JPRN-jRCT2041220160尚未招募4 期
AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES - FLOTILLA Study
Oki Kosuke0 个研究点目标入组 3 人开始时间: 2023年3月14日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3
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
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade 3 or more or intolerable Grade 2 AEs considered to be related to study treatment.
- •2. Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females) of the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
- •3. Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
- •4. Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
排除标准
- •1. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
研究者
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