NL-OMON45674已完成3 期
A phase III, open label, randomized study to assess the efficacy and safety of Olaparib (Lynparza*)versus Enzalutamide or Abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations - PROfound
Astra Zeneca0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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 diagnosis of prostate cancer
- •- Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
- •- Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of mCRPC.
- •- Ongoing therapy with LHRH analog or bilateral orchiectomy.
- •- Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
- •- Qualifying HRR mutation in tumor tissue.
排除标准
- •- Any previous treatment with PARP inhibitor, including olaparib
- •- Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy (prior taxane chemotherapy allowed)
- •- Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for >=5 years
- •- Subjects with known brain metastases
研究者
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