A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:March 2, 2018
End Date:August 31, 2021
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to establish the recommended phase 2 dose (RP2D) of niraparib
combination therapies of Part 1 and to evaluate the antitumor activity and safety of
niraparib combination therapies of Part 2.

This multicenter study will evaluate safety and efficacy of niraparib in combination with
other anti-cancer agents. Two combinations are being studied: the first combination study
will combine niraparib with the anti-programmed cell death protein (PD)-1 monoclonal
antibody, JNJ-63723283 in participants with metastatic castration-resistant prostate cancer
(mCRPC). The second combination will combine niraparib with abiraterone acetate plus
prednisone (AA-P) in mCRPC participants with DNA-repair gene defects (DRD). Combination 1 has
2 parts: in Part 1 (dose selection), participants will be enrolled to explore 2 doses of
niraparib and JNJ-63723283; and Part 2 (dose expansion) will evaluate the combination therapy
in an expanded number of participants. In Part 2, participants will be enrolled into 2
cohorts based on biomarker status. Combination 2 has only 1 part (Part 2) and no Part 1. In
Part 2, participants will be enrolled into 4 cohorts (breast cancer gene [BRCA] biallelic
loss [2A], other DRD biallelic loss [2B], BRCA monoallelic loss [2C], and other DRD
monoallelic loss [2D]). Each combination in the study will have 4 phases: A Prescreening
Phase, a Screening Phase, a Treatment Phase, and a Follow-up Phase. Study evaluations will
include efficacy, pharmacokinetic (PK), PK/pharmacodynamics, biomarkers, safety and
tolerability.

Inclusion Criteria:

- Participants willing to undergo all protocol-specified biopsies

- Diagnosis of prostate adenocarcinoma as confirmed by the investigator

Combination 1:

- Must have determination of biomarker (BM) status for DNA-repair gene defects (DRD)
(either BM positive [+] or BM negative [-]) by the sponsor's blood or tissue assay

- Participants must have measurable disease as defined by response evaluation criteria
in solid tumors (RECIST) 1.1 (soft tissue lesion of greater than or equal to (>=) 10
millimeter (mm) in the long axis or extrapelvic lymph node of >=15 mm in the short
axis)

- Must have previously received at least 1, but no more than 2, lines of novel androgen
receptor (AR)-targeted therapy (that is, abiraterone acetate with prednisone,
enzalutamide) for metastatic castration-resistant prostate cancer (mCRPC).
Participants must have had at least 4 weeks of AR-targeted therapy

Combination 2:

- Must be biomarker positive for DRD by either the sponsor's blood or tissue assay

- Must have progressed on 1 prior line of novel AR-targeted therapy (that is,
abiraterone acetate with prednisone, enzalutamide) for mCRPC. Prior treatment with
taxane-based therapy and AR-targeted therapy outside of the mCRPC setting is allowed

Exclusion Criteria:

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

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

- Active malignancy (exceptions: adequately treated basal cell or squamous cell skin
cancer, superficial bladder cancer, or any other cancer in situ currently remission)
less than or equal to (<=) 2 years prior to enrollment

- Active infection requiring systemic therapy

- Allergies, hypersensitivity, or intolerance to niraparib or the corresponding
excipients
We found this trial at
16
sites
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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164 Moorselbaan
Aalst, 9300
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Boston, Massachusetts 02114
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Charleston, South Carolina 29425
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Denver, Colorado 80211
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500 Westchester Avenue
Harrison, New York 10604
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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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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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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Salt Lake City, UT
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Salt Lake City, Utah 84106
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Towson, MD
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Virginia Beach, Virginia 23642
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