Last updated on August 2019

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


Brief description of study

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 Study 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), 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.

Clinical Study Identifier: NCT02854436

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University of Southern California

Los Angeles, CA United States
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Kaiser Permanente

Riverside, CA United States
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University Of California

San Francisco, CA United States
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Cedars-Sinai Medical Center

West Hollywood, CA United States
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Commonwealth Cancer Center

Danville, KY United States
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Norton Healthcare

Louisville, KY United States
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Massachusetts General

Boston, MA United States
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Duke Cancer Institute

Durham, NC United States
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Lancaster Urology

Lancaster, PA United States
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Atlantic Urology Clinics

Myrtle Beach, SC United States
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MD Anderson Cancer Center

Houston, TX United States
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Millennium Oncology

Houston, TX United States
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University of Virginia

Charlottesville, VA United States
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INOVA

Fairfax, VA United States
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Ashford Cancer Centre

Kurralta Park, Australia
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Jolimont

Haine-Saint-Paul, La Louviere, Belgium
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Az Groeninge

Kortrijk, Belgium
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Sart Tilman

Liège, Belgium
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Pronutrir

Fortaleza, Brazil
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Rigshospitalet

Copenhagen, Denmark
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Gustave Roussy

Villejuif Cedex, France
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Soroka Hospital

Beer-Sheva, Israel
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Meir Hospital

Kfar Saba, Israel
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Severance Hospital

Seoul, Korea, Republic of
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Asan Medical Center

Seoul, Korea, Republic of
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Gangnam Severance Hospital

Seoul, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Mc Alkmaar

Alkmaar, Netherlands
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VUMC Amsterdam

Amsterdam, Netherlands
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AZ Maastricht

Maastricht, Netherlands
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Radboudumc

Nijmegen, Netherlands
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Erasmus MC

Rotterdam, Netherlands
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Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcon, Spain
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Hosp. Clinico Univ. de Santiago

Santiago de Compostela, Spain
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The Queen Elizabeth Hospital

Birmingham, United Kingdom
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Royal Blackburn Hospital

Blackburn, United Kingdom
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Velindre Hospital

Cardiff, United Kingdom
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Royal Marsden Hospital

London, United Kingdom
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Sart Tilman

Liège, Belgium
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Sart Tilman

Liège, Belgium
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Sart Tilman

Liège, Belgium
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Intermountain Healthcare

Saint George, UT United States
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Sart Tilman

Liège, Belgium
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Sart Tilman

Liège, Belgium
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Sart Tilman

Liège, Belgium
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Sart Tilman

Liège, Belgium
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Hosp. Clinico Univ. de Santiago

Santiago De Compostela, Spain
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Hosp. Quiron Madrid Pozuelo

Pozuelo De Alarcon, Spain
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