A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:January 25, 2019
End Date:February 25, 2025
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer

The purpose of this study is to evaluate the effectiveness of niraparib in combination with
abiraterone acetate and prednisone (AA-P) compared to AA-P plus placebo.

This study will assess efficacy and safety of niraparib in combination with AA-P for the
treatment of participants with metastatic prostate cancer. Niraparib is an orally available,
highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with
potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA
is a pro-drug of abiraterone and selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase
(CYP17), which is found in the testes and adrenals, as well as in prostate tissues and
tumors. In participants with metastatic prostate cancer, DNA-repair gene defects (DRD) are
identified in approximately 15 percent (%) to 20% of tumors. The study will consist of 4
phases: a prescreening phase for biomarker evaluation only, a screening phase, a double-blind
treatment phase, and a follow up phase. During the prescreening phase participants will be
evaluated for DRD and then will be assigned to one of the 2 cohorts based on their biomarker
status. Treatment will be administered daily and is planned to be continuous until disease
progression, unacceptable toxicity, death, or the sponsor terminates the study. Efficacy,
pharmacokinetics, biomarkers, participants reported outcomes and safety will be assessed. The
total duration of study will be approximately up to 73 months.

Inclusion Criteria:

- Deoxyribonucleic acid (DNA)-repair gene defects (DRD) status (as identified by the
sponsor's required assays) as follows:

1. Cohort 1: positive for DRD

2. Cohort 2: not positive for DRD (i.e. No DRD)

- Metastatic disease documented by positive bone scan or metastatic lesions on computed
tomography (CT) or magnetic resonance imaging (MRI)

- Progression of metastatic prostate cancer in the setting of castrate levels of
testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a
gonadotropin releasing hormone analog (GnRHa), or history of bilateral orchiectomy at
study entry as evidenced by prostate-specific antigen (PSA) progression or
radiographic progression

- Able to continue GnRHa during the study if not surgically castrate

- Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst
pain in last 24 hours)

Exclusion Criteria:

- Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP)
inhibitor

- Systemic therapy (example, enzalutamide, docetaxel) in the metastatic
castration-resistant prostate cancer (mCRPC) setting with the exception of less than 4
months of abiraterone acetate-Prednisone (AA-P) prior to randomization

- Symptomatic brain metastases

- History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia
(AML)

- Other prior malignancy (exceptions: adequately treated basal cell or squamous cell
skin cancer, superficial bladder cancer, or any other cancer in situ currently in
complete remission) <= 2 years prior to randomization, or malignancy that currently
requires active systemic therapy
We found this trial at
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Salem, Virginia 24153
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Vallejo, California 94589
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Bay Pines, Florida 33744
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Bethesda, Maryland 20817
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Boston, Massachusetts 02114
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1640 Avenida Pueyrredón
Buenos Aires, C1118
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Buenos Aires,
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545 Health Boulevard
Daytona Beach, Florida 32114
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Golden, Colorado 80401
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Hines, Illinois 60141
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Hines, IL
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Jacksonville, Florida 32209
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Kansas City, Missouri 64218
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Lancaster, Pennsylvania 17604
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Louisville, Kentucky 40207
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Mount Laurel, New Jersey 08054
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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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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Omaha, NE
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Pittsburgh, Pennsylvania 15213
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Salt Lake City, Utah 84106
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San Bernardino, California
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San Francisco, California 94143
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Syracuse, New York 13210
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Tacoma, Washington 98405
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Towson, MD
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Tucson, AZ
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Virginia Beach, Virginia 23642
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West Haven, Connecticut 06516
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