EUCTR2010-022278-15-DE进行中（未招募）1 期
A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy And Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have A Confirmed Genetic BRCA1 And/Or BRCA2 Mutation
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- All
入选标准
- •1. Confirmed BRCA1 or BRCA2 mutation
- •2. Confirmed malignant solid tumours for which no standard treatment exists
- •3. At least one lesion (measurable and/or non measurable) at baseline that can be accurately assessed by CT/MRI and is suitable for repeated assessment at follow up visits
- •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 260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •1. Any previous treatment with a PARP inhibitor, including olaparib
- •2. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorbtion of the study medication
- •3. Patients receiving any systematic chemotherapy, radiotherapy (except for palliative reasons) within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used)
研究者
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