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



Status:Recruiting
Conditions:Prostate Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:August 31, 2016
End Date:February 28, 2020
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:
Email:JNJ.CT@sylogent.com

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

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.

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.

Inclusion Criteria:

- Histologically confirmed prostate cancer (mixed histology is acceptable, with the
exception of the small cell pure phenotype, which is be excluded)

- Received at least 1 line of taxane-based chemotherapy for the treatment of metastatic
castration-resistant prostate cancer (mCRPC) with documented evidence of disease
progression prior to enrollment

- Received at least 1 line of androgen receptor (AR)-targeted therapy (for example
{e.g.}, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for treatment
of mCRPC with documented evidence of disease progression prior to enrollment

- 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
We found this trial at
30
sites
4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Baltimore, Maryland 21204
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Boston, Massachusetts 02114
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119-143 Missenden Road
Camperdown, 2050
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Danville, Kentucky 40422
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Denver, Colorado 80211
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20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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1301 Central Street
Evanston, Illinois 60201
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8505 Arlington Boulevard
Fairfax, Virginia 22031
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Houston, Texas 77030
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Houston, Texas 77090
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Lancaster, Pennsylvania 17604
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Louisville, Kentucky 40207
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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Metairie, Louisiana 70006
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Myrtle Beach, South Carolina 29572
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New Orleans, Louisiana 70112
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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833 Chestnut Street
Philadelphia, Pennsylvania 19107
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Riverside, California 92505
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4501 X St
Sacramento, California 95817
(916) 734-5800
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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San Francisco, California 94143
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West Hollywood, California 90048
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