
"He went through six operations and was placed on a clinical trial so he could try new treatments.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called dabrafenib. It is for children and teenagers who have a that has got worse or come back despite having
. A solid tumour is any cancer apart from
.
The trial is for children and teenagers up to the age of 18. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.
In some solid tumours, there is a change () in a gene called BRAF. The BRAF gene makes a protein that affects how cancers divide and grow. Dabrafenib is a drug that blocks the action of the BRAF protein (a BRAF inhibitor).
The aims of this study are to
You may be able to enter this trial if
You cannot enter this trial if you
As well as the above, you can’t enter the 2nd part of the trial if you have already had dabrafenib or a similar drug.
This phase 1/2 trial will recruit nearly 85 children and young people all together. It is in 2 parts. Everybody joining the trial has dabrafenib.
In part 1, the researchers are looking for the highest dose of dabrafenib that people between 1 year and 18 years can have.
The first few patients taking part will have a low dose of dabrafenib. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study. Part 1 has recruited enough patients and is now closed.
In part 2, the researchers want to learn more about the side effects, what happens to dabrafenib in your body, and whether it helps children who have solid tumours with a BRAF gene mutation. Everybody joining this part of the trial will have the highest safe dose found in part 1.
Dabrafenib is a capsule that you take twice a day. If you can’t swallow capsules, you can have the drug as a liquid. The trial team will give you more information about exactly how and when to take the drug.
As long as you don’t have bad side effects, you can carry on having dabrafenib for as long as it helps you.
You see the trial team and have some tests before you start the trial treatment. The tests include
The trial team need a sample of your tumour to check if it has the specific change to the BRAF gene. They will get a sample of tissue that was removed when you had surgery or a in the past. But if there isn’t a sample available, you will need to have a new biopsy to be able to take part in the trial.
You go to hospital once a week for the first 4 weeks of treatment. After that, you go every 4 to 12 weeks for the rest of the time you have the trial treatment.
You have regular blood tests throughout the trial. And you will have more heart traces and heart scans. The trial team may ask you to have more CT or MRI scans.
When you stop taking dabrafenib, you see the trial team again and have a physical examination, blood tests, a heart trace and a heart scan. You will also have a CT or MRI scan if you haven’t had one recently.
The researchers may ask you to have another biopsy. But you don’t have to have this biopsy if you don’t want to.
Your doctor may also want you to have your skin examined 2 months after you stop taking dabrafenib.
As dabrafenib is a new drug, there may be side effects we don’t know about yet. In adults, the most common side effects seen so far have been
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Lynley Marshall
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer
Novartis
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"He went through six operations and was placed on a clinical trial so he could try new treatments.”