Share
Save
The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials
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
Exclusion criteria
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
Find a site
Closest Location:
Peter MacCallum Cancer Centre
Research sites nearby
Select from list below to view details:
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
| DRUG: Binimetinib only treatment
|
EXPERIMENTAL: Encorafenib only Treatment
| DRUG: Encorafenib only Treatment
|
EXPERIMENTAL: Encorafenib & Binimetinib Treatment
| DRUG: Encorafenib & Binimetinib Treatment
|
EXPERIMENTAL: Treatment of Encorafenib & Binimetinib & Ribociclib
| DRUG: Treatment of Encorafenib & Binimetinib & Ribociclib
|
EXPERIMENTAL: Treatment of Encorafenib & Binimetinib & Cetuximab
| DRUG: Treatment of Encorafenib & Binimetinib & Cetuximab
|
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
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!