A trial looking at cabozantinib for primary liver cancer that has got worse despite having sorafenib

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

Cancer type:

Liver cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at cabozantinib for people with the most common type of primary liver cancer called hepatocellular carcinoma or HCC. It is for people who have already had the cancer drug sorafenib. Cabozantinib (pronounced cab-oh-zan-tin-ib) is also called XL184.

More about this trial

Doctors often use sorafenib to treat primary liver cancer, but sometimes the cancer can come back. Researchers are looking for new treatments to help people in this situation.

Cabozantinib is a new biological treatment  called a tyrosine kinase inhibitor or TKI. It stops signals that cancer cells use to divide and grow.

In this trial, researchers will compare cabozantinib with a dummy drug (a placebo Open a glossary item). The aims of the trial are to

  • Find out if cabozantinib can help people with advanced primary liver cancer
  • 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 type of liver cancer called hepatocellular carcinoma
  • Are not able to have treatment to cure your cancer
  • Have already had the drug sorafenib but the cancer has got worse
  • Have recovered from the side effects of any other cancer treatment unless they are very mild
  • Have satisfactory blood and urine test results
  • Have normal liver function (Child-Pugh score A)
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
  • Are willing to use reliable contraception while taking part in the trial, and for 4 months afterwards, if there is a chance that you or your partner could become pregnant
  • Are at least 18 years old

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

  • Have any other type of liver cancer
  • Have had more than 2 treatments that reach your whole body (systemic treatments Open a glossary item) for advanced liver cancer
  • Have had radiotherapy in the 4 weeks before starting the trial
  • Have had a radioactive treatment called Yttrium or radioactive iodine in the 6 weeks before starting the trial
  • Have had any other whole body anti cancer treatment in the 2 weeks before starting the trial
  • Have had major surgery in the last 2 months or have a wound from surgery that is not healed
  • Have had cabozantinib before
  • Are taking certain drugs that thin your blood (the trial team can advise you about this)
  • Have had a heart attack or stroke in the 6 months before starting the trial or have certain other heart or lung problems (the trial team can advise you about this)
  • Have high blood pressure that cannot be controlled with medication
  • Have cancer that has spread to your brain or tissues covering your brain unless this has been treated with surgery or radiotherapy, has not got worse in the 3 months before starting the trial, and you are no longer taking steroids
  • Have cancer that has grown into a major blood vessel
  • Have had a hole, a blockage or an abnormal opening called a fistula Open a glossary item in your gut, or a collection of pus (an abscess) in your tummy (your abdomen) in the 6 months before starting the trial
  • Have certain other problems with your digestive system Open a glossary item (the trial team can advise you about this)
  • Have had blood in your urine, coughed or vomited blood in the 3 months before starting the trial, or you are at an increased risk of bleeding
  • Have a build up of fluid in your tummy (abdomen) called ascites
  • Have another serious medical condition that the trial team think could affect you taking part
  • Are known to be allergic or sensitive to anything in cabozantinib (your doctors can advise you about this)
  • Have had any other cancer in the 2 years before starting the trial, unless it was a very early stage and has been successfully treated (the trial team can advise you about this)
  • Are pregnant or breastfeeding
  • Are unable to swallow tablets

Trial design

This international trial aims to recruit 760 people with primary liver cancer (hepatocellular carcinoma).  It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

If you are in group 1, you will have cabozantinib. If you are in group 2, you will have a dummy tablet (a placebo Open a glossary item). There will be twice as many people in the group having cabozantinib as in the group having the dummy drug.

 

You have cabozantinib or the dummy tablet every day for as long as the treatment helps you.

The trial team will ask you to fill out a questionnaire before you start treatment, every 4 weeks for 6 months then every 8 weeks for the rest of your treatment and 8 weeks after finishing treatment. The questionnaire will ask about side effects and how you’ve been feeling.  This is called a quality of life study.

Hospital visits

Before you start your treatment, a doctor will examine you and you may have various tests. These tests include

You will have your first dose of tablets in hospital. You then take the rest of the doses at home once a day, preferably at bedtime.

To begin with you will need to go to hospital every 2 weeks. The doctor will examine you and may repeat some of the tests you had before you started treatment. After 9 weeks you go to hospital once a month.

You will have a CT scan or MRI scan every 2 months. You will have a bone scan every 4 months if the scan you had before starting treatment showed cancer in your bones.

When you finish treatment, you see trial team once more about a month later. It is likely they will ask you to have another scan about 8 weeks after you finish treatment.

Side effects

Cabozantinib is a new drug and there may be some side effects we don’t know about yet. The most common side effects include

People taking cabozantinib have had other less common but serious side effects. The trial team will discuss these with you.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Prof Tim Meyer

Supported by

Exelixis
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11196

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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