drugset / Trial / NCT05203172

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

NCT05203172 ↗

Phase 4 Recruiting 210 enrolled Pfizer
Non-randomizedParallel-groupOpen-labelTreatment

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 in 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 were not enrolled in a prior study of encorafenib or binimetinib. Participants who had enrolled but had stopped receiving the study treatment in a prior study cannot be enrolled in this study. Participants in the FLOTILLA study will receive study treatment at the same dose and frequency as in their prior study, for up to about 5 years.

Timeline

Start
2022-07-05
Primary completion
2029-07-31
Completion
2032-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody — Intravenous
Subject Binimetinib Small molecule — Oral
Subject Capecitabine Small molecule — Oral
Subject Cetuximab Monoclonal antibody — Intravenous
Subject Encorafenib Small molecule — Oral
Subject Irinotecan Small molecule — Intravenous
Subject Leucovorin Small molecule — Intravenous
Subject Nivolumab Monoclonal antibody — Intravenous
Subject Oxaliplatin Small molecule — Intravenous
Subject Pembrolizumab Monoclonal antibody — Intravenous
Subject Ribociclib Small molecule — Oral
Subject Vemurafenib Small molecule — Oral
Subject fluorouracil Small molecule — Intravenous

Indications