NL-OMON50358已完成2 期
A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration- Resistant Prostate Cancer and DNA-Repair Anomalies - GALAHAD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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
排除标准
- •- 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
研究者
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