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

NCT05203172

RecruitingPhase 4

Sponsor: Pfizer

Conditions: Solid Tumors

Interventions: Binimetinib only treatment, Encorafenib only Treatment, Encorafenib & Binimetinib Treatment, Treatment of Encorafenib & Binimetinib & Ribociclib, Treatment of Encorafenib & Binimetinib & Cetuximab

Countries: United States, Australia, Brazil, Canada, Czechia, France, Germany, Hungary

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (67)
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Boston, Massachusetts, United States
  • Saint Paul, Minnesota, United States
  • Saint Paul, Minnesota, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • Basking Ridge, New Jersey, United States
  • New York, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Durham, North Carolina, United States
  • Melbourne, Victoria, Australia
  • Natal, Rio Grande do Norte, Brazil
  • Ijuí, Rio Grande do Sul, Brazil
  • Barretos, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Prague, Praha 2, Czechia
  • Lille, NORD, France
  • Villejuif, Val-de-marne, France
  • + 37 more on CT.gov