
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is in 2 parts, the first part was for people with a solid tumour, the second part is for women with ovarian cancer. Women need to have one of the following:
Also, they should have a serous type cancer that is high grade. High grade means that the cancer is more likely to grow quickly.
The first part of the trial has closed. This information is about the second part.
ONX-0801 is a chemotherapy drug called a thymidylate synthase inhibitor. It works by targeting cancer cells and stopping the action of a protein called thymidylate synthase.
Proteins such as thymidylate synthase can start behaving abnormally when cancer is present, helping the cancer cells to grow.
ONX-0801 targets cancer cells that make too much of another protein called alpha folate receptor which is found on the surface of the cell.
ONX-0801 enters the cell through the alpha folate receptor and switches off or stops thymidylate synthase from working. Blocking the action of thymidylate synthase may help to stop cancer growing.
Researchers think that this drug may be useful in certain cancer types that make a lot of alpha folate receptor, such as ovarian cancer.
The aims of this trial are to:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if you have one of the following.
In addition to the above, you have all of the following
You cannot join this trial if any of these apply. You
This is a phase 1 trial. The researchers need about 86 people to join the trial. There are 2 parts to this trial.
The first part has now finished. In this part the doctors found the best dose of ONX-0801. People had ONX-0801 either once every week, or once every 2 weeks.
In the second part of the trial everybody has the best dose found in the first part.
You have ONX-0801 through a drip into a vein. It takes about 1 hour each time. You have your treatment in one of the following ways:
So your treatment takes about 6 months.
If at any point your cancer starts to grow again, or you have serious side effects, you will stop the trial treatment. Your doctor will discuss whether there are other treatment options for you.
You see the doctors and have some tests before you start treatment. The tests include
The trial team test a sample of your cancer to look for the alpha folate receptor. This will help the researchers learn why ONX-0801 works in some cancers and not others. If a sample is not already available you have a biopsy before you start treatment.
If you have a previous sample available, you might be asked to have an extra biopsy before you start treatment. You don’t have to agree to have this extra biopsy if you don’t want to.
During treatment you go to hospital every week to see a doctor, have a physical examination and blood tests. You have a heart trace every week during your first cycle, then every 3 or 4 weeks after that.
You have lung function tests every 8 weeks during treatment and once after treatment has finished. You may have further scans and tumour marker tests.
About 4 weeks after your finish treatment you have your final hospital visit as part of this trial. You have the same tests you had before joining the trial, unless you have had any of these quite recently. Your involvement in the trial will then stop.
The trial team will continue to see you if you have any side effects. These appointments will stop when the side effects have stopped.
The trial may continue to collect information about your cancer after your last appointment. This will do this by looking at your medical notes.
As ONX-0801 is a new drug, there may be side effects we don’t know about yet. Possible side effects include
While some of these side effects may get worse during the first few doses of ONX-0801, it is possible that some side effects will become less as treatment continues.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Udai Banerji
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.