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)

Status:

Closed

Phase:

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 )
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

Feeling or being sick
High temperature (fever)
Diarrhoea
Headache
Cough

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.