An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 402
- 试验地点
- 645
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
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 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.
研究组 & 干预措施
Darolutamide (BAY1841788)
Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.
干预措施: Darolutamide (Nubeqa, BAY1841788) (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 4 years
Incidence of treatment-emergent serious adverse events (TESAEs)
时间窗: Up to 4 years
Incidence of drug-related TEAEs
时间窗: Up to 4 years
Incidence of drug-related TESAEs
时间窗: Up to 4 years
次要结局
- Number of dose modifications(Up to 4 years)