A trial of liposomal eribulin for advanced solid tumours

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

Cancer type:

All cancer types

Status:

Closed

Phase:

Phase 1

This trial is looking at a new form of a drug called eribulin for solid tumours. A solid tumour Open a glossary item is any cancer apart from leukaemia or lymphoma .

Researchers are looking for new ways to treat solid tumours that can’t be removed with surgery or have got worse despite other treatment. In this trial, they are looking at a new form of a drug called eribulin.

Eribulin is a type of chemotherapy that doctors already use to treat some types of cancer. In this new form, the drug has been wrapped up in a fatty covering called a liposome. This helps the drug to stay in the bloodstream longer, so that more of the drug may reach cancer cells.

The aims of the trial are to

Find the highest dose of liposomal eribulin you can safely have
Learn more about what happens to the drug in your body
See if it helps people with an advanced solid tumour

Who can enter

You may be able to enter this trial if you

Have a solid tumour that cannot be removed with surgery or has got worse despite having other treatment and there are no other standard treatments available
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 reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have had major surgery or any other cancer treatment in the last 3 weeks (6 weeks if you had chemotherapy drugs called nitrosoureas or mitomycin C)
Have had an experimental drug as part of another clinical trial in the last month
Have not recovered from the side effects of any other treatment (apart from hair loss) unless they are mild
Have damage to the nerves in your hands or feet (peripheral neuropathy) unless it is very mild
Have already had eribulin
Have had radiotherapy that included more than about a third of your bone marrow - your doctor can advise you about this
Have cancer that has spread to your brain unless this has been successfully treated, you haven’t taken steroids in the last 4 weeks and symptoms haven’t got worse
Have cancer that has spread throughout your central nervous system (meningeal carcinomatosis)
Have certain heart problems - the trial team can advise you about this
Have any other condition that needs treatment or that the trial doctors think could affect you taking part
Are known to have HIV, hepatitis B or hepatitis C infection
Have had problems with drugs or alcohol in the last 2 years
Are known to be very sensitive to the trial drug or any of its ingredients
Are due to have surgery in the near future
Are very overweight and have a body mass index (BMI ) higher than 35
Have cancer that is causing a build up of fluid in your tummy (ascites ) or in your lungs (pleural effusion) that is causing symptoms or has not responded well to treatment – the trial team can advise you about this
Are pregnant or breastfeeding

Trial design

This phase 1 trial will recruit up to 96 people. The trial is in 2 parts.

In the 1st part of the trial, researchers are trying to find the highest safe dose of liposomal eribulin and the best way to give it. The first patients taking part will have a very low dose of liposomal eribulin. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.

Everybody taking part has eribulin through a drip into a vein. It takes at least an hour each time. There are different ways of having the drug. Depending on when you join the trial, you have it either

Once every 3 weeks
Once every 4 weeks
Once every 2 weeks

In the 2nd part of the trial, researchers want to learn more about the side effects of liposomal eribulin. Everybody joining this part of the trial will have the highest safe dose that was found in part 1. They will have one of the treatment plans above. The treatment plans that the researchers will look at in this part of the study will also depend on the results from part 1.

As long as they don’t have bad side effects, people joining either part of the trial can carry on having liposomal eribulin for as long as it helps them.

Hospital visits

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

Physical examination
Heart trace (ECG )
Blood tests and urine tests
CT scan or MRI scan

You may also need to have a bone scan.

The trial team will ask your permission to get a sample of tissue that was removed when your cancer was first diagnosed or when you had surgery.

The first time you have liposomal eribulin, you stay in hospital overnight. If you join the 1st part of the trial, you will be asked to wear a small portable machine that records your heartbeat. This is called a Holter monitor Open a glossary item . You wear it for 24 hours before you have your first dose of eribulin and for at least 24 hours afterwards.

The number of hospital visits you have during treatment will depend on which treatment plan you have. Everybody has regular physical examinations, blood tests and urine tests. You have a CT or MRI scan every 6 or 8 weeks (depending on your treatment plan).

When you finish treatment, you see the trial team a month later and have a physical examination, heart trace, blood tests and urine tests.

If you stop the trial treatment for any reason other than your cancer getting worse, you will be asked to carry on having a CT or MRI scan every 8 or 9 weeks (depending on the treatment plan you’ve been having) until your cancer starts getting worse or you start having another treatment.

Side effects

As liposomal eribulin is a new form of the drug, there may be side effects we don’t know about yet. The most common side effects of the standard form of eribulin include

A drop in the number of red and white blood cells causing an increased risk of infection, tiredness and breathlessness
Numbness and tingling in your hands and feet (peripheral neuropathy)
Feeling or being sick
Diarrhoea or constipation
Headache
Pain in your back, joints, muscles or bones
Hair loss
Loss of appetite