Last updated on July 2020

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


Brief description of study

The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).

Detailed Study Description

This multicenter study will evaluate safety and efficacy of niraparib in combination with other anti-cancer agents. Combination 1 will combine niraparib with the anti-programmed cell death protein (PD)-1 monoclonal antibody cetrelimab, in participants with mCRPC. Combination 1 has 2 parts: in Part 1 (dose selection), participants will be enrolled to establish RP2D doses of niraparib and cetrelimab; and Part 2 (dose expansion) will evaluate the combination therapy in an expanded number of participants into 2 cohorts (biomarker positive or biomarker negative). Combination 2 is closed to enrollment. Combination 3 will evaluate the relative bioavailability (BA) of niraparib and AA in combination. In pharmacokinetics (PK) assessment phase niraparib will be administered in combination with AA and in extension phase niraparib plus AA will be administered in combination with prednisone. Combinations 1 and 2 will have 4 phases: A Pre-screening Phase, a Screening Phase, a Treatment Phase, and a Follow-up Phase; Combination 3 has 3 phases: A Screening Phase, A PK Assessment Phase, and an Extension Phase. Study evaluations will include efficacy, PK, PK/pharmacodynamics, biomarkers, safety and tolerability.

Clinical Study Identifier: NCT03431350

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Massachusetts General

Boston, MA United States
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Thomas Jefferson University

Philadelphia, PA United States
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MUSC-Hollings Cancer Center

Charleston, SC United States
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Carolina Urologic Research Center

Myrtle Beach, SC United States
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Utah Cancer Specialists

Salt Lake City, UT United States
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Urology of Virginia, PLCC

Virginia Beach, VA United States
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ZNA Middelheim

Antwerpen, Belgium
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Az Groeninge

Kortrijk, Belgium
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Guy's Hospital

London, United Kingdom
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Southampton General Hospital

Southampton, United Kingdom
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University of Florida

Jacksonville, FL United States
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Intermountain Healthcare

Saint George, UT United States
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Florida Hospital

Orlando, FL United States
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First Urology, PSC

Jeffersonville, IN United States
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Houston Metro Urology

Houston, TX United States
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Soroka Hospital

Beer-Sheva, Israel
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Urology Centers Of Alabama

Homewood, AL United States
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Mayo Clinic Arizona

Phoenix, AZ United States
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Clinical Research Solutions, LLC

Middleburg Heights, OH United States
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Oregon Urology Institute

Springfield, OR United States
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Urologic Consultants of SE PA

Bala-Cynwyd, PA United States
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Urology Associates

Nashville, TN United States
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Centre Hospitalier Lyon Sud

Pierre Benite Cedex, France
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HIA Begin

Saint Mande, France
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Recruitment Status: Open


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