A trial of posaconazole tablets for people at high risk of fungal infections

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

Cancer type:

Myelodysplastic syndrome (MDS)




Phase 1

This trial is looking at a drug called posaconazole for people who are at high risk of getting a fungal infection during treatment for acute myeloid leukaemia or myelodysplastic syndromes (MDS).

A common side effect of treatment for leukaemia or MDS is a drop in the number of white blood cells. This is called neutropenia (pronounced new-troh-pee-nee-ah) and puts you at high risk of infection. One type of infection you may get is a fungal infection.

Posaconazole is a drug that prevents and treats fungal infections. It is already available as a liquid that you swallow. But you have to take the liquid with food that is high in fat, or with a dietary supplement. People having chemotherapy may find it difficult to eat, so in this trial researchers are testing a tablet form of the drug, which you can take without food.

They will look at how the body absorbs, breaks down and gets rid of the posaconazole tablets. You may hear this called pharmacokinetics. They also want to learn more about the side effects.

Who can enter

You can enter this trial if you

  • Are having induction chemotherapy for acute myeloid leukaemia or myelodysplastic syndromes, or have had a stem cell transplant using donor cells
  • Are able to swallow tablets
  • Are at least 18 years old and weigh at least 34kg
  • Are willing to use a reliable method of contraception during the trial if there is any chance you or your partner could become pregnant

You cannot enter this trial if

  • You have a fungal infection or have had treatment for a fungal infection in the last month (you can take part if you have taken medicine to prevent a fungal infection)
  • You have graft versus host disease affecting your stomach unless it is very mild
  • Your liver is not working very well or you have certain changes to your heart rhythm (the trial team can advise you about this)
  • You have taken posaconazole in the last 10 days
  • You have had a reaction to any drug that is similar to posaconazole
  • You have any other medical condition (apart from leukaemia or MDS) that could affect you taking part
  • You are pregnant or breastfeeding

Trial design

If you agree to take part in this study, you have the trial treatment during your treatment for leukaemia or MDS.

You take posaconazole tablets every day for up to 4 weeks. You take the tablets twice on the 1st day of treatment and then once a day after that. You have to take the tablets about the same time each day. But on the days you see the trial team, you must not take the tablets until they have taken a blood sample.

During treatment, you fill in a diary to record exactly when you take the tablets and any side effects you have.

Hospital visits

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

  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Blood tests

You will see the trial team and have blood tests

  • On each of the first 3 days you take posaconazole
  • Twice in the following week
  • Then once a week for the next 2 weeks

You have a physical examination each time and the trial doctor will look for any signs of a fungal infection. At some visits, you also have an ECG.

After you finish taking posaconazole, you see the trial team again a week to 10 days later, and once more about a month after that.

Side effects

As the tablets are a new form of posaconazole, there may be some side effects we don’t know about yet. The possible side effects of posaconazole we know about include

Posaconazole may cause changes to the way your liver works or changes to your heart rhythm. The trial team will take blood samples to monitor how your liver is working and you have ECGs to monitor any effect on your heart.

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 Michael Potter

Supported by

Experimental Cancer Medicine Centre (ECMC)
Schering Plough Research Institute

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 8034

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

Charlie took part in a trial to try new treatments

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“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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