EUCTR2019-003777-26-FI进行中（未招募）1 期
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Olaparib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment - ROSY-O
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
- 204
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
- Female
入选标准
- •1 Provision of signed and dated, written ICF.
- •2 Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AstraZeneca (AZ) compound that has met its endpoints or has otherwise stopped.
- •3 Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.
- •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 97
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 107
排除标准
- •1 Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
- •2 Currently receiving treatment with any prohibited medication(s).
- •3 Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •4 Permanent discontinuation from the parent study due to toxicity or disease progression.
- •5 Local access to commercially-available drug at no cost to the patient, as permitted by local/country regulation.
研究者
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