
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing masitinib with imatinib as the first drug treatment for gastrointestinal stromal tumours that can’t be removed with surgery, or have spread to other parts of the body.
A gastrointestinal stromal tumour (GIST) is a rare type of soft tissue sarcoma that is found in the , most often in the wall of the stomach.
If a GIST can’t be removed with surgery, or has spread to other parts of the body, you may have a drug called imatinib.
Imatinib is a type of biological therapy called a tyrosine kinase inhibitor or TKI. It stops signals that cancer cells use to divide and grow.
Masitinib is another TKI that researchers think might work better as the first drug treatment for gastrointestinal stromal tumours. The aims of this trial are to
You may be able to enter this trial if you
You cannot enter this trial if you
This phase 3 trial will recruit more than 450 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
In earlier trials, some people taking masitinib, had a skin rash or puffiness in their face, eyelids or ankles. To try to prevent these side effects, people in group 1 also take an drug called cetirizine. You start it at the same time as the masitinib tablets and take it for 2 months.
The trial team will give you a diary card to keep at home. In this, you write down when you take your tablets and whether you need to take any other medication.
The trial team will also ask you to fill out a questionnaire before you start treatment, every 3 months during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
As long as you don’t have bad side effects, you can carry on taking masitinib or imatinib for as long as it is helping you.
If you are taking masitinib and have bad side effects, or a scan shows your tumour has started to get worse, you can start taking imatinib instead.
If you are taking imatinib and your tumour starts to get worse, the trial team will talk to you about switching to a different type of treatment. But you can’t switch from imatinib to masitinib in this trial.
You see the trial team and have some tests before you start treatment. The tests include
If you haven’t had one in the last 4 weeks, you also have a CT scan of your tummy () and the area between your hip bones (
).
You see the trial team every 4 weeks for the first 3 months, and then once every 3 months for the rest of the time you are having treatment. You have a physical examination each time.
You have blood tests
You have a heart trace every 6 months and a CT scan every 3 months during treatment.
When you finish treatment, you see the trial team again and have a physical examination, blood tests, a heart trace and a CT scan. Your doctor may ask to take a of your tumour. But you don’t have to agree to this if you don’t want to.
As masitinib is a new drug, there may be side effects we don’t know about yet. In earlier trials, the most common side effects were
You take an antihistamine tablet called cetirizine to try to prevent some of these side effects. Cetirizine can make you feel drowsy, so you should take it before you go to bed.
Taking either masitinib or imatinib increases your risk of infection due to a drop in the number of white blood cells.
We have more information about the other side effects of imatinib in our cancer drugs section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Michael Leahy
AB Science
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.