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

Use our guide to learn which trials are right for you!

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
30
sites
Kansas City, Missouri 64218
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Vallejo, California 94589
?
mi
from
Vallejo, CA
Click here to add this to my saved trials
Bay Pines, Florida 33744
?
mi
from
Bay Pines, FL
Click here to add this to my saved trials
Bethesda, Maryland 20817
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
1640 Avenida Pueyrredón
Buenos Aires, C1118
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
545 Health Boulevard
Daytona Beach, Florida 32114
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
Golden, Colorado 80401
?
mi
from
Golden, CO
Click here to add this to my saved trials
Hines, Illinois 60141
?
mi
from
Hines, IL
Click here to add this to my saved trials
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...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32209
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
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...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Lancaster, Pennsylvania 17604
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Mount Laurel, New Jersey 08054
?
mi
from
Mount Laurel, NJ
Click here to add this to my saved trials
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...
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Salem, Virginia 24153
?
mi
from
Salem, VA
Click here to add this to my saved trials
Salt Lake City, Utah 84106
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Bernardino, California
?
mi
from
San Bernardino, CA
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
?
mi
from
Towson, MD
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Virginia Beach, Virginia 23642
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
West Haven, Connecticut 06516
?
mi
from
West Haven, CT
Click here to add this to my saved trials