EUCTR2016-000300-28-IT进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Histologically confirmed diagnosis of prostate cancer.
- •2. Candidate for treatment with enzalutamide or abiraterone with
- •documented evidence of mCRPC.
- •3. Subjects must have progressed on prior new hormonal agent (e.g.
- •abiraterone acetate and/or enzalutamide) for the treatment of mCRPC.
- •4. Ongoing therapy with LHRH analog or bilateral orchiectomy.
- •5. Radiographic progression at study entry while on androgen
- •deprivation therapy (or after bilateral orchiectomy).
- •6. Qualifying HRR mutation in tumor tissue by the Lynparza HRR Assay
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Any previous treatment with PARP inhibitor, including olaparib
- •2. Subjects who have any previous treatment with DNA-damaging
- •cytotoxic chemotherapy.
- •3. 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.
- •4. Subjects with myelodysplastic syndrome/acute myeloid leukemia or
- •with features suggestive of MDS/AML.
- •5. *Subjects with known brain metastases.
研究者
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