A trial of APD403 to prevent sickness caused by chemotherapy

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

Cancer type:

All cancer types

Status:

Closed

Phase:

Phase 2

This trial is looking at a drug called APD403 to see if it prevents sickness caused by certain chemotherapy drugs.

Doctors often use chemotherapy to treat cancer. Some chemotherapy drugs can make you feel sick or be sick. It can happen on the day you have chemotherapy or during the next few days.

Doctors prescribe anti sickness drugs that you have just before chemotherapy and for the next few days. But even with anti sickness drugs, some people do feel sick after having chemotherapy, so researchers are looking for new drugs to prevent chemotherapy related sickness. In this trial, they are looking at a drug called APD403.

The aim of the trial is to see how good different doses of APD403 are at stopping sickness during the 5 days after chemotherapy.

Who can enter

You may be able to enter this trial if you have cancer and are going to have chemotherapy for the first time.

If you are male, your chemotherapy must include a high dose of a drug called cisplatin
If you are female, your chemotherapy must include high dose cisplatin or a combination of the drugs cyclophosphamide and either epirubicin or doxorubicin

And as well as the above, you must

Be able to care for yourself, even if you need help from time to time (a Karnofsky score of at least 60)
Have satisfactory blood test results
Be at least 18 years old
Be willing to use reliable contraception during the trial and for up to a month afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have had chemotherapy before
Are going to have any other chemotherapy drugs (apart from those listed above) if they have a moderate to high risk of making you feel sick (this includes paclitaxel or docetaxel)
Are going to have radiotherapy to the area between your hips (your pelvis ) either in the 48 hours before you have chemotherapy, or within 5 days afterwards
Have sickness in the 24 hours before you have your chemotherapy
Have a cancer that is affected by a hormone called prolactin, such as a tumour in your pituitary gland (your doctor can advise you about this)
Have taken a drug called amisulpride for any reason in the last 2 weeks
Are known to be allergic to the drugs amisulpride, ondansetron, fosaprepitant or dexamethasone, or any of the ingredients of APD403
Have a condition that affects your balance (a vestibular disorder)
Take regular anti sickness drugs - this includes steroids , but a steroid inhaler is allowed if you started using it more than a month ago
Take a drug called levodopa
Take medication that can affect your heart rhythm or have an irregular heart beat that causes symptoms (the trial team can advise you about this)
Take drugs called benzodiazepines, unless you have been on a stable dose for at least a month (your doctor can advise you about this)
Have had problems with alcohol that the trial doctor thinks a cause for concern
Are pregnant or breastfeeding
Have taken part in a trial of another experimental treatment in the last 4 weeks
Have any other medical condition that the trial team think could affect your taking part

Trial design

This phase 2 trial will recruit more than 300 people in a number of different countries.

The trial is randomised trial. The people taking part are put into 1 of 5 treatment groups by a 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.

Everybody taking part has anti sickness drugs through a drip into a vein before having chemotherapy. Whichever group you are in, this will include an anti sickness drug called ondansetron.

The other drug (or drugs) you have through the drip depends on the group you are in. You may have a steroid drug called dexamethasone, another anti sickness drug called fosaprepitant, or the trial drug which is called APD403. For people in 4 of the groups, one of the drugs is a dummy drug (a placebo Open a glossary item ). It will only be salt water (saline).

You also take anti sickness tablets and capsules by mouth for the next 3 days. The type of tablets and capsules you have depends on which group you are in. The different combinations of drugs are described below

People in group A have ondansetron, dexamethasone and fosaprepitant through the drip. They take dexamethasone tablets and dummy capsules for the next 3 days.

People in group B have ondansetron, APD403 and a dummy drug through the drip. They take dummy tablets and dummy capsules for the next 3 days.

People in group C have ondansetron, APD403 and a dummy drug through the drip. They take dummy tablets and low dose APD403 capsules for the next 3 days.

People in group D have ondansetron, APD403 and a dummy drug through the drip. They take dummy tablets and a higher dose of APD403 capsules for the next 3 days.

People in group E have ondansetron, APD403 and a dummy drug through the drip. They take dummy tablets and an even higher dose of APD403 capsules for the next 3 days.

The trial team will give you a diary card to keep. You fill it in each day on the 3 days after your chemotherapy, writing down if you’ve been sick or felt sick. If you do feel sick at any time, you score it out of 100 where 0 is not feeling sick at all and 100 is the worst possible feeling of sickness.

If you are sick (or feel sick), you can take other anti sickness drugs that the trial doctor gives you. You should only take these if you are sick (or feel sick). You must write on the diary card when you take any of these extra tablets.

Hospital visits

Before you start treatment, you see the trial team and have some tests including

Physical examination
Blood tests
Heart trace (ECG )

During the hour before you start your chemotherapy, you have anti sickness drugs through a drip into a vein. You then have another ECG before you start your chemotherapy.

A week after your chemotherapy, you go back to hospital to see the trial team. At this visit, you have a blood test and another ECG.

Side effects

The active ingredient of APD403 is amisulpride. It is a drug that has been used for many years as a treatment for schizophrenia. All the doses being looked at in this trial are lower than the dose used to treat schizophrenia.

The most common side effects of higher doses of amisulpride include

Involuntary movements such as twitching
Problems sleeping
Anxiety and agitation
Weight gain
Headache

Occasional side effects include sleepiness, constipation, dry mouth and sickness. But the researchers think all these side effects are very unlikely at the low doses being used in this trial.