Status:
RECRUITING
The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials
Lead Sponsor:
Pfizer
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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 Encorafe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05203172
Start Date
July 5 2022
End Date
July 31 2029
Last Update
December 18 2025
Active Locations (67)
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1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85004
2
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
3
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
4
Emory University Hospital
Atlanta, Georgia, United States, 30322