At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Binimetinib (drug), Encorafenib (drug), Vemurafenib (drug), Ribociclib (drug)
- How long the study runs
- Study runs about 119 months (dates as stated)
- About the drug or intervention
- Binimetinib — drug: Binimetinib is administered orally twice a day. · Encorafenib — drug: Encorafenib is administered orally once a day. · Vemurafenib — drug: Vemurafenib is administered orally twice a day. · Ribociclib — drug: Ribociclib is administered orally once a day. · Cetuximab — biological: Cetuximab is administered intravenously (IV) every 2 weeks. · Pembrolizumab — biological: Pembrolizumab is administered intravenously (IV) every 3 weeks. · Nivolumab — biological: Nivolumab is administered intravenously (IV) every 4 week. · 5-Fluorouracil — drug: 5-FU is administered intravenously (IV) every 2 weeks. · Leucovorin — drug: Leucovorin is administered intravenously (IV) every 2 weeks. · Oxaliplatin — drug: Oxaliplatin is administered intravenously (IV) every 2 or 3 weeks. · Irinotecan — drug: Irinotecan is administered intravenously (IV) every 2 weeks. · Capecitabine — drug: Capecitabine is administered orally twice a day for 14 consecutive days, followed by 7 days off. · Bevacizumab — biological: Bevacizumab will be administered intravenously (IV), if applicable.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 210
- Started
- 2022-07-05
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for solid tumors
- • Phase4 - 210 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with solid tumors
Where?
- • Preston - Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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 in 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 were not enrolled in a prior study of encorafenib or binimetinib. Participants who had enrolled but had stopped receiving the study treatment in a prior study cannot be enrolled in this study. Participants in the FLOTILLA study will receive study treatment at the same dose and frequency as in their prior study, for up to about 5 years.
More detail
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 individual encorafenib/binimetinib continuation sub-study protocols that cover each eligible Parent Study. Up to approximately 210 participants from 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; C4221004 - NCT01909453; C4221005 - NCT01543698; C4221006 - NCT03911869; C4221008 - NCT03915951; C4221009 - NCT02928224; C4221010 - NCT01436656; C4221013 - NCT02159066; ANCHOR-CRC - NCT03693170; C4221015 - NCT04607421; C4221016 - NCT04657991; C4221022 - NCT05217446; C4221023 - NCT05926960
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Participants must agree to follow the reproductive criteria as outlined in the applicable Encorafenib/Binimetinib...
Who cannot take part
- ✗\- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion...
See the full criteria
Where Is This Study? (1 UK site)
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
Preston PR2 9HT, United Kingdom
How to Get in Touch
Pfizer CT.gov Call Center
Sponsor contactCONTACT