn
    Stanford, California, 94305, United States
  • UC Davis Comprehensive Cancer Center currently not accepting new patients, but might later
    Sacramento, California, 95817, United States
  • Cedars-Sinai Medical Center withdrawn
    West Hollywood, California, 90048, United States
  • University of Southern California not yet accepting patients
    Los Angeles, California, 90089, United States
  • Kaiser Permanente not yet accepting patients
    Riverside, California, 92505, 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
Lead Scientist
Won Kim
Study Type
Interventional
Last Updated
April 26, 2018