A trial looking at a drug called E7080 for melanoma

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

Cancer type:

Melanoma

Skin cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at a new drug called E7080 for melanoma that has spread to lymph glands Open a glossary item , 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

See if E7080 shrinks melanoma, and if so how long the effect lasts
Learn more about how the drug works and what happens to it in your body

Who can enter

You may be able to enter this trial if you

Have melanoma that does not have a particular change to a gene called BRAF (the trial team will test for this) and your melanoma has got worse despite having up to 2 other drug treatments that reach your whole body (systemic treatments ), but you have not had a treatment that targets BRAF

Have melanoma that does have the change to the BRAF gene and your melanoma has got worse despite having a treatment that targets this change, as well as up to 2 other systemic treatments

As well as the above, you must

Have melanoma that has spread from where it started (stage 3 or 4) and can’t be removed with surgery
Have at least 1 area of melanoma that can be measured on a scan or photograph
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use 2 reliable forms of contraception during the trial and for a month after stopping E7080 if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have melanoma that started in your eye
Have melanoma that has spread to your brain, unless this has been completely removed with surgery at least a month ago and a scan shows it has not come back, or you had stereotactic radiotherapy at least a month ago and a scan shows it is not getting any worse – as well as this, you must not have taken steroids for at least a month and not have any symptoms
Have had more than 2 drug treatments for stage 3 or 4 melanoma, or if your cancer has the change in the BRAF gene, you have had more than 2 drug treatments as well as the treatment targeting the BRAF gene change
Have had major surgery in the last 3 weeks
Have had any other cancer treatment in the last 4 weeks or have not recovered from side effects of earlier treatment (if you have been having treatment that targets the BRAF gene change and your melanoma has got worse despite this, you may have had treatment more recently, but it must have finished at least 14 days before your first dose of the trial drug)
Have high blood pressure that cannot be controlled with medication
Have large amounts of protein in your urine (you will have urine tests to check for this)
Cannot swallow or absorb tablets for some reason
Have had a heart attack or stroke in the last 6 months, or have certain heart problems – the trial team can advise you about this
Have problems with bleeding or blood clotting which means you need to take medication to thin your blood (anticoagulants)
Have coughed up more than about half a teaspoon of blood in the last 3 weeks
Have had any other type of cancer in the last 2 years apart from non melanoma skin cancer or carcinoma in situ of the cervix
Have any other condition that the trial team think could affect you taking part
Are pregnant or breastfeeding

Trial design

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 biopsy Open a glossary item . But if there is not a sample available, they will ask you to have a biopsy.

They will look for substances called biomarkers Open a glossary item 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.

Hospital visits

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

Physical examination
Heart trace (ECG )
Heart ultrasound (echocardiogram ) or MUGA scan
Blood tests and urine tests
CT scan
MRI scan
Bone scan

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 (pharmacokinetics Open a glossary item ).

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

Every 6 months for the next 2 years
Once a year after that

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.

Side effects

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

High blood pressure
Protein in the urine
Tiredness (fatigue)
Diarrhoea
Feeling or being sick
Voice changes
Loss of appetite and weight loss
Headache
Constipation
Tummy pain
Sore mouth (stomatitis)
Rash
Joint pain
A drop in blood cells causing an increased risk of bruising, bleeding and infection
Redness, tingling and sore hands and feet (hand foot syndrome)