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The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials
Sponsor: Pfizer
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.
Official title: ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2022-07-05
Completion Date
2029-07-31
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Binimetinib only treatment
Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Parent Studies C4211001 and C4211003 with water irrespective of food, continuously, starting on Day 1.
Encorafenib only Treatment
Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent Study.
Encorafenib & Binimetinib Treatment
Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.
Treatment of Encorafenib & Binimetinib & Ribociclib
Encorafenib capsule and ribociclib capsules or tablets will be co-administered orally QD with binimetinib tablets BID. The study drugs will be administered as a flat-fixed dose, and not by body weight or body surface area.
Treatment of Encorafenib & Binimetinib & Cetuximab
Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.
Locations (67)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Investigational Drug Service Emory University Clinic
Atlanta, Georgia, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 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
Siteman Cancer Center
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Washington University
St Louis, Missouri, 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
Duke Cancer Center
Durham, North Carolina, United States
Investigational Chemotherapy Service
Durham, North Carolina, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
BP - A Beneficencia Portuguesa de São Paulo
São Paulo, São Paulo, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, São Paulo, Brazil
University Health Network
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Vseobecna fakultni nemocnice v Praze
Prague, Praha 2, Czechia
Hopital Claude Huriez - CHU de Lille
Lille, NORD, France
Gustave Roussy
Villejuif, Val-de-marne, France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Otto-von-Guericke-Universitat Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, Germany
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
Rambam Health Care Campus
Haifa, Northern District, Israel
Instituto Tumori Giovanni Paolo II
Bari, Apulia, Italy
Istituto Nazionale Tumori Regina Elena
Rome, ROMA, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, Italy
Istituto Oncologico Veneto IRCCS
Padova, Veneto, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Italy
Istituto Europeo di Oncologia IRCCS
Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Italy
Radboudumc
Nijmegen, Gelderland, Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, North Holland, Netherlands
Isala, locatie Zwolle
Zwolle, Netherlands
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisbon, Lisbon District, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal
N.N.Petrov Research Institute of Oncology
Saint Petersburg, Sankt-Peterburg, Russia
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
Moscow, Russia
N.N.Petrov Research Institute of Oncology
Saint Petersburg, Russia
Narodny onkologicky ustav
Bratislava, Bratislava Region, Slovakia
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
CHUAC-Hospital Teresa Herrera
A Coruña, A Coruña [LA Coruña], Spain
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [barcelona], Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Hospital Clinic de Barcelona
Barcelona, Catalunya [cataluña], Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Lleida [lérida], Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
H.R.U Málaga - Hospital General
Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
Preston, Lancashire, United Kingdom