The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials
Phase 4
Recruiting
- Conditions
- Solid Tumors
- Registration Number
- NCT05203172
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Any participant who is receiving study intervention and deriving clinical benefit<br> (as determined by the principal investigator) in an encorafenib/binimetinib Parent<br> Study, with no ongoing NCI CTCAE version 4.03 Grade =3 or intolerable Grade 2 AEs<br> considered to be related to study treatment.<br><br> - Participants must agree to follow the reproductive criteria as outlined in the<br> applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.<br><br>Exclusion Criteria:<br><br> - Any medical reason that, in the opinion of the investigator or sponsor, precludes<br> the participant from inclusion in the study.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with adverse events leading to permanent discontinuation of study intervention;Number serious adverse events reported for all participants
- Secondary Outcome Measures
Name Time Method