跳至主要内容
临床试验/jRCT2031230602
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.

Bayer Yakuhin, Ltd.0 个研究点目标入组 1 人开始时间: 2024年3月15日最近更新:

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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