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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02854436
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : January 3, 2020
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Niraparib Phase 2

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), 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 301 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Actual Study Start Date : August 31, 2016
Estimated Primary Completion Date : February 21, 2020
Estimated Study Completion Date : June 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Niraparib
Participants will receive 300 milligram (mg) niraparib (3 capsules*100 mg) orally once daily.
Drug: Niraparib
Participants will receive 300 mg niraparib (3 capsules*100 mg) orally once daily.
Other Name: JNJ-64091742

Primary Outcome Measures :
  1. 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 ]
    ORR of soft tissue disease with no evidence of bone progression in participants with in Breast Cancer gene 1 (BRCA1) or gene 2 (BRCA2). ORR is defined as proportion of participants with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 4 years and 6 months ]
    ORR in participants with measurable metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies. ORR of soft tissue (visceral or nodal disease) as defined by RECIST 1.1 with no evidence of bone progression according to the Prostate Cancer Working Group 3 (PCWG3) criteria.

  2. Circulating Tumor Cells (CTC) Response [ Time Frame: From Screening till End of Treatment (30 {+/- 5} days of last dose -up to 4 years and 6 months) ]
    CTC response defined as CTC=0 per 7.5 milliliter (mL) blood at 8 weeks post-baseline in participants with baseline CTC greater than (>) 0.

  3. Overall Survival (OS) [ Time Frame: From enrollment to completion of study (up to 4 years and 6 months) ]
    OS is defined as time from enrollment to death from any cause.

  4. Radiographic Progression-Free Survival (rPFS) [ Time Frame: From enrollment to completion of study (up to 4 years and 6 months) ]
    rPFS is defined as time from enrollment to radiographic progression or death.

  5. Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From enrollment to completion of study (up to 4 years and 6 months) ]
    First PSA increase that is 25 percent (%) or greater and an absolute increase of 2 nanogram/milliliter (ng/mL) or more above the nadir.

  6. Time to Symptomatic Skeletal Event (SSE) [ Time Frame: From enrollment to completion of study (up to 4 years and 6 months) ]
    Time to SSE: time from enrollment to first symptomatic fracture, radiation or surgery to bone, or spinal cord compression.

  7. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From enrollment to completion of study (up to 4 years and 6 months) ]
  8. Duration of Objective Response [ Time Frame: From complete response (CR) or partial response (PR) to radiographic progression of disease (up to 4 years 6 months) ]
    Duration of objective response is defined as time from complete response or partial response to radiographic progression of disease, unequivocal clinical progression or death, whichever occurs first.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is 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 a second-generation or later 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 or non-metastatic castration-resistant prostate cancer with evidence of subsequent metastasis
  • Biomarker-positive by at least one of the following criteria: (a) Biallelic deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test (somatic local results must be confirmed as positive by the sponsor-validated assay before dosing)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02854436

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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:

