Encorafenib/binimetiib master protocol: an open-label continuation study for participants continuing from encorafenib/binimetinib clinical studies. ;Sub-study 1: An open-label study for continued treatment access for participants from the C4211001 (Array CMEK162X2201) and the C4211003 (Array-162-311, MILO) Binimetinib studies.;Sub-study 2: An open-label study for continued treatment access for participants from the C4221004 (Array CMEK162B2301, Columbus) Encorafenib and Binimetinib study;Sub-s
Phase 4
Recruiting
- Conditions
- (Maligne) solide tumoren, niet-reseceerbare huidkanker, niet-kleincellige longkankercancer
- Registration Number
- NL-OMON53566
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3
Inclusion Criteria
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 intolerable Grade 2 AEs considered to be related to study
treatment.
Exclusion Criteria
1. Any medical reason that, in the opinion of the investigator or sponsor,
precludes the participant from inclusion in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• AEs leading to permanent discontinuation of binimetinib or encorafenib<br /><br><br /><br>• SAEs</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>