Clinical Trials /

An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

NCT02854436

Description:

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
  • Official Title: A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Clinical Trial IDs

  • ORG STUDY ID: CR108208
  • SECONDARY ID: 64091742PCR2001
  • SECONDARY ID: 2016-002057-38
  • NCT ID: NCT02854436

Conditions

  • Prostatic Neoplasms

Interventions

DrugSynonymsArms
NiraparibJNJ-64091742Niraparib

Purpose

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.

Detailed Description

      This is a multicenter and open-label (participants and researchers are aware of the treatment
      that participants are receiving) study that consists of 4 phases; a Prescreening Phase for
      biomarker evaluation only, a Screening Phase, a Treatment Phase (Cycle 1 Day 1 and will
      continue until the study drug is discontinued), and a Follow-up Phase (every 3 months after
      end of treatment visit). Participants will be monitored for safety during the study period,
      and up to 30 days after the last dose of study drug.
    

Trial Arms

NameTypeDescriptionInterventions
NiraparibExperimentalParticipants will receive 300 milligram (mg) niraparib (3 capsules*100 mg) orally once daily.
  • Niraparib

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed prostate cancer (mixed histology is acceptable, with the
             exception of the small cell pure phenotype, which is excluded)

          -  Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer
             with evidence of disease progression on or after treatment, or discontinued from a
             taxane-based chemotherapy due to an adverse event

          -  Received a second-generation or later androgen receptor (AR)-targeted therapy (for
             example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the
             treatment of metastatic prostate cancer with evidence of disease progression or
             non-metastatic castration-resistant prostate cancer with evidence of subsequent
             metastasis

          -  Biomarker-positive by at least one of the following criteria: (a) Biallelic
             deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or
             tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test
             (somatic local results must be confirmed as positive by the sponsor-validated assay
             before dosing)

          -  Progression of metastatic prostate cancer in the setting of castrate levels of
             testosterone or history of bilateral orchiectomy at study entry

        Exclusion Criteria:

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

          -  Prior platinum-based chemotherapy for the treatment of prostate cancer

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

          -  Symptomatic or impending cord compression

          -  Symptomatic brain metastases
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Screening, Cycle 1 (each cycle of 28 days) Day 1 (every 8 weeks for the first 6 months and then every 12 weeks thereafter) till Follow-up Phase
Safety Issue:
Description:ORR of soft tissue disease with no evidence of bone progression in participants with in Breast Cancer gene 1 (BRCA1) or gene 2 (BRCA2). ORR is defined as proportion of participants with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to 4 years and 6 months
Safety Issue:
Description:ORR in participants with measurable metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies. ORR of soft tissue (visceral or nodal disease) as defined by RECIST 1.1 with no evidence of bone progression according to the Prostate Cancer Working Group 3 (PCWG3) criteria.
Measure:Circulating Tumor Cells (CTC) Response
Time Frame:From Screening till End of Treatment (30 {+/- 5} days of last dose -up to 4 years and 6 months)
Safety Issue:
Description:CTC response defined as CTC=0 per 7.5 milliliter (mL) blood at 8 weeks post-baseline in participants with baseline CTC greater than (>) 0.
Measure:Overall Survival (OS)
Time Frame:From enrollment to completion of study (up to 4 years and 6 months)
Safety Issue:
Description:OS is defined as time from enrollment to death from any cause.
Measure:Radiographic Progression-Free Survival (rPFS)
Time Frame:From enrollment to completion of study (up to 4 years and 6 months)
Safety Issue:
Description:rPFS is defined as time from enrollment to radiographic progression or death.
Measure:Time to Prostate Specific Antigen (PSA) Progression
Time Frame:From enrollment to completion of study (up to 4 years and 6 months)
Safety Issue:
Description:First PSA increase that is 25 percent (%) or greater and an absolute increase of 2 nanogram/milliliter (ng/mL) or more above the nadir.
Measure:Time to Symptomatic Skeletal Event (SSE)
Time Frame:From enrollment to completion of study (up to 4 years and 6 months)
Safety Issue:
Description:Time to SSE: time from enrollment to first symptomatic fracture, radiation or surgery to bone, or spinal cord compression.
Measure:Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame:From enrollment to completion of study (up to 4 years and 6 months)
Safety Issue:
Description:
Measure:Duration of Objective Response
Time Frame:From complete response (CR) or partial response (PR) to radiographic progression of disease (up to 4 years 6 months)
Safety Issue:
Description:Duration of objective response is defined as time from complete response or partial response to radiographic progression of disease, unequivocal clinical progression or death, whichever occurs first.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Janssen Research & Development, LLC

Trial Keywords

  • Prostate cancer
  • CRPC
  • Metastatic castrate-resistant prostate cancer
  • Prostate neoplasm
  • Galahad
  • Niraparib
  • DNA anomalies
  • DNA defect
  • PARP inhibitor
  • PARPi

Last Updated

January 30, 2020