Hide Hide 147 study locations
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United States, Arizona
Urological Associates of Southern Arizona, P.C. Recruiting
Tucson, Arizona, United States, 85741
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90089
Kaiser Permanente Recruiting
Riverside, California, United States, 92505
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
University Of California Withdrawn
San Francisco, California, United States, 94158
Stanford University School of Medicine Withdrawn
Stanford, California, United States, 94305
Cedars-Sinai Medical Center Withdrawn
West Hollywood, California, United States, 90048
United States, Colorado
University of Colorado Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
The Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
United States, Illinois
Northshore Universite Healthsystem Recruiting
Evanston, Illinois, United States, 60201
United States, Kentucky
Commonwealth Cancer Center Completed
Danville, Kentucky, United States, 40422
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Oncology & Hematology Specialists Withdrawn
Metairie, Louisiana, United States, 70006
Tulane University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
Chesapeake Urology Research Associates Withdrawn
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Massachusetts General Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, Nebraska
GU Research Network Not yet recruiting
Omaha, Nebraska, United States, 68130
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health & Science University Withdrawn
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lancaster Urology Recruiting
Lancaster, Pennsylvania, United States, 17601
Jefferson Medical Oncology Associates Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Atlantic Urology Clinics Recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Millennium Oncology Withdrawn
Houston, Texas, United States, 77090
United States, Utah
Intermountain Healthcare Not yet recruiting
Saint George, Utah, United States, 84770
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
INOVA Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
University of Washington School of Medicine Recruiting
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Chris O'Brien Lifehouse Recruiting
Camperdown, Australia, 2050
St. Vincent's Hospital Sydney Recruiting
Darlinghurst, Australia, 2010
Border Medical Oncology Recruiting
East Albury, Australia, 2640
Ashford Cancer Centre Recruiting
Kurralta Park, Australia, 5037
Peter MacCallum Cancer Centre Recruiting
Melbourne, Australia, 3000
Fiona Stanley Hospital Recruiting
Murdoch, Australia, 6150
Macquarie University Hospital Recruiting
North Ryde, Australia, 2109
Port Macquarie Base Hospital Recruiting
Port Macquarie, Australia, 2444
Prince Of Wales Hospital Recruiting
Randwick, Australia, 2031
Sydney Adventist Hospital Recruiting
Wahroonga, Australia, 2076
OLV Ziekenhuis Aalst Recruiting
Aalst, Belgium, 9300
Institut Jules Bordet Recruiting
Brussel, Belgium, 1000
Grand Hôpital de Charleroi, site Notre Dame Recruiting
Charleroi, Belgium, 6000
AZ Maria Middelares Recruiting
Gent, Belgium, 9000
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Jolimont Recruiting
Haine-Saint-Paul, La Louviere, Belgium, 7100
Virga Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
Az Groeninge Recruiting
Kortrijk, Belgium, 8500
Sart Tilman Recruiting
Liège, Belgium, 4000
Clinique et Maternité Sainte Elisabeth Recruiting
Namur, Belgium, 5000
Clinique St Pierre Recruiting
Ottignies, Belgium, 1340
GZA Ziekenhuizen- Campus St Augustinus Recruiting
Wilrijk, Belgium, 2610
Hospital Do Cancer De Barretos - Fundacao Pio Xii Recruiting
Barretos, Brazil, 14784-400
PERSONAL - Oncologia de Precisão e Personalizada Recruiting
Belo Horizonte, Brazil, 30130-090
Hospital Erasto Gaertner Recruiting
Curitiba, Brazil, 81520-060
Pronutrir Recruiting
Fortaleza, Brazil, 60 810180
Hospital de Caridade de Ijui Recruiting
Ijuí, Brazil, 98700-000
Clínica de Neoplasias Litoral Ltda. Recruiting
Itajai, Brazil, 88301-220
Instituto Joinvilense De Hematologia e Oncologia Recruiting
Joinville, Brazil, 89201260
Liga Norte Riograndense Contra O Cancer Recruiting
Natal, Brazil, 59075-740
Hospital Sao Rafael Recruiting
Salvador, Brazil, 41253-190
Instituto de Ensino E Pesquisa Sao Lucas Recruiting
Sao Paulo, Brazil, 01236-030
Hospital Israelita Albert Einstein Not yet recruiting
São Paulo, Brazil, 05651-900
Canada, Alberta
Prostate Cancer Centre Withdrawn
Calgary, Alberta, Canada, T2V 1P9
Canada, British Columbia
British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI) Withdrawn
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency (BCCA) - Vancouver Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1G1
Canada, Ontario
Lakeridge Health Oshawa Completed
Oshawa, Ontario, Canada
Sunnybrook Health Sciences Center Recruiting
Toronto, Ontario, Canada, M4N 3M5
University Health Network (UHN) Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre de Recherche du CHUM Recruiting
Montreal, Quebec, Canada, H2X 0A9
Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc Recruiting
Quebec, Canada, G1R2J6
Aarhus University Hospital Completed
