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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 185
- 试验地点
- 108
- 主要终点
- Safety follow up
研究概览
简要总结
The rationale of the ROSY-O study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.
详细描述
ROSY-O is an open label, non-randomised, multicentre,international trial for patients who have completed a parent study using olaparib and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated, written ICF.
- •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.
- •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.
排除标准
- •Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
- •Currently receiving treatment with any prohibited medication(s).
- •Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Permanent discontinuation from the parent study due to toxicity or disease progression.
- •Local access to commercially-available drug at no cost to the patient is permitted by local regulation.
研究组 & 干预措施
Olaparib
Treatment
干预措施: Olaparib (Drug)
结局指标
主要结局
Safety follow up
时间窗: Baseline up to approximately 10 years
Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.
次要结局
未报告次要终点