Spots Global Cancer Trial Database for An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
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Trial Identification
Brief Title: An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and 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
Study ID: NCT02854436
Conditions
Interventions
Study Description
Brief 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.
Detailed 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), a Follow-up Phase (every 3 months after end of treatment visit), and a Long-term Extension Phase (until participants no longer derive benefit from treatment or until further notification on different means of study treatment). Participants will be monitored for safety during the study period, and up to 30 days after the last dose of study drug.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
, Tucson, Arizona, United States
, Los Angeles, California, United States
, Riverside, California, United States
, Sacramento, California, United States
, Aurora, Colorado, United States
, Denver, Colorado, United States
, Evanston, Illinois, United States
, Danville, Kentucky, United States
, Louisville, Kentucky, United States
, New Orleans, Louisiana, United States
, Boston, Massachusetts, United States
, Detroit, Michigan, United States
, Omaha, Nebraska, United States
, New York, New York, United States
, Durham, North Carolina, United States
, Lancaster, Pennsylvania, United States
, Philadelphia, Pennsylvania, United States
, Myrtle Beach, South Carolina, United States
, Houston, Texas, United States
, Charlottesville, Virginia, United States
, Fairfax, Virginia, United States
, Seattle, Washington, United States
, Madison, Wisconsin, United States
, Camperdown, , Australia
, Darlinghurst, , Australia
, East Albury, , Australia
, Kurralta Park, , Australia
, Macquarie University, , Australia
, Melbourne, , Australia
, Murdoch, , Australia
, Port Macquarie, , Australia
, Randwick, , Australia
, Wahroonga, , Australia
, Aalst, , Belgium
, Brussel, , Belgium
, Charleroi, , Belgium
, Gent, , Belgium
, Haine-Saint-Paul, La Louviere, , Belgium
, Hasselt, , Belgium
, Kortrijk, , Belgium
, Liège, , Belgium
, Namur, , Belgium
, Ottignies, , Belgium
, Wilrijk, , Belgium
, Barretos, , Brazil
, Belo Horizonte, , Brazil
, Curitiba, , Brazil
, Fortaleza, , Brazil
, Ijui, , Brazil
, Itajai, , Brazil
, Joinville, , Brazil
, Natal, , Brazil
, Salvador, , Brazil
, Sao Paulo, , Brazil
, Vancouver, British Columbia, Canada
, Oshawa, Ontario, Canada
, Toronto, Ontario, Canada
, Montreal, Quebec, Canada
, Quebec, , Canada
, Aarhus N., , Denmark
, Copenhagen N, , Denmark
, Herlev, , Denmark
, Odense C, , Denmark
, Avignon Cedex 9, , France
, Besancon, , France
, Caen, , France
, Lyon, , France
, Nice Cedex 2, , France
, Paris, , France
, Reims, , France
, Strasbourg, , France
, Villejuif Cedex, , France
, Beer-Sheva, , Israel
, Haifa, , Israel
, Kfar Saba, , Israel
, Ramat Gan, , Israel
, Zrifin, , Israel
, Seoul, , Korea, Republic of
, Alkmaar, , Netherlands
, Amsterdam, , Netherlands
, Groningen, , Netherlands
, Maastricht, , Netherlands
, Rotterdam, , Netherlands
, Moscow, , Russian Federation
, Omsk, , Russian Federation
, Tomsk, , Russian Federation
, Barcelona, , Spain
, Córdoba, , Spain
, Madrid, , Spain
, Málaga, , Spain
, Pozuelo de Alarcon, , Spain
, Santander, , Spain
, Santiago de Compostela, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Göteborg, , Sweden
, Lund, , Sweden
, Stockholm, , Sweden
, Umeå, , Sweden
, Kaohsiung, , Taiwan
, Taichung, , Taiwan
, Tainan, , Taiwan
, Taipei, , Taiwan
, Taoyuan County, , Taiwan
, Blackburn, , United Kingdom
, Bristol, , United Kingdom
, Cardiff, , United Kingdom
, Exeter, , United Kingdom
, London, , United Kingdom
, Preston, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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