The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials
ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES
3 other identifiers
interventional
46
17 countries
69
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2022
Longer than P75 for phase_4
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
January 24, 2022
CompletedStudy Start
First participant enrolled
July 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
March 18, 2026
March 1, 2026
7.1 years
January 10, 2022
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (5)
Binimetinib only treatment
EXPERIMENTALFor those participants receiving binimetinib treatment in parent studies
Encorafenib only Treatment
EXPERIMENTALFor those participants receiving encorafenib only treatment in parent studies
Encorafenib & Binimetinib Treatment
EXPERIMENTALFor those participants receiving encorafenib \& binimetinib treatment in parent studies.
Treatment of Encorafenib & Binimetinib & Ribociclib
EXPERIMENTALFor those participants receiving treatment of encorafenib \& binimetinib \& ribociclib in parent studies
Treatment of Encorafenib & Binimetinib & Cetuximab
EXPERIMENTALFor those participants receiving treatment of encorafenib \& binimetinib \& cetuximab in parent studies
Interventions
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 will be self-administered at the same dose level as that received in the C4221010 Parent Study.
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.
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.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (69)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85004, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Investigational Drug Service Emory University Clinic
Atlanta, Georgia, 30322, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, 55101, United States
Regions Hospital Pharmacy
Saint Paul, Minnesota, 55101, United States
HealthPartners Specialty Center
Saint Paul, Minnesota, 55130, United States
Siteman Cancer Center
St Louis, Missouri, 63108, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Washington University
St Louis, Missouri, 63110, United States
MSK Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Rockefeller Outpatient Pavilion (53rd Street)
New York, New York, 10022, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Investigational Chemotherapy Service
Durham, North Carolina, 27710, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14.780-070, Brazil
BP - A Beneficencia Portuguesa de São Paulo
São Paulo, São Paulo, 01321-001, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, São Paulo, 01323-030, Brazil
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Vseobecna fakultni nemocnice v Praze
Prague, Praha 2, 12808, Czechia
Hopital Claude Huriez - CHU de Lille
Lille, NORD, 59037, France
Gustave Roussy
Villejuif, Val-de-marne, 94800, France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Otto-von-Guericke-Universitat Magdeburg
Magdeburg, Saxony-Anhalt, 39120, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117, Germany
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Rambam Health Care Campus
Haifa, Northern District, 3109601, Israel
Instituto Tumori Giovanni Paolo II
Bari, Apulia, 70124, Italy
Istituto Nazionale Tumori Regina Elena
Rome, ROMA, 00144, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, 10060, Italy
Istituto Oncologico Veneto IRCCS
Padua, Veneto, 35128, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138, Italy
Istituto Europeo di Oncologia IRCCS
Milan, 20141, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131, Italy
Radboudumc
Nijmegen, Gelderland, 6525 GA, Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, North Holland, 1066 CX, Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)
Amsterdam, North Holland, 1066 CX, Netherlands
Isala, locatie Zwolle
Zwolle, 8025 AB, Netherlands
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisbon, Lisbon District, 1099-023, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
N.N.Petrov Research Institute of Oncology
Saint Petersburg, Sankt-Peterburg, 197758, Russia
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
Moscow, 115478, Russia
N.N.Petrov Research Institute of Oncology
Saint Petersburg, 197758, Russia
Narodny onkologicky ustav
Bratislava, Bratislava Region, 833 10, Slovakia
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea
CHUAC-Hospital Teresa Herrera
A Coruña, A Coruña [LA Coruña], 15006, Spain
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [barcelona], 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Clinic de Barcelona
Barcelona, Catalunya [cataluña], 08008, Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], 08036, Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Lleida [lérida], 25198, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, 28222, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
H.R.U Málaga - Hospital General
Málaga, 29011, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
Preston, Lancashire, PR2 9HT, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2022
First Posted
January 24, 2022
Study Start
July 5, 2022
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
July 31, 2029
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.