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


Condition: Prostatic Neoplasms

Intervention:

  • Drug: Niraparib

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02854436

Sponsor: Janssen Research & Development, LLC

Primary Outcome Measures:

  • Measure: Objective Response Rate (ORR)
  • Time Frame: Screening, Cycle 1 (each cycle of 28 days) Day 1 (every 8 weeks for the first 6 months and then every 12 weeks thereafter) till Follow-up Phase
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Objective Response Rate (ORR)
  • Time Frame: Approximately up to 3 years and 2 months
  • Safety Issue:
  • Measure: Circulating Tumor Cells (CTC) Response
  • Time Frame: From Screening till End of Treatment (30 {+/- 5} days of last dose - approximately up to 3 years and 2 months)
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months)
  • Safety Issue:
  • Measure: Radiographic Progression-Free Survival (rPFS)
  • Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months)
  • Safety Issue:
  • Measure: Time to Prostate Specific Antigen (PSA) Progression
  • Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months)
  • Safety Issue:
  • Measure: Time to Symptomatic Skeletal Event (SSE)
  • Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months)
  • Safety Issue:
  • Measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
  • Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months)
  • Safety Issue:
  • Measure: Duration of Objective Response
  • Time Frame: From complete response (CR) or partial response (PR) to radiographic progression of disease (approximately up to 3 years and 2 months)
  • Safety Issue:

Estimated Enrollment: 301

Study Start Date: August 31, 2016

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is be excluded)
  • Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer with evidence of disease progression on or after treatment, or discontinued from a taxane-based chemotherapy due to an adverse event
  • Received androgen receptor (AR)-targeted therapy (for example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the treatment of metastatic prostate cancer with evidence of disease progression
  • Biomarker-positive for deoxyribonucleic acid (DNA)-repair anomalies
  • Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry

Exclusion Criteria:

  • Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor
  • Prior platinum-based chemotherapy for the treatment of prostate cancer
  • Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
  • Symptomatic or impending cord compression
  • Symptomatic brain metastases

Contact:

  • Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

Locations:

  • Urological Associates of Southern Arizona, P.C.
  • Tucson Arizona 85741 United States
  • University of Southern California
  • Los Angeles California 90089 United States
  • Kaiser Permanente
  • Riverside California 92505 United States
  • UC Davis Comprehensive Cancer Center
  • Sacramento California 95817 United States
  • University Of California
  • San Francisco California 94158 United States
  • Stanford University School of Medicine
  • Stanford California 94305 United States
  • Cedars-Sinai Medical Center
  • West Hollywood California 90048 United States
  • University of Colorado Health Sciences Center
  • Aurora Colorado 80045 United States
  • The Urology Center of Colorado
  • Denver Colorado 80211 United States
  • Northshore Universite Healthsystem
  • Evanston Illinois 60201 United States
  • Commonwealth Cancer Center
  • Danville Kentucky 40422 United States
  • Norton Healthcare
  • Louisville Kentucky 40202 United States
  • Oncology & Hematology Specialists
  • Metairie Louisiana 70006 United States
  • Tulane University School of Medicine
  • New Orleans Louisiana 70112 United States
  • Chesapeake Urology Research Associates
  • Baltimore Maryland 21204 United States
  • Massachusetts General
  • Boston Massachusetts 02115 United States
  • Barbara Ann Karmanos Cancer Institute
  • Detroit Michigan 48201 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Duke Cancer Institute
  • Durham North Carolina 27710 United States
  • Oregon Health & Science University
  • Portland Oregon 97239 United States
  • Lancaster Urology
  • Lancaster Pennsylvania 17601 United States
  • Jefferson Medical Oncology Associates
  • Philadelphia Pennsylvania 19107 United States
  • Atlantic Urology Clinics
  • Myrtle Beach South Carolina 29572 United States
  • MD Anderson Cancer Center
  • Houston Texas 77030 United States
  • Millennium Oncology
  • Houston Texas 77090 United States
  • Intermountain Healthcare
  • Saint George Utah 84770 United States
  • University of Virginia
  • Charlottesville Virginia 22908 United States
  • INOVA
  • Fairfax Virginia 22031 United States
  • University of Washington School of Medicine
  • Seattle Washington 98195 United States
  • University of Wisconsin Carbone Cancer Center
  • Madison Wisconsin 53792 United States
  • Chris O'Brien Lifehouse
  • Camperdown 2050 Australia
  • St. Vincent's Hospital Sydney
  • Darlinghurst 2010 Australia
  • Border Medical Oncology
  • East Albury 2640 Australia
  • Ashford Cancer Centre
  • Kurralta Park 5037 Australia
  • Peter MacCallum Cancer Centre
  • Melbourne 3000 Australia
  • Fiona Stanley Hospital
  • Murdoch 6150 Australia
  • Macquarie University Hospital
  • North Ryde 2109 Australia
  • Port Macquarie Base Hospital
  • Port Macquarie 2444 Australia
  • Prince Of Wales Hospital
  • Randwick 2031 Australia
  • Sydney Adventist Hospital
  • Wahroonga 2076 Australia
  • OLV Ziekenhuis Aalst
  • Aalst 9300 Belgium
  • Institut Jules Bordet
  • Brussel 1000 Belgium
  • Grand Hôpital de Charleroi, site Notre Dame
  • Charleroi 6000 Belgium
  • AZ Maria Middelares
  • Gent 9000 Belgium
  • Universitair Ziekenhuis Gent
  • Gent 9000 Belgium
  • Jolimont
  • Haine-Saint-Paul, La Louviere 7100 Belgium
  • Virga Jessa Ziekenhuis
  • Hasselt 3500 Belgium
  • Az Groeninge
  • Kortrijk 8500 Belgium
  • Sart Tilman
  • Liège 4000 Belgium
  • Clinique et Maternité Sainte Elisabeth
  • Namur 5000 Belgium
  • Clinique St Pierre
  • Ottignies 1340 Belgium
  • GZA Ziekenhuizen- Campus St Augustinus
  • Wilrijk 2610 Belgium
  • Hospital Do Cancer De Barretos - Fundacao Pio Xii
  • Barretos 14784-400 Brazil
  • PERSONAL - Oncologia de Precisão e Personalizada
  • Belo Horizonte 30130-090 Brazil
  • Hospital Erasto Gaertner
  • Curitiba 81520-060 Brazil
  • Pronutrir
  • Fortaleza 60 810180 Brazil
  • Hospital de Caridade de Ijui
  • Ijuí 98700-000 Brazil
  • Clínica de Neoplasias Litoral Ltda.
  • Itajai 88301-220 Brazil
  • Instituto Joinvilense De Hematologia e Oncologia
  • Joinville 89201260 Brazil
  • Liga Norte Riograndense Contra O Cancer
  • Natal 59075-740 Brazil
  • Hospital Sao Rafael
  • Salvador 41253-190 Brazil
  • Instituto de Ensino E Pesquisa Sao Lucas
  • Sao Paulo 01236-030 Brazil
  • Hospital Israelita Albert Einstein
  • São Paulo 05651-900 Brazil
  • Prostate Cancer Centre
  • Calgary Alberta T2V 1P9 Canada
  • British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)
  • Kelowna British Columbia V1Y 5L3 Canada
  • British Columbia Cancer Agency (BCCA) - Vancouver Centre
  • Vancouver British Columbia V5Z 4E6 Canada
  • Lakeridge Health Oshawa
  • Oshawa Ontario Canada
  • Sunnybrook Health Sciences Center
  • Toronto Ontario M4N 3M5 Canada
  • University Health Network (UHN) Princess Margaret Cancer Centre
