RecruitingPHASE4INTERVENTIONAL

Pediatric Long-Term Follow-up and Rollover Study

This study is designed for children and young people who have previously taken part in other clinical trials and were treated with the medicines dabrafenib and/or trametinib for a type of brain cancer. It's often called a 'rollover' study because participants are moving from one study to another. The main goal is to check on their health and how they are doing in the long term after receiving these treatments. This helps doctors understand how well the medications work over time and if there are any long-lasting effects or side effects. It's a way to continue monitoring patients' progress and collect important information after their initial treatment period has finished in the earlier trial.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Novartis Pharmaceuticals

Enrolment target

165

Start

04 Nov 2019

Estimated completion

05 Nov 2026

What is this study about?

This study is for young people who have previously been involved in other clinical trials that tested medications called dabrafenib and/or trametinib for certain types of brain tumors. Think of it as a continuation, or 'rollover', from those earlier trials.

The main purpose is to carefully watch how these young patients are doing over a longer period. Doctors want to understand the long-term effects of these specific medicines. This includes seeing how well the treatment continues to manage their condition and whether there are any ongoing side effects or any new health issues that might pop up later on. This helps doctors gather a complete picture of the treatment's impact on a patient's health.

By following patients for a longer time, researchers can learn a lot about the safety and effectiveness of these drugs. This information is really important for developing better treatments in the future and for helping doctors make the best decisions for other young patients with similar conditions.

Key takeaways

This study is for young people who were in previous trials for brain tumors.
It checks on your health long-term after treatment with dabrafenib and/or trametinib.
You'll continue to receive your current study medication if it's helping you.
Regular check-ups will monitor your health and any side effects.
Your progress helps doctors learn more about these treatments for the future.

Who may be eligible?

This study is for children and young people, from age 1 up to 99, who have already taken part in a specific Novartis clinical trial (like CTMT212X2101, CDRB436G2201, or CDRB436A2102) involving dabrafenib and/or trametinib. You'll need to have given your permission to join, either yourself or through your parents/guardians, and be able to keep up with the study's appointments and plans.

To be included for ongoing treatment, you must currently be receiving dabrafenib and/or trametinib in one of these previous Novartis studies, and your doctor must believe that continuing the treatment will help you. If you were on a different treatment arm in a previous study, you might be able to switch to receive dabrafenib and/or trametinib in this study.

You would not be able to join if you stopped treatment permanently in the earlier study for any reason, or if the medicines (dabrafenib and/or trametinib) are now widely available and funded for your condition in the UK. Also, if you have severe side effects from the previous treatment that haven't cleared up yet, you might not be able to start treatment in this study, though this could change if your side effects improve.

Quick self-check

Did I previously take part in a Novartis study like CTMT212X2101, CDRB436G2201, or CDRB436A2102?
Was I treated with dabrafenib and/or trametinib in that study?
Do I currently receive dabrafenib and/or trametinib and my doctor believes it's still beneficial?
Am I able to attend regular appointments and follow the study plan?
Do I understand that I cannot join if I permanently stopped treatment in the previous study or if the drug is already widely available for my condition?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll continue to receive either dabrafenib, trametinib, or a combination of both, depending on what you were taking in the previous study. You'll have regular hospital visits, as decided by your doctors, to check on your health and how the treatment is working. These visits might include physical examinations, blood tests, and possibly scans. The study will aim to follow your health for a long period, which could be many years, to understand the lasting effects of the medication. The exact number and type of visits will be explained by the study team.

Potential risks and benefits

Potential benefits of taking part include continuing to receive treatment that your doctor believes is helping you, and being closely monitored by medical professionals. This close monitoring can provide reassurance and allow for early detection of any new health concerns. As with all medications, there's a chance of side effects, some of which you might have experienced before. The study will continue to monitor these carefully. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (55)

Phoenix Children s Hospital
Phoenix, United States· Active not recruiting
Childrens National Hospital
Washington D.C., United States· Active not recruiting
Nicklaus Childrens Hospital
Miami, United States· Active not recruiting
Indiana Uni School of Medicine
Indianapolis, United States· Active not recruiting
Johns Hopkins Hospital
Baltimore, United States· Active not recruiting
Dana Farber Cancer Institute
Boston, United States· Active not recruiting
University of Minnesota
Minneapolis, United States· Active not recruiting
Memorial Sloan Kettering Cancer Center
New York, United States· Recruiting
Memorial Sloan Kettering Cancer Ctr
New York, United States· Active not recruiting
Cinn Children Hosp Medical Center
Cincinnati, United States· Active not recruiting
St Jude Childrens Research Hospital
Memphis, United States· Active not recruiting
Texas Childrens Hospital
Houston, United States· Completed

+43 more sites — see the official record for the full list.

Common questions

What is a 'rollover' study?

It means you are moving from a previous clinical trial into this new study to continue follow-up and possibly treatment.

What are dabrafenib and trametinib?

These are specific medications that were tested in earlier studies for certain types of brain tumors.

Will I get new medication?

You will likely continue to receive the same medication (dabrafenib and/or trametinib) you were getting in the previous study, if your doctor thinks it's still beneficial.

How long will I be in the study?

This is a long-term follow-up study, so you could be involved for many years, with regular check-ups.

What happens if I want to stop?

You can choose to leave the study at any time without it affecting your medical care or relationship with your doctors.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

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