JPRN-jRCT2031230602招募中2 期
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.
Tanigawa Takahiko0 个研究点目标入组 1 人开始时间: 2024年1月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 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
入排标准
- 年龄范围
- >= 10age old 至 ot applicable(—)
- 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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