  • Toronto Ontario M5G 2M9 Canada
  • Centre de Recherche du CHUM
  • Montreal Quebec H2X 0A9 Canada
  • Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc
  • Quebec G1R2J6 Canada
  • Aalborg University Hospital
  • Aalborg 9000 Denmark
  • Aarhus University Hospital
  • Aarhus N. 8200 Denmark
  • Copenhagen University Hospital
  • Copenhagen 2100 Denmark
  • Rigshospitalet
  • Copenhagen 2100 Denmark
  • Gentofte Herlev Hospital
  • Herlev 2730 Denmark
  • Herlev Hospital
  • Herlev 2730 Denmark
  • Odense Universitetshospital
  • Odense C 5000 Denmark
  • Institut Sainte Catherine
  • Avignon Cedex 9 84918 France
  • CHRU De Besancon
  • Besancon 25030 France
  • Centre Francois Baclesse
  • Caen 14000 France
  • Centre Leon Bérard
  • Lyon 69008 France
  • Centre Antoine Lacassagne
  • Nice Cedex 2 06189 France
  • Hôpital Saint Louis
  • Paris 75010 France
  • Hopital Europeen Georges-Pompidou
  • Paris 75015 France
  • Institut Jean Godinot
  • Reims 51100 France
  • Hôpitaux Universitaire de Strasbourg -CHU
  • Strasbourg 67091 France
  • Gustave Roussy
  • Villejuif Cedex 94805 France
  • Soroka Hospital
  • Beer-Sheva 85101 Israel
  • Rambam Hospital
  • Haifa 31096 Israel
  • Hadassah Medical Organization Ein Kerem
  • Jerusalem 91120 Israel
  • Meir Hospital
  • Kfar Saba 44281 Israel
  • Sheba Medical Center
  • Ramat Gan 74047 Israel
  • Asaf Harofe Medical Center
  • Zrifin 60930 Israel
  • Severance Hospital
  • Seoul 03722 Korea, Republic of
  • Asan Medical Center
  • Seoul 05505 Korea, Republic of
  • Gangnam Severance Hospital
  • Seoul 06273 Korea, Republic of
  • Samsung Medical Center
  • Seoul 06351 Korea, Republic of
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul 06591 Korea, Republic of
  • Mc Alkmaar
  • Alkmaar 1815 JD Netherlands
  • VUMC Amsterdam
  • Amsterdam 1081 HV Netherlands
  • Universitair Medisch Centrum Groningen
  • Groningen 9713 GZ Netherlands
  • AZ Maastricht
  • Maastricht 6202 Netherlands
  • Radboudumc
  • Nijmegen 6525 GA Netherlands
  • Erasmus MC
  • Rotterdam 3015 GD Netherlands
  • Russian Scientific Center of Roentgenoradiology
  • Moscow 117997 Russian Federation
  • Moscow City Clinical Hospital # 62
  • Moscow 125130 Russian Federation
  • Hertzen Oncology Research Institute
  • Moscow 125284 Russian Federation
  • Clinical Oncology Dispansary
  • Omsk 644013 Russian Federation
  • Tomsk Cancer Research Institute
  • Tomsk 634050 Russian Federation
  • Hosp. de La Santa Creu I Sant Pau
  • Barcelona 08025 Spain
  • Hosp. Univ. Vall D Hebron
  • Barcelona 08035 Spain
  • Hosp. Clinic I Provincial de Barcelona
  • Barcelona 08036 Spain
  • Hosp. Reina Sofia
  • Córdoba 14004 Spain
  • Hosp. Gral. Univ. Gregorio Maranon
  • Madrid 28007 Spain
  • Hosp. Clinico San Carlos
  • Madrid 28040 Spain
  • Hosp. Univ. Hm Sanchinarro
  • Madrid 28050 Spain
  • Hosp. Virgen de La Victoria
  • Málaga 29010 Spain
  • Hosp. Quiron Madrid Pozuelo
  • Pozuelo de Alarcon 28223 Spain
  • Hosp. Univ. Marques de Valdecilla
  • Santander 39008 Spain
  • Hosp. Clinico Univ. de Santiago
  • Santiago de Compostela 15706 Spain
  • Hosp. Virgen Del Rocio
  • Sevilla 41013 Spain
  • Hosp. Univ. I Politecni La Fe
  • Valencia 46026 Spain
  • Salgrenska University hospital
  • Göteborg 413 45 Sweden
  • Lund University Hospital/Skåne
  • Lund 221 85 Sweden
  • Karolinska Universitetssjukhuset Solna
  • Stockholm 17176 Sweden
  • Norrlands Universitetssjukhus
  • Umeå 90185 Sweden
  • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung 88301 Taiwan
  • China Medical University Hospital
  • Taichung 40447 Taiwan
  • Taichung Veterans General Hospital
  • Taichung 40705 Taiwan
  • National Cheng Kung University Hospital
  • Tainan 70403 Taiwan
  • National Taiwan University Hospital
  • Taipei 10002 Taiwan
  • Tri-Service General Hospital
  • Taipei 11490 Taiwan
  • Chang Gung Memorial Hospital Linkou Branch
  • Taoyuan County 333 Taiwan
  • The Queen Elizabeth Hospital
  • Birmingham B15 2TH United Kingdom
  • Royal Blackburn Hospital
  • Blackburn BB2 3HH United Kingdom
  • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
  • Bournemouth BH7 7DW United Kingdom
  • Bristol Haematology and Oncology Centre
  • Bristol BS2 8ED United Kingdom
  • Velindre Hospital
  • Cardiff CF14 2TL United Kingdom
  • Royal Devon & Exeter Hospital
  • Exeter EX2 5DW United Kingdom
  • Royal Marsden Hospital
  • London SW7 3RP United Kingdom
  • University College London Hospitals
  • London WC1E 6BT United Kingdom
  • Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
  • Preston PR2 9HT United Kingdom
  • Taunton and Somerset NHS Foundation Trust
  • Taunton TA1 5DA United Kingdom

View trial on ClinicalTrials.gov


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