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

StatusRecruiting
PhasePhase 4
SponsorPfizer
Started

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Record History

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  1. Site details revised at 4 of 77 sites
  2. Enrollment increased: 46 → 210 participants Show 6 more changesShow less
    • Trial sites expanded: 67 → 77 locations
    • Study completion pushed from Jul 31, 2029 to Jun 30, 2032
    • Interventions modified
    • Trial arms changed: 5 → 9
    • Study description expanded, about 19 words
    • Eligibility criteria expanded, about 3 words
  3. Study sites: 69 to 67v30
  4. Study sites: 68 to 69v29
  5. Study sites: 67 to 68v28
Show 26 earlier versionsHide 26 earlier versions
  1. Study sites: 63 to 67v27
  2. Primary and study completion dates: Dec 31, 2026 to Jul 31, 2029
    • Study sites: 57 to 63
    v26
  3. Site details revised at 4 of 57 sitesv25
  4. Study sites: 56 to 57v24
  5. Study sites: 52 to 56v23
  6. Re-verified, no change to tracked fieldsv22
  7. Site details revised at 5 of 52 sitesv21
  8. Site details revised at 5 of 52 sitesv20
  9. Study sites: 45 to 52v19
  10. Study sites: 43 to 45
    • Primary and study completion dates: May 3, 2027 to Dec 31, 2026
    v18
  11. Study sites: 41 to 43v17
  12. Site details revised at 6 of 41 sitesv16
  13. Site details revised at 6 of 41 sitesv15
  14. Study sites: 33 to 41v14
  15. Study sites: 24 to 33v13
  16. Study sites: 23 to 24v12
  17. Study sites: 13 to 23v11
  18. 2 versions Re-verified since Dec 27, 2022, no change to tracked fieldsv9-v10
  19. Study sites: 12 to 13v8
  20. Study sites: 10 to 12v7
  21. Study sites: 8 to 10v6
  22. Study sites: 5 to 8v5
  23. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    v4
  24. Start date: May 31, 2022 to Jul 5, 2022
    • Primary and study completion dates: Mar 29, 2027 to May 3, 2027
    v3
  25. Enrollment target: 75 to 46
    • Start date: Mar 31, 2022 to May 31, 2022
    • Primary and study completion dates: Dec 28, 2026 to Mar 29, 2027
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
438 trials monitored
See 32 trials at risk
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.
Trial Details
NCT Number NCT05203172
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Solid Tumors
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov