The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials
NCT ID: NCT05203172
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
46 participants
INTERVENTIONAL
2022-07-05
2029-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
The details of study intervention and duration of treatment are specified in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Binimetinib only treatment
For those participants receiving binimetinib treatment in parent studies
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
For those participants receiving encorafenib only treatment in parent studies
Encorafenib only Treatment
Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent Study.
Encorafenib & Binimetinib Treatment
For those participants receiving encorafenib \& binimetinib treatment in parent studies.
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
For those participants receiving treatment of encorafenib \& binimetinib \& ribociclib in parent studies
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
For those participants receiving treatment of encorafenib \& binimetinib \& cetuximab in parent studies
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants must agree to follow the reproductive criteria as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
HealthPartners Specialty Center
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
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
Padua, 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
Napoli, , Italy
Radboudumc
Nijmegen, Gelderland, Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, North Holland, 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
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FLOTILLA
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509408-13-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4221026
Identifier Type: -
Identifier Source: org_study_id