A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration- Resistant Prostate Cancer and DNA-Repair Anomalies
- Conditions
- progressive metastatic castration resistant prostate cancer1002766410036958
- Registration Number
- NL-OMON50358
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
- Histologically confirmed prostate cancer (mixed histology is acceptable, with
the exception of the small cell phenotype, which is excluded)
- Received taxane based chemotherapy for the treatment of metastatic prostate
cancer with evidence of disease progression on or after treatment, or
discontinued taxane based chemotherapy due to an adverse event.
- Received a second-generation or later AR-targeted therapy (e.g. 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. Bioallelic
DNA-repair anomaly based on a sponsor-validated blood or tissue assay. b.
Germline pathogenic BRCA1 or BRCA2 by any test.
- Progression of metastatic prostate cancer in the setting of castrate levels
of testosteron or history of bilateral orchiectomy at study entry
- Prior treatment with a PARP inhibitor
- Prior platinum-based chemotherapy for the treatment of prostate cancer
- Known history or current diagnosis of myelodysplastic syndrome (MDS) or Acute
myeloid leukemia (AML)
- symptomatic or impending cord compression
- symptomatic brain metastases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Objective response rate (ORR) of soft tissue (visceral or nodal disease) as<br /><br>defined by RECIST 1.1 with no evidence of bone progression according to the<br /><br>PCWG3 criteria in participants with either biallelic Breast Cancer Gene 1 or<br /><br>Breast Cancer Gene 2 or germline BRCA. ORR in participants with with measurable<br /><br>mCRPC and DNA-repair anomalies. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Objective response rate (ORR) of soft tissue (visceral or nodal disease) as<br /><br>defined by RECIST 1.1 with no evidence of bone progression according to the<br /><br>PCWG3 criteria<br /><br>- CTC response defined as CTC = 0 per 7,5ml blookd at 8 weeks post-baseline<br /><br>- OS: time from enrollment to death from any cause<br /><br>- As defined by PCWG3:<br /><br>* rPFS: time from enrollment to radiographic progression or death from any<br /><br>cause, whichever occurs first<br /><br>* Time to radiographic progression<br /><br>* Time to PSA progression<br /><br>* Time to symptomatic skeletal event (SSE)<br /><br><br /><br><br /><br>- Incidence of adverse events<br /><br>- Clinical laboratory test results<br /><br><br /><br><br /><br>Duration of objective response: time from complete response (CR) or partial<br /><br>response (PR) to radiographic progression of disease</p><br>
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