A Rollover Study to Provide Continued Treatment With M6620
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs) and Treatment Related AEs
研究概览
简要总结
The main purpose of the study was to monitor the safety of participant receiving long-term treatment of Berzosertib as monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ongoing treatment in Vertex study VX13-970-
- •Participant must be able to understand and provide written informed consent.
- •Participant must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
排除标准
- •Participants experiencing disease progression or unacceptable toxicity at the time of transition into the this study.
研究组 & 干预措施
Part A1: Berzosertib
干预措施: Berzosertib (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Treatment Related AEs
时间窗: Up to 6 years
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-related AEs: reasonably related to the study intervention.
次要结局
未报告次要终点