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

PHASE4RECRUITING

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.

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Study details:

This is an open-label, continuation study for participants receiving study intervention(s) in an encorafenib/binimetinib Parent Study. The study is being conducted under a Master Protocol for Encorafenib/Binimetinib Continuation Sub-Studies with an individual encorafenib/binimetinib continuation sub-study protocol for each eligible Parent Study. Approximately 75 participants from potentially qualifying Parent Studies will be included in this Encorafenib/Binimetinib Continuation study.

This continuation study includes multiple sub-study protocols to allow participants from each of the following parent studies: C4211001 - NCT01320085; C4211003 - NCT01849874; C4221003 - NCT03864042; C4221005 - NCT01543698; C4221006 - NCT03911869; C4221009 - NCT02928224; C4221010 - NCT01436656; C4221013 - NCT02159066; ANCHOR-CRC - NCT03693170.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-07-05

Primary completion: 2026-12-31

Study completion finish: 2026-12-31

Study type

TREATMENT

Phase

PHASE4

Trial ID

NCT05203172

Intervention or treatment

DRUG: Binimetinib only treatment

DRUG: Encorafenib only Treatment

DRUG: Encorafenib & Binimetinib Treatment

DRUG: Treatment of Encorafenib & Binimetinib & Ribociclib

DRUG: Treatment of Encorafenib & Binimetinib & Cetuximab

Conditions

• Solid Tumors

Condition: Solid Tumors
DRUG: Binimetinib only treatment and other drugs
Melbourne, Victoria, Australia
Sponsor: Pfizer

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Peter MacCallum Cancer Centre

Research sites nearby

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Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Binimetinib only treatment For those participants receiving binimetinib treatment in parent studies	DRUG: Binimetinib only treatment 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.
EXPERIMENTAL: Encorafenib only Treatment For those participants receiving encorafenib only treatment in parent studies	DRUG: Encorafenib only Treatment Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent Study.
EXPERIMENTAL: Encorafenib & Binimetinib Treatment For those participants receiving encorafenib \& binimetinib treatment in parent studies.	DRUG: Encorafenib & Binimetinib Treatment 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.
EXPERIMENTAL: Treatment of Encorafenib & Binimetinib & Ribociclib For those participants receiving treatment of encorafenib \& binimetinib \& ribociclib in parent studies	DRUG: Treatment of Encorafenib & Binimetinib & Ribociclib 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.
EXPERIMENTAL: Treatment of Encorafenib & Binimetinib & Cetuximab For those participants receiving treatment of encorafenib \& binimetinib \& cetuximab in parent studies	DRUG: Treatment of Encorafenib & Binimetinib & Cetuximab 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of participants with adverse events leading to permanent discontinuation of study intervention	Not Specified	Baseline up to approximately 5 years
Number serious adverse events reported for all participants	Not Specified	Baseline up to approximately 5 years

Secondary outcome

Frequently Asked Questions

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References

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