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Trial Summary

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

Acronym:

GALAHAD

ACTRN/NCT /ethics:

NCT02854436

Scientific title:

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

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

Sponsor / Cooperative group:

Janssen Research & Development LLC

Trial & Patient Characteristics

Cancer TypeProstate
Trial TypeTreatment
PhasePhase II
Age Range18+ years
SexBoth
Tumour StreamProstate
Cancer StageLocally Recurrent or Locally Advanced
Anticipated Start Date2016-08-31
Anticipated End Date2019-10-10

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Francis Parnis
Recruitment StatusRecruiting