NL-OMON50358
Completed
Phase 2
A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration- Resistant Prostate Cancer and DNA-Repair Anomalies - GALAHAD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- 10036958
- Sponsor
- Janssen-Cilag
- Enrollment
- 6
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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.
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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