
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at rigosertib for people who have already had treatment for their myelodysplastic syndrome (MDS).
Myelodysplastic syndrome (MDS) causes the bone marrow to produce blood cells that aren’t mature and don’t function properly. This causes a drop in the normal blood cells.
Treatment for MDS can include chemotherapy such as azacitidine and a stem cell transplant. Unfortunately sometimes these treatments do not work. And the MDS continues to get worse or comes back after treatment.
Researchers want to see if rigosertib can help people in this situation. They will compare rigosertib with the doctor’s choice of standard treatment.
The aims of this trial are to find:
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 all of the following apply. You have myelodysplastic syndrome (MDS) and you are in one of the following situations:
And all of the following apply:
You cannot join this trial if any of these apply.
Cancer related
Medical conditions
Other
This is a phase 3 trial. The researchers need 225 people to join.
It is a randomised trial. People taking part are put into 1 of 2 treatment groups by a computer. Neither you or your doctor can choose which group you are in. The 2 groups are:
You have a 2 out of 3 chance of being in the rigosertib group.
Before starting rigosertib you have a central line or portacath put in if you don’t already have one.
You have a pump attached to the central line that delivers the rigosertib continuously. You have it over 3 days.
At the start you have it every 2 weeks for 16 weeks. Afterwards it is every 4 weeks.
You continue having rigosertib as long as it is helping and the side effects aren’t too bad.
If you are not having rigosertib your doctor will talk to you about what other treatment might be best for you. This could include more chemotherapy or supportive treatment such as blood transfusions.
Samples
The researchers will ask for samples of your bone marrow and blood. These are taken when you have a bone marrow test and blood tests done as part of your routine care.
These samples are used to find out more about MDS. They will also use the blood samples to find what happens to rigosertib in the body.
You don’t have to agree to give these samples to the researchers. You can still take part in the trial.
Quality of life
You fill in a questionnaire before you start treatment, then every 4 weeks during treatment and at the end of treatment. The questions will ask about any symptoms you have and how you are feeling. This is a quality of life study.
You see the doctor to have some tests before taking part. These tests include:
During treatment you see the doctor regularly. You have:
You have a bone marrow test every 2 months up to 6 months and then a year after starting treatment.
At the end of treatment you see the doctor for a physical examination and blood tests.
After treatment the researchers will phone every month to see how you are and ask if you have started any more treatment. If you prefer not to be phoned they can contact your family doctor (GP).
Rigosertib might have side effects we don’t know about. The most common side effects reported include:
Your doctor will talk to you about the side effects of rigosertib and any other treatment you might have before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Ghulam Mufti
Onconova Therapeutics, Inc
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”