
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called E7080 for melanoma that has spread to , surrounding tissue or other parts of the body (stage 3 or 4 melanoma). It is for people who have melanoma that has got worse despite having other treatment.
Cancer cells release chemicals that encourage new blood vessels to grow around them. The cancer needs a blood supply so that it can grow and spread. E7080 stops this by blocking a growth factor called VEGF.
Researchers want to see if E7080 helps people with melanoma that has got worse despite other treatment and can’t be removed with surgery. The aims of this trial are to
You may be able to enter this trial if you
or
As well as the above, you must
You cannot enter this trial if you
This phase 2 trial will recruit up to 178 people in a number of different countries. Everybody taking part will have E7080.
You take E7080 capsules once a day. The trial team will give you more information about how many capsules to take and you keep a diary at home to note down when you take them.
As long as you don’t have bad side effects, you can carry on having E7080 for as long as it helps you.
When you join the trial, the researchers need to get a sample of your melanoma cells to test for a change (mutation) to a gene called BRAF. About half of all melanomas diagnosed have a BRAF gene mutation. The researchers want to find out if melanoma cells with this gene change respond differently to E7080.
The trial team will try to get a sample of tissue that was removed in the past when you had surgery or a . But if there is not a sample available, they will ask you to have a biopsy.
They will look for substances called in the tissue sample and in blood samples they take during treatment. These may help to show how your melanoma is responding to E7080. They will also study your DNA to see how your genes affect the way your body handles the drug.
You see the trial team and have some tests before you start treatment. The tests include
A member of the trial team will take pictures of any melanoma on your skin.
During treatment, you go to hospital once every 2 weeks. You have blood tests at most visits. At 3 hospital visits you have extra blood tests 2 and 12 hours after taking the E7080 capsules. The researchers will use these to learn more about what happens to the drug in your body ().
Every 8 weeks, you have a CT or MRI scan and a member of the trial team will take photographs of any melanoma on your skin. You have a bone scan every 6 weeks. You have an echocardiogram or MUGA scan every 4 months.
When you finish treatment, you see the trial team again within the next month. You have a physical examination, more blood tests, a urine test, an ECG and an echocardiogram or MUGA scan. You have a CT or MRI scan if you haven’t had one in the last 4 weeks, and you may have more photographs taken of your skin.
After you finish treatment, a member of the trial team will contact you by phone. To start with this will be every 4 to 8 weeks, then every 12 weeks up to 2 years after you finish treatment. After that, they will contact you
If you stop having E7080 for any reason other than your melanoma getting worse, the trial team will ask you to have follow up appointments and scans every 8 weeks until either you start another treatment, or your melanoma starts to get worse.
As E7080 is a new drug, there may be side effects we don’t know about yet. From trials of treatments that work in a similar way, and from studying this drug in different diseases, we know that possible side effects may include
The trial team will talk to you about other possible side effects before you agree to join the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Jeff Evans
Eisai
Experimental Cancer Medicine Centre (ECMC)
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”