A trial looking at fosaprepitant for children and young people to prevent sickness after chemotherapy

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

Cancer type:

Children's cancers

Status:

Closed

Phase:

Phase 2

This trial is looking at fosaprepitant [FOS-a-PRE-pi-tant] to help stop sickness in children and young people who are having chemotherapy. This drug is also known as MK 517 or Ivemend.

This trial is for children and young people under the age of 12. We use the term ’you’ in this summary, but if you are a parent, we are referring to your child.

More about this trial

Chemotherapy can make you feel sick or be sick. Doctors have a number of anti sickness drugs to help control or prevent this. These work, but researchers are always looking for better treatments.

Fosaprepitant is an anti sickness drug that is approved for use in adults. Researchers want to find out if it can help prevent sickness in children and young people who are having chemotherapy.

The aims of this trial are to find out

How safe fosaprepitant is for children and young people
What happens to fosaprepitant in their body

Who can enter

You may be able to enter this trial if you

Are to have chemotherapy that can cause moderate to severe sickness or are having chemotherapy that had previously made you sick
Are to have an anti sickness drug called ondansetron
Have a central line in place
Have satisfactory blood tests results
Are well enough to take part – if you are over 10 years old this means that you can mostly care for yourself (Karnofsky score of 60 or more), for children 10 years old or younger it means that you are up and around even if not playing as energetically as usual (Lansky score of 60 or more)
Are willing to use a barrier contraception, such as a condom or diaphragm, during treatment and for 3 months afterwards if you are sexually active
Are up to 12 years old

You cannot enter this trial if you

Are very underweight (the trial team will confirm this)
Have been sick the day before starting your chemotherapy
Are to have a stem cell transplant as part of your treatment
Have had radiotherapy to your tummy (abdomen ) or the area between your hip bones (your pelvis ) in the week before starting chemotherapy
Are likely to have radiotherapy to your abdomen or pelvis during chemotherapy
Have cancer that has spread to your brain or spinal cord and is making you feel or be sick. If the cancer spread isn’t causing any symptoms you may be able to take part
Have an infection
Have a heart problem
Have any other medical problem that isn’t controlled or may affect you taking part in this trial
Are taking a drug called warfarin
Are taking drugs that affect the CYP3A4 enzyme
Have started a drug that is a benzodiazepine in the past 2 days, apart from a single daily dose of triazolam, temazepam or midazolam – your doctor can confirm this
Have started taking a strong painkilling drug (an opioid ) in the past 2 days – your doctor can confirm this
Have started taking steroids in the last 3 days or are going to have steroids as part of your chemotherapy treatment – if you were having steroids as an ongoing treatment before the last 3 days and the dose was 10 mg or less you may be able to take part
Have had aprepitant, fosaprepitant or an experimental drug as part of a clinical trial in the past month
Are allergic to aprepitant, fosaprepitant, ondansetron or similar drugs

Trial design

This is an international phase 2 trial. The trial team need 60 children and young people from different countries around the world to join.

Everyone taking part will have fosaprepitant.

You have the fosaprepitant and ondansetron as an injection into your central line. You have them before your chemotherapy.

You have a diary to record any medication you take and how many times you feel sick or are sick. You fill this in for 5 days after treatment.

For some of the people taking part, the researchers will ask to take some blood samples. This is to find out how much fosaprepitant the body absorbs, what happens to it in the body and how the body gets rid of it.

The researchers will ask to take 2 swabs form the inside of your mouth. They will use these to learn more about cancer and its treatment. You don’t have to agree to this if you don’t want. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

A physical examination
Blood tests
Heart trace (ECG )
Urine test

In the 1st part you see the doctor 5 times in 45 days. You may also need to stay in hospital for 1 or 2 nights. Your doctor will talk to you about this.

Side effects

The most common side effects of fosaprepitant include

Hiccups
Feeling tired
Headache
Loss of appetite
Indigestion
Burping
Constipation
Changes to the way your liver works
Allergic reaction with signs such as a rash, itching, redness of the face or skin and difficulty breathing or swallowing

The most common side effects of ondansetron are