Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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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.

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.

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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE4

Study 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

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Peter MacCallum Cancer Centre

Select from list below to view details:

Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia

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Who is running the clinical trial?

Pfizer

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: Sub-Study C4221004C Continued treatment access for participants from the C4221004 (ARRAY CMEK162B2301, COLUMBUS) Encorafenib and Binimetinib study. Each participant will receive the same study treatment as received in the Parent Study.	Drug: Binimetinib, Drug: Encorafenib, Drug: Vemurafenib
EXPERIMENTAL: Sub-Study C4221005C Continued treatment access for participants from the C4221005 (ARRAY CMEK162X2110) Encorafenib and Binimetinib study. Each participant will receive the same study treatment as received in the Parent Study.	Drug: Binimetinib, Drug: Encorafenib, Drug: Ribociclib
EXPERIMENTAL: Sub-Study C4211001C / C4211003C Continued treatment access for participants from the C4211001 (ARRAY CMEK162×2201) and the C4211003 (ARRAY-162-311, MILO) Binimetinib studies. Each participant will receive the same study treatment as received in the Parent Study.	Drug: Binimetinib
EXPERIMENTAL: Sub-Study C4221003C / C4221006C / C4221013C Continued treatment access for participants from the C4221003 (ARRAY-818-103), C4221006 (ARRAY-818-201) and the C4221013 (ARRAY CLGX818X2109) Encorafenib and Binimetinib studies. Each participant will receive the same study treatment as received in the Parent Study.	Drug: Binimetinib, Drug: Encorafenib
EXPERIMENTAL: Sub-Study C4221009C / W00090 GE 2 01C Continued treatment access for participants from the C4221009 (ARRAY-818-302, BEACON) and W00090 GE 2 01 (ANCHOR CRC) Encorafenib, Binimetinib and Cetuximab studies. Each participant will receive the same study treatment as received in the Parent Study.	Drug: Binimetinib, Drug: Encorafenib, Biological: Cetuximab
EXPERIMENTAL: Sub-Study C4221008C Continued treatment access for participants from the C4221008 (ARRAY-818-202, PHAROS) Encorafenib and Binimetinib study. Each participant will receive the same study treatment as received in the Parent Study.	Drug: Binimetinib, Drug: Encorafenib
EXPERIMENTAL: Sub-Study C4221016C / C4221023C Continued treatment access for participants from the C4221016 (STARBOARD) and C4221023 (PORTSIDE) Encorafenib and Binimetinib studies. Each participant will receive the same study treatment as received in the Parent Study.	Drug: Binimetinib, Drug: Encorafenib, Biological: Pembrolizumab, Biological: Nivolumab
EXPERIMENTAL: Sub-Study C4221010C Continued treatment access for participant from the C4221010 (CLGX818X2101) Encorafenib study. Each participant will receive the same study treatment as received in the Parent Study.	Drug: Encorafenib
EXPERIMENTAL: Sub-Study C4221015C / C4221022C Continued treatment access for participants from the C4221015 (BREAKWATER) and C4221022 (SEAMARK) Encorafenib studies. Each participant will receive the same study treatment as received in the Parent Study.	Drug: Encorafenib, Biological: Cetuximab, Drug: 5-Fluorouracil, Drug: Leucovorin, Drug: Oxaliplatin, Drug: Irinotecan, Drug: Capecitabine, Biological: Bevacizumab

What is the study measuring?

Primary Outcome

Measure	Description	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

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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

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