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

Conditions

• Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Binimetinib only treatment — DRUG
  Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Parent Studies C4211001 and C4211003 with water irrespective of food, continuously, starting on Day 1.
• Encorafenib only Treatment — DRUG
  Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent Study.
• Encorafenib & Binimetinib Treatment — DRUG
  Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.
• Treatment of Encorafenib & Binimetinib & Ribociclib — DRUG
  Encorafenib capsule and ribociclib capsules or tablets will be co-administered orally QD with binimetinib tablets BID. The study drugs will be administered as a flat-fixed dose, and not by body weight or body surface area.
• Treatment of Encorafenib & Binimetinib & Cetuximab — DRUG
  Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.

Study Details

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.

Key Dates

Start date

Jul 5, 2022

Status verified

Apr 2026

Primary completion

Jul 31, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

46 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Binimetinib only treatment
  For those participants receiving binimetinib treatment in parent studies
• Experimental: Encorafenib only Treatment
  For those participants receiving encorafenib only treatment in parent studies
• Experimental: Encorafenib & Binimetinib Treatment
  For those participants receiving encorafenib \& binimetinib treatment in parent studies.
• Experimental: Treatment of Encorafenib & Binimetinib & Ribociclib
  For those participants receiving treatment of encorafenib \& binimetinib \& ribociclib in parent studies
• Experimental: Treatment of Encorafenib & Binimetinib & Cetuximab
  For those participants receiving treatment of encorafenib \& binimetinib \& cetuximab in parent studies

Primary Outcome Measure

Number of participants with adverse events leading to permanent discontinuation of study intervention [ Time Frame: Baseline up to approximately 5 years ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (18)

Find similar trials in Phoenix, AZ

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