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

Trial Status: Active

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).

Inclusion Criteria

  • Inclusion Criteria for Combination 3: - Diagnosed with mCRPC, who in the opinion of the investigator may benefit from treatment in Combination 3 of this study - Able to continue gonadotropin releasing hormone analogue (GnRHa) therapy during the study if not surgically castrate (that is, subjects who has not undergone bilateral orchiectomy). - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1 - Toxicity associated with prior chemotherapy or radiotherapy has resolved to Grade <= 1 (except alopecia or Grade <= 2 neuropathy) at screening - Participant must agree not to donate sperm while on study treatment, and for 3 months following the last dose of study treatment Exclusion Criteria: - History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) - Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: non-muscle invasive bladder cancer; skin cancer (non-melanoma or melanoma); breast cancer; malignancy that is considered cured with minimal risk of recurrence - Active infection requiring systemic therapy - Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients Combination 3: - Symptomatic brain metastases - Prior disease progression during combination treatment with AA and poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi-related toxicity

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

South Carolina

Charleston
Medical University of South Carolina
Status: COMPLETED

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

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 will combine niraparib with abiraterone acetate plus prednisone

(AA-P) in mCRPC participants with DNA-repair gene defects (DRD). Combination 3 will evaluate

the relative bioavailability (BA) of niraparib and AA in combination. In a pharmacokinetics

(PK) assessment phase, niraparib and AA will be administered, and in an extension phase,

niraparib and AA-P will be administered. 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.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Janssen Research & Development, LLC

  • Primary ID CR108406
  • Secondary IDs NCI-2018-00392, 64091742PCR2002, 2017-003552-23
  • Clinicaltrials.gov ID NCT03431350