An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
NCT ID: NCT02854436
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
289 participants
INTERVENTIONAL
2016-08-31
2023-08-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Niraparib
Participants will receive 300 milligram (mg) niraparib (3 capsules\*100 mg) orally once daily.
Niraparib
Participants will receive 300 mg niraparib (3 capsules\*100 mg) orally once daily.
Interventions
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Niraparib
Participants will receive 300 mg niraparib (3 capsules\*100 mg) orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
Brussels, , Belgium
Charleroi, , Belgium
Ghent, , Belgium
Haine-Saint-Paul, , Belgium
Hasselt, , Belgium
Kortrijk, , Belgium
Liège, , Belgium
Namur, , Belgium
Ottignies, , Belgium
Wilrijk, , Belgium
Barretos, , Brazil
Belo Horizonte, , Brazil
Curitiba, , Brazil
Fortaleza, , Brazil
Ijuí, , Brazil
Itajaí, , Brazil
Joinville, , Brazil
Natal, , Brazil
Salvador, , Brazil
São Paulo, , Brazil
Vancouver, British Columbia, Canada
Oshawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Aarhus N, , Denmark
Copenhagen N, , Denmark
Herlev, , Denmark
Odense C, , Denmark
Avignon, , France
Besançon, , France
Caen, , France
Lyon, , France
Nice, , France
Paris, , France
Reims, , France
Strasbourg, , France
Villejuif, , France
Beersheba, , Israel
Haifa, , Israel
Kfar Saba, , Israel
Ramat Gan, , Israel
Zrifin, , Israel
Alkmaar, , Netherlands
Amsterdam, , Netherlands
Groningen, , Netherlands
Maastricht, , Netherlands
Rotterdam, , Netherlands
Moscow, , Russia
Omsk, , Russia
Tomsk, , Russia
Seoul, , South Korea
Barcelona, , Spain
Córdoba, , Spain
Madrid, , Spain
Málaga, , Spain
Pozuelo de Alarcón, , Spain
Santander, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Lund, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Blackburn, , United Kingdom
Bristol, , United Kingdom
Cardiff, , United Kingdom
Exeter, , United Kingdom
London, , United Kingdom
Preston, , United Kingdom
Countries
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References
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Smith MR, Sandhu S, George DJ, Chi KN, Saad F, Thiery-Vuillemin A, Stahl O, Olmos D, Danila DC, Gafanov R, Castro E, Moon H, Joshua AM, Mason GE, Espina BM, Liu Y, Lopez-Gitlitz A, Francis P, Bevans KB, Fizazi K. Health-related quality of life in GALAHAD: A multicenter, open-label, phase 2 study of niraparib for patients with metastatic castration-resistant prostate cancer and DNA-repair gene defects. J Manag Care Spec Pharm. 2023 Jul;29(7):758-768. doi: 10.18553/jmcp.2023.29.7.758.
Smith MR, Scher HI, Sandhu S, Efstathiou E, Lara PN Jr, Yu EY, George DJ, Chi KN, Saad F, Stahl O, Olmos D, Danila DC, Mason GE, Espina BM, Zhao X, Urtishak KA, Francis P, Lopez-Gitlitz A, Fizazi K; GALAHAD investigators. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):362-373. doi: 10.1016/S1470-2045(21)00757-9. Epub 2022 Feb 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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64091742PCR2001
Identifier Type: OTHER
Identifier Source: secondary_id
2016-002057-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108208
Identifier Type: -
Identifier Source: org_study_id