Clinical trial NCT05203172: The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials
Official title: ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Solid Tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-01-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant will continue to receive the same study treatment regimen at the same dose level as that received in the Parent Studies.

The details of study intervention and duration of treatment are specified in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with adverse events leading to permanent discontinuation of study intervention
timeFrame: Baseline up to approximately 5 years
measure: Number serious adverse events reported for all participants
timeFrame: Baseline up to approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Paul
country: United States
facility: HealthPartners Cancer Research Center
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital Pharmacy
state: Minnesota
city: Saint Paul
country: United States
facility: HealthPartners Specialty Center
state: Minnesota
city: Basking Ridge
country: United States
facility: MSK Basking Ridge
state: New Jersey
city: New York
country: United States
facility: Rockefeller Outpatient Pavilion (53rd Street)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer
state: RIO Grande DO Norte
city: Ijui
country: Brazil
facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: SÃO Paulo
city: Sao Paulo
country: Brazil
facility: BP - A Beneficencia Portuguesa de São Paulo
state: SÃO Paulo
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia
state: SÃO Paulo
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Prague 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
state: Praha 2
city: Lille
country: France
facility: Hopital Claude Huriez - CHU de Lille
state: Nord
city: Villejuif
country: France
facility: Gustave Roussy
state: Val-de-marne
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden-württemberg
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universitat Magdeburg
state: Sachsen-anhalt
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: Hatsafon
city: Bari
country: Italy
facility: Instituto Tumori Giovanni Paolo II
state: Puglia
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
state: Roma
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Nagoya, Aichi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [seoul]
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Zwolle
country: Netherlands
facility: Isala, locatie Zwolle
city: Lisbon
country: Portugal
facility: Instituto Português de Oncologia de Lisboa Francisco Gentil
state: Lisboa
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE
city: Moscow
country: Russian Federation
facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: N.N.Petrov Research Institute of Oncology
state: Sankt-peterburg
city: Moscow
country: Russian Federation
facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
city: Saint Petersburg
country: Russian Federation
facility: N.N.Petrov Research Institute of Oncology
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
state: Bratislavský KRAJ
city: A Coruña
country: Spain
facility: CHUAC-Hospital Teresa Herrera
state: A Coruña [LA Coruña]
city: Badalona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Badalona
state: Barcelona [barcelona]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [barcelona]
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalunya [cataluña]
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova de Lleida
state: Lleida [lérida]
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid, Comunidad DE
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Málaga
country: Spain
facility: H.R.U Málaga - Hospital General
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Preston
country: United Kingdom
facility: Rosemere Cancer Centre - Royal Preston Hospital
state: Lancashire
city: Preston
country: United Kingdom
facility: Rosemere Cancer Centre - Royal Preston Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: