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.
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
Interventions
Drug | Synonyms | Arms |
---|
Niraparib | JNJ-64091742 | Niraparib |
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), a Follow-up Phase (every 3 months after end
of treatment visit), and a Long-term Extension Phase (until participants no longer derive
benefit from treatment or until further notification on different means of study treatment).
Participants will be monitored for safety during the study period, and up to 30 days after
the last dose of study drug.
Trial Arms
Name | Type | Description | Interventions |
---|
Niraparib | Experimental | Participants will receive 300 milligram (mg) niraparib (3 capsules*100 mg) orally once daily. | |
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 either biallelic Breast Cancer gene 1 (BRCA1) or Breast Cancer gene 2 (BRCA2) or germline BRCA. 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. |
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: | Active, not 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
August 13, 2021