A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

March 2, 2018

Primary Completion Date

August 31, 2021

Study Completion Date

December 31, 2025

Conditions
Prostatic Neoplasms, Castration-Resistant
Interventions
DRUG

Niraparib 200 mg

Participants will receive niraparib 200 mg orally.

DRUG

Cetrelimab 240 mg

Participants will receive cetrelimab 240 mg IV every 2 weeks.

DRUG

Cetrelimab 480 mg

Participants will receive cetrelimab 480 mg IV every 4 weeks.

DRUG

Abiraterone acetate 1000 mg

Participants will receive AA 1000 mg orally.

DRUG

Prednisone 5 mg

Participants will receive prednisone 5 mg orally.

Trial Locations (50)

1070

ULB Hôpital Erasme, Brussels

2020

ZNA Middelheim, Antwerp

8035

Hospital Vall D'Hebron, Barcelona

8500

Az Groeninge, Kortrijk

9000

Universitair Ziekenhuis Gent, Ghent

9300

OLV Ziekenhuis Aalst, Aalst

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Cancer Center, Harrison

12208

New York Oncology Hematology, Albany

15232

University of Pittsburgh Medical Center (UPMC), Pittsburgh

19107

Thomas Jefferson University, Philadelphia

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

21204

Chesapeake Urology Research Associates, Towson

23462

Urology of Virginia, PLCC, Virginia Beach

28006

Hosp. Univ. de La Princesa, Madrid

28040

Hosp Univ Fund Jimenez Diaz, Madrid

28050

Hosp Univ Hm Sanchinarro, Madrid

29010

Hosp Virgen de La Victoria, Málaga

29425

MUSC-Hollings Cancer Center, Charleston

29572

Carolina Urologic Research Center, Myrtle Beach

31096

Rambam Medical Center, Haifa

32224

Mayo Clinic - Division Of Hematology/oncology, Jacksonville

37209

Urology Associates, Nashville

47130

First Urology, PSC, Jeffersonville

48084

Michigan Institute of Urology, Troy

49100

Rabin Medical Center, Petah Tikva

50134

Azienda Ospedaliera Universitaria Careggi di Firenze, Florence

52621

Sheba Medical Center Tel Hashomer, Ramat Gan

60930

Asaf Harofe Medical Center, Beer Yaakov

62100

UOC Oncologia Ospedale Provinciale di Macerata, Macerata

73100

Azienda Ospedaliera ''Vito Fazzi'', Lecce

77027

Houston Metro Urology, Houston

77030

The University of Texas MD Anderson Cancer Center, Houston

80131

IRCCS-Fondazione Pascale, Napoli

80211

The Urology Center of Colorado, Denver

84106

Utah Cancer Specialists, Salt Lake City

85101

Soroka Hospital, Beersheba

85741

Urological Associates of Southern Arizona, P.C., Tucson

5379200

University of Wisconsin Carbone Cancer Center, Madison

B-4000

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman, Liège

T2V 1P9

Southern Alberta Institute of Urology / Prostate Cancer Centre, Calgary

V5Z4E6

British Columbia Cancer Agency, Vancouver

M5G2M9

Princess Margaret Cancer Centre University Health Network, Toronto

H2X 0A9

Centre de Recherche du CHUM, Montreal

08025

Hosp. de La Santa Creu I Sant Pau, Barcelona

BA1 3NG

Royal United Hospital, Bath

WC1E 6BT

University College London Hospitals, London

SO16 6YD

Southampton General Hospital, Southampton

SM2 5PT

The Royal Marsden NHS Trust Sutton, Sutton

TR1 3LJ

Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital, Truro

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03431350 - A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer | Biotech Hunter | Biotech Hunter