
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at tefinostat for the most common type of liver cancer called hepatocellular carcinoma (HCC). The trial is supported by Cancer Research UK.
Tefinostat is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
A small number of people have had tefinostat for or
, but this is the first time it is being tested in people with liver cancer.
The aims of the trial are to
You may be able to enter this trial if
If you have scarring of the liver (cirrhosis) caused by alcohol, you may be able to take part in the trial. The doctors will discuss this with you. If you have hepatitis you may also be able to take part as long as it is well controlled by anti viral treatment.
You cannot enter this trial if you
The trial will recruit between 54 and 69 people across the UK.
The first patients taking part will have a low dose of tefinostat. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until the researchers find the best dose to give. This is called a dose escalation study. Once they have found the highest safe dose, another 40 people in the trial will have that dose.
Tefinostat comes as capsules that you swallow. You take them every day after eating. The trial team will explain how many capsules to take and how often to take them. You keep a diary at home to note down when you take the capsules.
As long as you don’t have any bad side effects, you can carry on having tefinostat for as long as it helps you.
You see the trial team and have some tests before you start treatment. The tests include
You go to hospital once a week for the first 4 weeks of treatment and then once every 2 weeks after that. You have a physical examination and blood tests each time.
About a month after starting treatment, the researchers will ask you to have another liver biopsy. You don’t have to have this if you don’t want to. You can still take part in the trial.
During treatment, you have a CT or MRI scan and an ECG every 12 weeks.
When you finish treatment, you see the trial team again and have a CT or MRI scan, an ECG and more blood tests and urine tests. You then see the trial team every 2 months for up to a year.
As tefinostat is a new drug, there may be side effects we don’t know about yet. Only a small number of people have had tefinostat. The side effects they had included
The side effects of having a liver biopsy include pain and slight swelling or bruising. There is a risk of bleeding after a liver biopsy, but this is rare.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr David Propper
Cancer Research UK
Chroma Therapeutics
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Queen Mary University of London
This is Cancer Research UK trial number CRUKD/12/011.
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.