A trial looking at panobinostat for advanced cancer to see how the liver affects what happens to it in the body

Cancer type:

All cancer types

Status:

Results

Phase:

Phase 1

This trial aimed find out more about how the body absorbs and gets rid of a drug called panobinostat. It was for people with a solid tumour that had spread (advanced cancer). A solid tumour Open a glossary item is any type of cancer apart from leukaemia Open a glossary item or lymphoma Open a glossary item.

More about this trial

Panobinostat is a drug that blocks certain proteins (enzymes Open a glossary item). Cells need these enzymes to grow and divide. Blocking them may stop cancer growing.

One of the important jobs that the liver does is to get rid of drugs from the body. But if you have advanced cancer Open a glossary item, your liver may not be working very well. Doctors can measure how well the liver is working by doing blood tests called liver function tests.

Studying what happens to a drug in the body is called pharmacokinetics Open a glossary item. This includes looking at how long the drug stays in the body and how the liver gets rid of it.

The aims of this trial were to

  • Find out more about what happens to panobinostat in people with different levels of liver function
  • Learn more about the side effects of the drug

Summary of results

The study team found that it was safe to give panobinostat to people with mild to moderate liver problems.

25 people took part in this study. Of those, 15 had liver problems.

The researchers took blood samples from everyone before the first dose of panobinostat then every few hours after having the drug and a final sample after 96 hours.

The researchers looked at how long the drug stays in the body and how the liver gets rid of it. They found that people with mild to moderate liver problems had slightly higher levels of the drug in their blood samples than people who didn’t have liver problems. But having mild to moderate liver problems didn’t affect how the body absorbed the drug.

The main side effects were

  • Feeling or being sick
  • Tiredness (fatigue)
  • Loss of appetite
  • Bleeding problems
  • Diarrhoea

These didn’t seem to be much worse in people with liver problems.

The trial team concluded that people with mild to moderate liver problems can safely have the same starting dose of panobinostat as people who don’t have liver problems as long as doctors keep a close eye on side effects and change the dose as necessary.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

Dr Sally Clive

Supported by

Experimental Cancer Medicine Centre (ECMC)
Novartis

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 6269

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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