The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials
- Registration Number
- NCT05203172
- Lead Sponsor
- Pfizer
- 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 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.
- 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 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 46
- 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.
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Binimetinib only treatment Binimetinib only treatment For those participants receiving binimetinib treatment in parent studies Encorafenib only Treatment Encorafenib only Treatment For those participants receiving encorafenib only treatment in parent studies Encorafenib & Binimetinib Treatment Encorafenib & Binimetinib Treatment For those participants receiving encorafenib \& binimetinib treatment in parent studies. Treatment of Encorafenib & Binimetinib & Ribociclib Treatment of Encorafenib & Binimetinib & Ribociclib For those participants receiving treatment of encorafenib \& binimetinib \& ribociclib in parent studies Treatment of Encorafenib & Binimetinib & Cetuximab Treatment of Encorafenib & Binimetinib & Cetuximab For those participants receiving treatment of encorafenib \& binimetinib \& cetuximab in parent studies
- Primary Outcome Measures
Name Time Method Number of participants with adverse events leading to permanent discontinuation of study intervention Baseline up to approximately 5 years Number serious adverse events reported for all participants Baseline up to approximately 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
HealthPartners Cancer Research Center
🇺🇸Saint Paul, Minnesota, United States
Regions Hospital Pharmacy
🇺🇸Saint Paul, Minnesota, United States
HealthPartners Specialty Center
🇺🇸Saint Paul, Minnesota, United States
MSK Basking Ridge
🇺🇸Basking Ridge, New Jersey, United States
Rockefeller Outpatient Pavilion (53rd Street)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Liga Norte Riograndense Contra o Câncer
🇧🇷Natal, RIO Grande DO Norte, Brazil
Scroll for more (41 remaining)St. Joseph's Hospital and Medical Center🇺🇸Phoenix, Arizona, United States