The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials
Recruiting now · Phase 4
Conditions studied: Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT05203172
- Run by
- Pfizer
- People needed
- 46
- Starts
- 2022-07-05
- Expected to finish
- 2029-07-31
- Last updated by the study team
- 2026-04-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
Where it is running
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
- Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (enrolling)
- Investigational Drug Service Emory University Clinic — Atlanta, Georgia, United States (enrolling)
- Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (enrolling)
- Emory University Hospital — Atlanta, Georgia, United States (enrolling)
- Regions Hospital Pharmacy — Saint Paul, Minnesota, United States (enrolling)
- Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
- Barnes-Jewish Hospital — St Louis, Missouri, United States (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- Washington University — St Louis, Missouri, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
- HealthPartners Cancer Research Center — Saint Paul, Minnesota, United States (enrolling)
- Duke Cancer Center — Durham, North Carolina, United States (enrolling)
- Investigational Chemotherapy Service — Durham, North Carolina, United States (enrolling)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
- Liga Norte Riograndense Contra o Câncer — Natal, Rio Grande do Norte, Brazil (enrolling)
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia — Ijuí, Rio Grande do Sul, Brazil (enrolling)
- Fundação Pio XII - Hospital de Câncer de Barretos — Barretos, São Paulo, Brazil (enrolling)
- BP - A Beneficencia Portuguesa de São Paulo — São Paulo, São Paulo, Brazil (enrolling)
- Real e Benemerita Associacao Portuguesa de Beneficencia — São Paulo, São Paulo, Brazil (enrolling)
- University Health Network — Toronto, Ontario, Canada (enrolling)
- Vseobecna fakultni nemocnice v Praze — Prague, Praha 2, Czechia (enrolling)
Full record on ClinicalTrials.gov
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