
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 2 drugs called masitinib and sunitinib for a rare type of soft tissue sarcoma called gastrointestinal stromal tumour or GIST. The people taking part have a GIST that has spread to another part of their body or can’t be removed with surgery.
If a GIST can’t be removed with surgery, or has spread to another part of your body, you may have a drug called imatinib. It is a type of biological therapy called a tyrosine kinase inhibitor or TKI.
Imatinib stops signals that cancer cells use to divide and grow. But GISTs may get worse despite having imatinib. Researchers are looking for new treatments to help people in this situation.
In this trial they are looking at 2 other TKI drugs called sunitinib and masitinib. The aims of the trial are to compare the 2 drugs to
You may be able to join this trial if all of the following apply. You
You cannot join this trial if any of these apply. You
This phase 3 trial will recruit more than 300 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.
As long as you don’t have bad side effects, you can carry on having the trial treatment for as long as it is helping you.
The trial team will ask you to fill out a questionnaire before you start treatment, every 8 weeks for the first 6 months of treatment, every 3 months for the rest of the time you are having treatment and when you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
They will also give you a diary card to keep at home. In this, you write down when you take your tablets and whether you take any other medication.
You see the trial team and have some tests before you start treatment. The tests include
The trial team need to get a sample of your sarcoma to look for changes to certain genes. They should be able to get a sample from the tissue that was removed when you had surgery or a in the past. So it is unlikely that you will need to have a new biopsy.
You see the trial team once a month for the first 4 months, once more 2 months later and then once every 3 months after that.
You have a physical examination and blood tests at each visit. You have a CT scan every 8 weeks for the first 6 months of treatment and then every 3 months after that. You have an ECG every 3 months during the first year of treatment, every 6 months in the 2nd year and then once every 3 months after that.
When you finish treatment, the trial team may ask you to have another biopsy. But you don’t have to agree to this if you don’t want to. You can still take part in the trial.
If you are in the group taking masitinib and stop the treatment, you may start having sunitinib or another type of treatment. If you do this, the trial team will phone you every 3 months to see how you are. And if you start taking sunitinib at this point, they will ask you to have a more CT scans. These will be about every 3 months.
As masitinib is a new drug, there may be side effects we don’t know about yet. In trials so far, the most common side effects have been
The most common side effects of sunitinib include
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
Experimental Cancer Medicine Centre (ECMC)
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.