jRCT2031230602进行中(未招募)不适用
A single arm, open-label, multicenter Phase 2 study of regorafenib in participants who have been treated in a previous Bayer-sponsored regorafenib study (monotherapy or combination treatment) that has reached the primary completion endpoint or the main data analysis or has been stopped prematurely.
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 1
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
- 10age old over 至 No limit(—)
- 性别
- All
入选标准
- •Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving regorafenib as study treatment.
- •Participant is currently benefiting from treatment with regorafenib monotherapy. All participants must meet criteria to initiate a subsequent cycleof therapy, as determined by the guidelines of the feeder protocol.
- •Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and notrequiring further treatment interruption by the investigator.
排除标准
- •Ineligibility, for medical reasons, to start the subsequent cycle in the respective feeder study.
- •Participants with a beta-human chorionic gonadotropin (hCG) test result consistent with pregnancy.
- •Participants are using one or more of the prohibited medications listed in the respective feeder study protocol.
- •Participant has been previously permanently discontinued from regorafenib treatment.
研究者
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