A trial of masitinib and sunitinib for gastrointestinal stromal tumours that have got worse despite having imatinib

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Sarcoma

Soft tissue sarcoma

Status:

Closed

Phase:

Phase 3

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

See which is better for GISTs that have got worse despite having imatinib
Learn more about the side effects

Who can enter

You may be able to join this trial if all of the following apply. You

Have a gastrointestinal stromal tumour (GIST) that has spread to another part of your body or can’t be removed with surgery, and has got worse while having imatinib
Have a GIST with large amounts of a protein called CD117 (your doctor can advise you about this)
Have at least 1 area of cancer that can be seen and measured on a scan
Have stopped taking imatinib and recovered from any side effects
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant

You cannot join this trial if any of these apply. You

Have sarcoma that has spread to your brain or spinal cord (your central nervous system)
Have had any other type of cancer in the last 5 years apart from carcinoma in situ of the cervix or basal cell skin cancer
Have had another experimental drug in the last 4 weeks
Had higher than the standard dose of imatinib (your doctor can advise you about this)
Weren’t able to take imatinib
Have already had sunitinib or a similar type of drug (apart from imatinib)
Are known to be very sensitive to either masitinib or sunitinib, or to anything they contain
Have high blood pressure that can’t be controlled with medication, or have certain heart problems (the trial team can advise you about this)
Have had problems with drug or alcohol addiction, or drink large amounts of alcohol, or have a mental health problem, and the trial team think that any of these things could affect your taking part
Are pregnant or breastfeeding

Trial design

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.

Group 1 have masitinib tablets twice a day, every day
Group 2 have sunitinib tablets once a day for 4 out of every 6 weeks

trial diagram

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.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

Physical examination
Blood tests
Heart trace (ECG )
CT scan (if you haven’t had one in the last 4 weeks)

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 biopsy Open a glossary item 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.

Side effects

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

Feeling or being sick
Diarrhoea
A build up of fluid in the body (oedema) causing swelling, especially of the eyelids, arms and legs
Skin rash
A drop in the number of white blood cells causing an increased risk of infection

The most common side effects of sunitinib include

Tiredness (fatigue) and weakness
Feeling or being sick
Diarrhoea
Skin rash
Changes to the colour of your hair or skin
A drop in the number of white blood cells causing an increased risk of infection
High blood pressure
Loss of appetite
Sore mouth
Taste changes
Swollen legs
Constipation
Aching muscles
Dehydration
Urine infections