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8110 Gatehouse Road, Falls Church, VA 22042

An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies (Galahad)

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT02854436

Background Information

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.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • 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 settingBiomarker-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
  • Additional eligibility information in protocol

Ineligibility Information

  • 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)
  • Additional exclusions in protocol

Additional information can be found at https://clinicaltrials.gov/ct2/show/study/NCT02854436