ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 46
- 试验地点
- 107
- 主要终点
- Number of participants with adverse events leading to permanent discontinuation of study intervention
研究概览
简要总结
The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib.
All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib.
Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years.
详细描述
This is an open-label, continuation study for participants receiving study intervention(s) in an encorafenib/binimetinib Parent Study. The study is being conducted under a Master Protocol for Encorafenib/Binimetinib Continuation Sub-Studies with an individual encorafenib/binimetinib continuation sub-study protocol for each eligible Parent Study. Approximately 75 participants from potentially qualifying Parent Studies will be included in this Encorafenib/Binimetinib Continuation study.
This continuation study includes multiple sub-study protocols to allow participants from each of the following parent studies: C4211001 - NCT01320085; C4211003 - NCT01849874; C4221003 - NCT03864042; C4221005 - NCT01543698; C4221006 - NCT03911869; C4221009 - NCT02928224; C4221010 - NCT01436656; C4221013 - NCT02159066; ANCHOR-CRC - NCT03693170
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 intolerable Grade 2 AEs considered to be related to study treatment.
- •Participants must agree to follow the reproductive criteria as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
排除标准
- •Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
研究组 & 干预措施
Encorafenib & Binimetinib Treatment
For those participants receiving encorafenib & binimetinib treatment in parent studies.
干预措施: Encorafenib & Binimetinib Treatment (Drug)
Binimetinib only treatment
For those participants receiving binimetinib treatment in parent studies
干预措施: Binimetinib only treatment (Drug)
Encorafenib only Treatment
For those participants receiving encorafenib only treatment in parent studies
干预措施: Encorafenib only Treatment (Drug)
Treatment of Encorafenib & Binimetinib & Ribociclib
For those participants receiving treatment of encorafenib & binimetinib & ribociclib in parent studies
干预措施: Treatment of Encorafenib & Binimetinib & Ribociclib (Drug)
Treatment of Encorafenib & Binimetinib & Cetuximab
For those participants receiving treatment of encorafenib & binimetinib & cetuximab in parent studies
干预措施: Treatment of Encorafenib & Binimetinib & Cetuximab (Drug)
结局指标
主要结局
Number of participants with adverse events leading to permanent discontinuation of study intervention
时间窗: Baseline up to approximately 5 years
Number serious adverse events reported for all participants
时间窗: Baseline up to approximately 5 years
次要结局
未报告次要终点