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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03431350
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib 200 mg — DRUG
    Participants will receive niraparib 200 mg orally.
  • Cetrelimab 240 mg — DRUG
    Participants will receive cetrelimab 240 mg IV every 2 weeks.
  • Cetrelimab 480 mg — DRUG
    Participants will receive cetrelimab 480 mg IV every 4 weeks.
  • Abiraterone acetate 1000 mg — DRUG
    Participants will receive AA 1000 mg orally.
  • Prednisone 5 mg — DRUG
    Participants will receive prednisone 5 mg orally.

Study Details

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).

Key Dates

Start date
Mar 2, 2018
Status verified
Jun 2026
Primary completion
Aug 31, 2021
Completion
Dec 31, 2026

Study Design

Enrollment
136 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination 1:Dose Selection: Niraparib + cetrelimab (Part 1)
    Dose regimen 1: The participants will receive niraparib 200 milligram (mg) orally once daily in combination with cetrelimab 240 mg intravenously (IV) once every 2 weeks. Dose regimen 2: The participants will receive niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV once every 4 weeks in 28-day treatment cycles until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. The safety evaluation team (SET) will determine if an additional cohort is necessary, based on the data from dose regimens 1 and 2. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.
  • Experimental: Combination 1:Dose Expansion: Niraparib + cetrelimab (Part 2)
    Participants will be assigned to either Cohort 1A (Biomarker \[BM\] positive \[+\]) or Cohort 1B (BM negative \[-\]) and will receive established RP2D of cetrelimab and niraparib, in Part 2 until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. A futility analysis will be performed for the Cohort 1B after 10 BM- participants are enrolled in Part 2. This cohort will be closed if the response is less than predetermined response rate as outlined in the protocol. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.
  • Experimental: Combination 2: Dose Expansion: Niraparib + AA-P (Part 2)
    Participants will be assigned to one of 4 cohorts based on biomarker status - Cohort 2A (BRCA biallelic loss), 2B (other DRD biallelic loss), 2C (BRCA monoallelic loss), or 2D (other DRD monoallelic loss), and will receive niraparib 200 mg once daily in combination with abiraterone acetate 1000 mg (4\*250 mg) plus 10 mg prednisone (5 mg twice daily) throughout treatment phase. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.
  • Experimental: Combination 3: Niraparib + AA-P
    Participants will be assigned to one of three cohorts to receive AA-P with or without niraparib. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.

Primary Outcome Measure

Combination 1: Part 1: Number of Participants With Specified Toxicity [ Time Frame: Cycle 1 (28 days) ]

Locations (19)

FacilityCityStateZIPSite coordinators
Urological Associates of Southern Arizona, P.C.TucsonArizona85741-
The Urology Center of ColoradoDenverColorado80211-
Mayo Clinic - Division Of Hematology/oncologyJacksonvilleFlorida32224-
First Urology, PSCJeffersonvilleIndiana47130-
Chesapeake Urology Research AssociatesTowsonMaryland21204-
Michigan Institute of UrologyTroyMichigan48084-
New York Oncology HematologyAlbanyNew York12208-
Memorial Sloan Kettering Cancer Center 1HarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical Center (UPMC)PittsburghPennsylvania15232-
MUSC-Hollings Cancer CenterCharlestonSouth Carolina29425-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Urology AssociatesNashvilleTennessee37209-
Houston Metro UrologyHoustonTexas77027-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
Urology of Virginia, PLCCVirginia BeachVirginia23462-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin5379200-

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Urological Associates of Southern Arizona, P.C.· Tucson, AZThe Urology Center of Colorado· Denver, COMayo Clinic - Division Of Hematology/oncology· Jacksonville, FLFirst Urology, PSC· Jeffersonville, INChesapeake Urology Research Associates· Towson, MDMichigan Institute of Urology· Troy, MI

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