RecruitingPHASE4INTERVENTIONAL

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

The FLOTILLA study aims to keep providing certain cancer medicines, encorafenib and binimetinib, to people who have already been taking them in previous clinical trials. This is for participants who are still doing well on the treatment, as decided by their study doctor. You can't join this study if you haven't been in a previous trial for these specific medicines. If you were in an earlier study but stopped taking the treatment, you also can't join. Participants will continue to receive the same dose and combination of medicines they were on before, potentially for up to five years, while doctors also keep an eye on their health.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Pfizer

Enrolment target

Start

05 Jul 2022

Estimated completion

31 Jul 2029

Solid Tumors

What is this study about?

Imagine you're taking part in a study for a new medicine, and it's really helping you. What happens when that study finishes? The FLOTILLA study is designed to answer that question, specifically for people with solid tumours who have been receiving treatments called encorafenib and/or binimetinib.

The main idea behind FLOTILLA is to make sure people who are benefiting from these study medicines can continue to receive them. It's like an extension of your previous trial. Doctors want to ensure that if the treatment is working well for you, you don't have to stop taking it just because the first study has ended. They will also continue to monitor your health and how you're responding to the treatment.

This study is for a specific group of people: those who have already participated in other clinical trials involving encorafenib and/or binimetinib and whose study doctor believes they are still gaining a benefit from these medicines. It connects several previous studies, creating a way for participants to keep receiving their treatment while their health is carefully tracked. This approach helps ensure ongoing care and allows researchers to gather more information over a longer period.

Key takeaways

This study helps you keep receiving specific cancer medicines if they've been helping you in a previous trial.
It's only for people who have already been in related studies for encorafenib and/or binimetinib.
Your doctor must confirm the treatment is still benefiting you to join.
You'll continue with the same treatment you had before, potentially for up to five years.
Your health will be closely monitored throughout the study.
You can stop participating at any time.

Who may be eligible?

To be considered for the FLOTILLA study, you need to have already been taking part in an earlier clinical trial for encorafenib and/or binimetinib. Your study doctor must also agree that the medicines are still helping you, and you shouldn't be experiencing any very serious side effects that are considered linked to the treatment.

It's important to understand that if you haven't been in one of these previous trials, or if you were in one but stopped receiving the study medicine, you won't be able to join FLOTILLA. This study is specifically for continuing treatment for those already benefitting.

You also need to agree to follow certain rules about family planning, if that applies to you, as outlined in the study details.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I already been part of a clinical study using encorafenib or binimetinib?
Is my study doctor confident that the treatment is still helping me?
Am I free from very serious side effects linked to the treatment right now?
Am I willing to follow any family planning guidelines if they apply to me?
Did I continue receiving the study medicine until my previous trial ended, without stopping early?

Answer every question to see your result.

What does participation involve?

If you join the FLOTILLA study, you will continue to receive the same combination and dose of encorafenib and/or binimetinib that you were taking in your previous study. This will be given to you for up to about five years, as long as your study doctor believes it continues to help you.

Throughout the study, you'll have regular visits to the clinic so the medical team can keep a close eye on your health. They will check how you are responding to the treatment and look out for any side effects. These visits and checks are important for your safety and to understand the long-term effects of the medication. The study aims to maintain your access to the medication without interruption, while ensuring your well-being is a top priority.

Potential risks and benefits

Taking part in FLOTILLA allows you to continue receiving treatment that your doctor believes is benefiting you, potentially for an extended period. With any medicine, there are always potential risks; you might experience side effects, some of which could be bothersome or, in rare cases, serious. The study team will closely monitor you for any side effects. Remember, joining any study is your choice, and you are free to leave the study at any time without needing to give a reason, and this won't affect your future medical care.

Locations (67)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

St. Joseph's Hospital and Medical Center
Verified postcode
Phoenix, United States· Recruiting
St. Joseph's Hospital and Medical Center
Verified postcode
Phoenix, United States· Recruiting
Emory University Hospital Midtown
Verified postcode
Atlanta, United States· Recruiting
Emory University Hospital
Verified postcode
Atlanta, United States· Recruiting
Investigational Drug Service Emory University Clinic
Verified postcode
Atlanta, United States· Recruiting
Winship Cancer Institute of Emory University
Verified postcode
Atlanta, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
HealthPartners Cancer Research Center
Verified postcode
Saint Paul, United States· Recruiting
Regions Hospital Pharmacy
Verified postcode
Saint Paul, United States· Recruiting
Siteman Cancer Center
Verified postcode
St Louis, United States· Recruiting
Barnes-Jewish Hospital
Verified postcode
St Louis, United States· Recruiting
Washington University School of Medicine
Verified postcode
St Louis, United States· Recruiting

Common questions

What is the main goal of the FLOTILLA study?

Its main goal is to continue providing specific cancer medicines (encorafenib and binimetinib) to people who are already receiving benefit from them in an earlier study.

Can anyone join the FLOTILLA study?

No, you can only join if you have already been part of a previous clinical trial for encorafenib and/or binimetinib and your doctor says the treatment is still helping you.

How long will I receive treatment in this study?

You could receive the treatment for up to about five years, as long as it continues to be effective and safe for you.

What if I stopped taking the study medicine in my previous trial?

If you had stopped the treatment in an earlier study, you would not be able to join FLOTILLA.

Will my doses or medicines change in this study?

No, you will receive the same doses and combinations of medicines you were taking in your previous study.

How to find out more

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.