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NCT05203172 Clinical Trial

The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

Solid Tumors Clinical Trial

Official title:
ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05203172
Other study ID # C4221026
Secondary ID FLOTILLA2021-004
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 5, 2022
Est. completion date December 31, 2026

Study information
Verified date March 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 46
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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
Country Name City State
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Brazil Fundação Pio XII - Hospital de Câncer de Barretos Barretos SÃO Paulo
Brazil ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ijui RIO Grande DO SUL
Brazil Liga Norte Riograndense Contra o Câncer Natal RIO Grande DO Norte
Brazil BP - A Beneficencia Portuguesa de São Paulo Sao Paulo SÃO Paulo
Brazil Real e Benemerita Associacao Portuguesa de Beneficencia Sao Paulo SÃO Paulo
Canada Jewish General Hospital Montreal Quebec
Canada Princess Margaret Cancer Centre Toronto Ontario
Czechia Vseobecna fakultni nemocnice v Praze Prague 2 Praha 2
France Hopital Claude Huriez - CHU de Lille Lille Nord
France Gustave Roussy Villejuif Val-de-marne
Germany Charité Universitaetsmedizin Berlin - Campus Mitte Berlin
Germany Otto-von-Guericke-Universitat Magdeburg Magdeburg Sachsen-anhalt
Germany Universitaetsklinikum Tuebingen Tübingen Baden-württemberg
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Israel Rambam Health Care Campus Haifa Hatsafon
Italy Instituto Tumori Giovanni Paolo II Bari Puglia
Italy Istituto Europeo di Oncologia IRCCS Milano
Italy Istituto Nazionale Tumori IRCCS Fondazione Pascale Napoli
Italy Istituto Nazionale Tumori Regina Elena Rome Roma
Japan Aichi Cancer Center Hospital Nagoya Nagoya, Aichi
Korea, Republic of Seoul National University Hospital Seoul Seoul-teukbyeolsi [seoul]
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Seoul-teukbyeolsi [seoul]
Netherlands Radboudumc Nijmegen Gelderland
Netherlands Isala, locatie Zwolle Zwolle
Portugal Instituto Português de Oncologia de Lisboa Francisco Gentil Lisbon Lisboa
Portugal Instituto Português de Oncologia do Porto Francisco Gentil, EPE Porto
Slovakia Narodny onkologicky ustav Bratislava Bratislavský KRAJ
Spain CHUAC-Hospital Teresa Herrera A Coruña A Coruña [LA Coruña]
Spain Institut Català d'Oncologia (ICO) - Badalona Badalona Barcelona [barcelona]
Spain Hospital Clínic de Barcelona Barcelona Catalunya [cataluña]
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona Barcelona [barcelona]
Spain Hospital Universitario Arnau de Vilanova de Lleida Lleida Lleida [lérida]
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Universitario HM Sanchinarro Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Madrid, Comunidad DE
Spain H.R.U Málaga - Hospital General Málaga
Spain Hospital Universitario Central de Asturias Oviedo
United Kingdom Rosemere Cancer Centre - Royal Preston Hospital Preston Lancashire
United Kingdom Rosemere Cancer Centre - Royal Preston Hospital Preston
United Kingdom Royal Preston Hospital Preston
United States MSK Basking Ridge Basking Ridge New Jersey
United States Massachusetts General Hospital Boston Massachusetts
United States Memorial Sloan Kettering Cancer Center New York New York
United States Rockefeller Outpatient Pavilion (53rd Street) New York New York
United States St. Joseph's Hospital and Medical Center Phoenix Arizona
United States St. Joseph's Hospital and Medical Center Phoenix Arizona
United States HealthPartners Cancer Research Center Saint Paul Minnesota
United States HealthPartners Specialty Center Saint Paul Minnesota
United States Regions Hospital Pharmacy Saint Paul Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Portugal,  Slovakia,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events leading to permanent discontinuation of study intervention Baseline up to approximately 5 years
Primary Number serious adverse events reported for all participants Baseline up to approximately 5 years
See also
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Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
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Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Completed NCT02759640 - A Phase I Trial of HS-10241 in Solid Tumors Phase 1
Withdrawn NCT01940601 - Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors Phase 2

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