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

Pfizer

Status and phase: Enrolling; Phase 4

Conditions: Solid Tumors

Treatments: Drug: Encorafenib & Binimetinib Treatment; Drug: Encorafenib only Treatment; Drug: Treatment of Encorafenib & Binimetinib & Ribociclib; Drug: Binimetinib only treatment; Drug: Treatment of Encorafenib & Binimetinib & Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05203172

C4221026

2023-509408-13-00 (Registry Identifier)

FLOTILLA (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

46 participants in 5 patient groups

Binimetinib only treatment

Experimental group

Description:

For those participants receiving binimetinib treatment in parent studies

Treatment:

Drug: Binimetinib only treatment

Encorafenib only Treatment

Experimental group

Description:

For those participants receiving encorafenib only treatment in parent studies

Treatment:

Drug: Encorafenib only Treatment

Encorafenib & Binimetinib Treatment

Experimental group

Description:

For those participants receiving encorafenib \& binimetinib treatment in parent studies.

Treatment:

Drug: Encorafenib & Binimetinib Treatment

Treatment of Encorafenib & Binimetinib & Ribociclib

Experimental group

Description:

For those participants receiving treatment of encorafenib \& binimetinib \& ribociclib in parent studies

Treatment:

Drug: Treatment of Encorafenib & Binimetinib & Ribociclib

Treatment of Encorafenib & Binimetinib & Cetuximab

Experimental group

Description:

For those participants receiving treatment of encorafenib \& binimetinib \& cetuximab in parent studies

Treatment:

Drug: Treatment of Encorafenib & Binimetinib & Cetuximab