The FLOTILLA Study: Continued Access to Encorafenib and Binimetinib for Participants from Previous Trials
Sponsor: Pfizer
ClinicalTrials ID:NCT05203172
This study allows participants from previous trials of encorafenib and/or binimetinib to continue receiving these medications if they are still benefiting from them. The study also includes safety monitoring.
Patient Parameters
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Program Overview
The FLOTILLA study is designed to provide ongoing access to the medications encorafenib and binimetinib for participants who were part of earlier clinical trials and are still experiencing benefits from these treatments. Participants must have been part of a previous study involving these drugs to join the FLOTILLA study. Those who have stopped treatment in prior studies cannot participate. Participants will continue to receive the same dose and frequency of the medications as in their previous study, for up to about 5 years.
Description
This study is open to participants who were receiving encorafenib and/or binimetinib in a previous clinical trial and are still benefiting from the treatment. The study is part of a larger program that allows participants from various earlier studies to continue their treatment under a unified protocol. Around 75 participants from eligible previous studies will be included in this continuation study. The study includes several sub-study protocols for participants from specific previous trials, identified by their clinical trial numbers.
Eligibility Criteria
Inclusion Criteria
- Participants must be currently receiving encorafenib and/or binimetinib in a previous study and still benefiting from it, as determined by the study doctor.
- Participants should not have any severe or intolerable side effects related to the study treatment.
- Participants must agree to follow specific guidelines related to reproduction as outlined in the study protocol.
Exclusion Criteria
- Any medical condition that, according to the study doctor or sponsor, would prevent the participant from joining the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| St. Joseph's Hospital and Medical Center | 85004 | Phoenix | Arizona |
| St. Joseph's Hospital and Medical Center | 85013 | Phoenix | Arizona |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| HealthPartners Cancer Research Center | 55101 | Saint Paul | Minnesota |
| Regions Hospital Pharmacy | 55101 | Saint Paul | Minnesota |
| HealthPartners Specialty Center | 55130 | Saint Paul | Minnesota |
| MSK Basking Ridge | 07920 | Basking Ridge | New Jersey |
| Rockefeller Outpatient Pavilion (53rd Street) | 10022 | New York | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
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