Breast Cancer Clinical Trial
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
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.
Full 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), a Follow-up Phase (every 3 months after end of treatment visit), and a Long-term Extension Phase (until participants no longer derive benefit from treatment or until further notification on different means of study treatment). Participants will be monitored for safety during the study period, and up to 30 days after the last dose of study drug.
Eligibility Criteria
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
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There is 1 Location for this study
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
Brussel , , Belgium
Charleroi , , Belgium
Gent , , Belgium
Haine-Saint-Paul, La Louviere , , Belgium
Hasselt , , Belgium
Kortrijk , , Belgium
Liège , , Belgium
Namur , , Belgium
Ottignies , , Belgium
Wilrijk , , Belgium
Barretos , , Brazil
Belo Horizonte , , Brazil
Curitiba , , Brazil
Fortaleza , , Brazil
Ijui , , Brazil
Itajai , , Brazil
Joinville , , Brazil
Natal , , Brazil
Salvador , , Brazil
Sao Paulo , , Brazil
Vancouver British Columbia, , Canada
Oshawa Ontario, , Canada
Toronto Ontario, , Canada
Montreal Quebec, , Canada
Quebec , , Canada
Aarhus N. , , Denmark
Copenhagen N , , Denmark
Herlev , , Denmark
Odense C , , Denmark
Avignon Cedex 9 , , France
Besancon , , France
Caen , , France
Lyon , , France
Nice Cedex 2 , , France
Paris , , France
Reims , , France
Strasbourg , , France
Villejuif Cedex , , France
Beer-Sheva , , Israel
Haifa , , Israel
Kfar Saba , , Israel
Ramat Gan , , Israel
Zrifin , , Israel
Seoul , , Korea, Republic of
Alkmaar , , Netherlands
Amsterdam , , Netherlands
Groningen , , Netherlands
Maastricht , , Netherlands
Rotterdam , , Netherlands
Moscow , , Russian Federation
Omsk , , Russian Federation
Tomsk , , Russian Federation
Barcelona , , Spain
Córdoba , , Spain
Madrid , , Spain
Málaga , , Spain
Pozuelo de Alarcon , , Spain
Santander , , Spain
Santiago de Compostela , , Spain
Sevilla , , Spain
Valencia , , Spain
Göteborg , , Sweden
Lund , , Sweden
Stockholm , , Sweden
Umeå , , Sweden
Kaohsiung , , Taiwan
Taichung , , Taiwan
Tainan , , Taiwan
Taipei , , Taiwan
Taoyuan County , , Taiwan
Blackburn , , United Kingdom
Bristol , , United Kingdom
Cardiff , , United Kingdom
Exeter , , United Kingdom
London , , United Kingdom
Preston , , United Kingdom
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