Aarhus N., Denmark, 8200
Rigshospitalet Completed
Copenhagen, Denmark, 2100
Herlev Hospital Completed
Herlev, Denmark, 2730
Odense Universitetshospital Completed
Odense C, Denmark, 5000
Institut Sainte Catherine Recruiting
Avignon Cedex 9, France, 84918
CHRU De Besancon Recruiting
Besancon, France, 25030
Centre Francois Baclesse Recruiting
Caen, France, 14000
Centre Leon Bérard Recruiting
Lyon, France, 69008
Centre Antoine Lacassagne Recruiting
Nice Cedex 2, France, 06189
Hôpital Saint Louis Recruiting
Paris, France, 75010
Hopital Europeen Georges-Pompidou Withdrawn
Paris, France, 75015
Institut Jean Godinot Recruiting
Reims, France, 51100
Hôpitaux Universitaire de Strasbourg -CHU Recruiting
Strasbourg, France, 67091
Gustave Roussy Recruiting
Villejuif Cedex, France, 94805
Soroka Hospital Recruiting
Beer-Sheva, Israel, 85101
Rambam Hospital Recruiting
Haifa, Israel, 31096
Hadassah Medical Organization Ein Kerem Withdrawn
Jerusalem, Israel, 91120
Meir Hospital Recruiting
Kfar Saba, Israel, 44281
Sheba Medical Center Recruiting
Ramat Gan, Israel, 74047
Asaf Harofe Medical Center Recruiting
Zrifin, Israel, 60930
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 06273
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Mc Alkmaar Completed
Alkmaar, Netherlands, 1815 JD
VUMC Amsterdam Recruiting
Amsterdam, Netherlands, 1081 HV
Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9713 GZ
AZ Maastricht Recruiting
Maastricht, Netherlands, 6202
Radboudumc Withdrawn
Nijmegen, Netherlands, 6525 GA
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 GD
Russian Federation
FSBSI 'N. N. Blokhin Russian Cancer Research Center' Withdrawn
Moscow, Russian Federation, 115478
Russian Scientific Center of Roentgenoradiology Recruiting
Moscow, Russian Federation, 117997
Moscow City Clinical Hospital # 62 Withdrawn
Moscow, Russian Federation, 125130
Hertzen Oncology Research Institute Withdrawn
Moscow, Russian Federation, 125284
Privolzhsky District Medical Centre Withdrawn
Nizhny Novgorod, Russian Federation, 603001
Clinical Oncology Dispansary Recruiting
Omsk, Russian Federation, 644013
LLC Novaya Clinica Withdrawn
Pyatigorsk, Russian Federation, 357500
Leningrad Regional Oncology Dispensary Withdrawn
Saint-Petersburg, Russian Federation, 191104
Russian Scientific Center of Radiology and Surgical Technologies Withdrawn
St Petersburg, Russian Federation, 197758
Tomsk Cancer Research Institute Recruiting
Tomsk, Russian Federation, 634050
Hosp. de La Santa Creu I Sant Pau Recruiting
Barcelona, Spain, 08025
Hosp. Univ. Vall D´Hebron Recruiting
Barcelona, Spain, 08035
Hosp. Clinic I Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Hosp. Reina Sofia Recruiting
Córdoba, Spain, 14004
Hosp. Gral. Univ. Gregorio Marañon Recruiting
Madrid, Spain, 28007
Hosp. Clinico San Carlos Recruiting
Madrid, Spain, 28040
Hosp. Univ. Hm Sanchinarro Recruiting
Madrid, Spain, 28050
Hosp. Virgen de La Victoria Recruiting
Málaga, Spain, 29010
Hosp. Quiron Madrid Pozuelo Recruiting
Pozuelo de Alarcon, Spain, 28223
Hosp. Univ. Marques de Valdecilla Recruiting
Santander, Spain, 39008
Hosp. Clinico Univ. de Santiago Recruiting
Santiago de Compostela, Spain, 15706
Hosp. Virgen Del Rocio Recruiting
Sevilla, Spain, 41013
Hosp. Univ. I Politecni La Fe Recruiting
Valencia, Spain, 46026
Salgrenska University hospital Completed
Göteborg, Sweden, 413 45
Lund University Hospital/Skåne Recruiting
Lund, Sweden, 221 85
Karolinska Universitetssjukhuset Solna Recruiting
Stockholm, Sweden, 17176
Norrlands Universitetssjukhus Recruiting
Umeå, Sweden, 90185
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 88301
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70403
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 11490
Chang Gung Memorial Hospital Linkou Branch Recruiting
Taoyuan County, Taiwan, 333
United Kingdom
The Queen Elizabeth Hospital Withdrawn
Birmingham, United Kingdom, B15 2TH
Royal Blackburn Hospital Recruiting
Blackburn, United Kingdom, BB2 3HH
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Withdrawn
Bournemouth, United Kingdom, BH7 7DW
Bristol Haematology and Oncology Centre Recruiting
Bristol, United Kingdom, BS2 8ED
Velindre Hospital Recruiting
Cardiff, United Kingdom, CF14 2TL
Royal Devon & Exeter Hospital Recruiting
Exeter, United Kingdom, EX2 5DW
Royal Marsden Hospital Recruiting
London, United Kingdom, SW7 3RP
University College London Hospitals Recruiting
London, United Kingdom, WC1E 6BT
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital Recruiting
Preston, United Kingdom, PR2 9HT
Taunton and Somerset NHS Foundation Trust Withdrawn
Taunton, United Kingdom, TA1 5DA
Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC Identifier: NCT02854436    
Other Study ID Numbers: CR108208
64091742PCR2001 ( Other Identifier: Janssen Research & Development, LLC )
2016-002057-38 ( EudraCT Number )
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Prostate cancer
Metastatic castrate-resistant prostate cancer
Prostate neoplasm
DNA anomalies
DNA defect
PARP inhibitor
Additional relevant MeSH terms:
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Prostatic Neoplasms
Congenital Abnormalities
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents