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A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).
Official title: A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2018-03-02
Completion Date
2026-12-31
Last Updated
2026-03-25
Healthy Volunteers
No
Interventions
Niraparib 200 mg
Participants will receive niraparib 200 mg orally.
Cetrelimab 240 mg
Participants will receive cetrelimab 240 mg IV every 2 weeks.
Cetrelimab 480 mg
Participants will receive cetrelimab 480 mg IV every 4 weeks.
Abiraterone acetate 1000 mg
Participants will receive AA 1000 mg orally.
Prednisone 5 mg
Participants will receive prednisone 5 mg orally.
Locations (50)
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States
The Urology Center of Colorado
Denver, Colorado, United States
Mayo Clinic - Division Of Hematology/oncology
Jacksonville, Florida, United States
First Urology, PSC
Jeffersonville, Indiana, United States
Chesapeake Urology Research Associates
Towson, Maryland, United States
Michigan Institute of Urology
Troy, Michigan, United States
New York Oncology Hematology
Albany, New York, United States
Memorial Sloan Kettering Cancer Center
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
MUSC-Hollings Cancer Center
Charleston, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates
Nashville, Tennessee, United States
Houston Metro Urology
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Urology of Virginia, PLCC
Virginia Beach, Virginia, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
OLV Ziekenhuis Aalst
Aalst, Belgium
ZNA Middelheim
Antwerp, Belgium
ULB Hôpital Erasme
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Az Groeninge
Kortrijk, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, Belgium
Southern Alberta Institute of Urology / Prostate Cancer Centre
Calgary, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
Centre de Recherche du CHUM
Montreal, Quebec, Canada
Asaf Harofe Medical Center
Beer Yaakov, Israel
Soroka Hospital
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center Tel Hashomer
Ramat Gan, Israel
Azienda Ospedaliera Universitaria Careggi di Firenze
Florence, Italy
Azienda Ospedaliera ''Vito Fazzi''
Lecce, Italy
UOC Oncologia Ospedale Provinciale di Macerata
Macerata, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
IRCCS-Fondazione Pascale
Naples, Italy
Hosp. de La Santa Creu I Sant Pau
Barcelona, Spain
Hospital Vall D'Hebron
Barcelona, Spain
Hosp. Univ. de La Princesa
Madrid, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Hosp Univ Hm Sanchinarro
Madrid, Spain
Hosp Virgen de La Victoria
Málaga, Spain
Royal United Hospital
Bath, United Kingdom
University College London Hospitals
London, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
The Royal Marsden NHS Trust Sutton
Sutton, United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Truro, United Kingdom