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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    148
  • sponsor
    Janssen Research & Development, LLC
Updated on 14 October 2020
Investigator
The Medical Research Network, LLC
Primary Contact
Chesapeake Urology Research Associates (9.3 mi away) Contact
+82 other location

Summary

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).

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.

Details
Treatment prednisone, abiraterone acetate, Prednisone 5 mg, Niraparib 200 mg, JNJ-63723283 240 mg, JNJ-63723283 480 mg, JNJ-63723283 Dose to be Determined, Abiraterone acetate 1000 mg, Cetrelimab 480 mg, Cetrelimab mg, Cetrelimab 240 mg
Clinical Study IdentifierNCT03431350
SponsorJanssen Research & Development, LLC
Last Modified on14 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have Prostatic Neoplasms, Castration-Resistant?
Participants willing to undergo all protocol-specified biopsies
Diagnosis of prostate adenocarcinoma as confirmed by the investigator
Inclusion Criteria for Combination 1A
Must have determination of biomarker (BM) positive by the sponsor's blood or tissue assay, or a previous local test result (from a Clinical Laboratory Improvement Amendments [CLIA]-certified or equivalent laboratory) and reviewed by the sponsor to confirm eligibility
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
Inclusion Criteria for Combination 1B
Combination 1B is closed to enrollment
Inclusion Criteria for Combination 2
Combination 2 is closed to enrollment
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

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 1
Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody
Active autoimmune disease
Combination 3
Symptomatic brain metastases
Prior disease progression during combination treatment with AA and PARPi. Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi-related toxicity
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