jRCT2031200304进行中（未招募）不适用
An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies (Darolutamide roll-over study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Male
入选标准
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
- •Participants who have not met any treatment discontinuation criteria outlined in the feeder study protocol.
- •Willingness to continue practicing acceptable methods of birth control during the study.
排除标准
- •Participant is unable to comply with the requirements of the study.
- •Negative benefit/ risk ratio as determined by the investigator.
- •Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.
结局指标
主要结局
-
Safety
次要结局
未报告次要终点
研究者
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