A trial of rigosertib for myelodysplastic syndrome (INSPIRE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
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.
More about this trial
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:
- how well rigosertib works for people with MDS that has continued to get worse during treatment or came back afterwards
- how rigosertib affects quality of life
- how safe it is
- what happens to rigosertib in the body
Who can enter
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:
- Your MDS didn’t get any better after treatment with azacitidine or decitabine
- Your MDS continued to get worse while having azacitidine or decitabine
- Your MDS came back after having responded to azacitidine or decitabine
- You are unable to have azacitidine or decitabine
- You have MDS with the 5 q syndrome and it did not respond to, or got worse, while taking lenalidomide
And all of the following apply:
- You have between 5% and 30% blast cells in your bone marrow
- Your blood test results show you have a low red blood cell count, low platelets or a low neutrophil count
- All your other blood results are satisfactory
- Your last dose of azacitidine or decitabine was within the past 6 months
- Your total time of any MDS treatment was 9 months or less,and, or you had a total of 9 cycles of treatment in 12 months or less
- You had an allogeneic stem cell transplant that was not successful or you were not able to have a transplant or did not want to have one
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You are between 18 and 81 years old
- You are willing to use reliable contraception during treatment and for a month afterwards if there is any possibility you or your partner could become pregnant
You cannot join this trial if any of these apply.
Cancer related
- You have been diagnosed with acute myeloid leukaemia (AML) and the blast cells in your bone marrow or blood was or is greater than 30%
- You are having an allogeneic stem cell transplant
- You are able to have chemotherapy to get rid of the blast cells in your bone marrow (a remission)
- You have had treatment for MDS in the past 4 weeks apart from treatment such as growth factors to help control the symptoms
- You are currently having treatment for MDS including as part of another clinical trial
- You have had previous treatment with rigosertib
- You have had another cancer in the past year apart from non melanoma skin cancer or in situ carcinoma of the cervix or breast
Medical conditions
- You have an infection that isn’t responding to treatment
- You have HIV that isn't controlled
- You have or had hepatitis B and there are antibodies to it in your blood
- You have or had hepatitis C and the virus is present in your blood
- You have not fully recovered from any major surgery
- You are to have major surgery in the 3 weeks before been randomised for this trial
- You have high blood pressure that isn’t controlled by medication
- You have had fits (seizures) in the 3 months before been randomised and they are new
- You have fits that are not controlled by medication
- You are having steroids unless it is for an ongoing (chronic) condition and the dose is 20mg a day or less
- You have any other medical or mental health condition that the trial team think could affect you taking part
Other
- You are pregnant or breastfeeding
Trial design
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:
- rigosertib
- doctor’s choice of treatment
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.
Hospital visits
You see the doctor to have some tests before taking part. These tests include:
- a physical examination
- blood tests
- urine test
- heart trace (ECG)
- bone marrow test if needed
During treatment you see the doctor regularly. You have:
- blood tests every week
- a physical examination every 2 weeks
- a urine test every 4 weeks
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).
Side effects
Rigosertib might have side effects we don’t know about. The most common side effects reported include:
- a drop in blood cells causing shortness of breath, an increased risk of infection, bruising and bleeding
- diarrhoea or constipation
- tiredness
- feeling or being sick
- feeling of fullness and tightness in the stomach (bloating)
- tummy (abdominal) pain
- difficulty sleeping or falling asleep
- headache
- dizziness
- difficulty or pain passing urine
- blood in the urine
- high temperature (fever)
- a change to the way your liver works
- a decrease in the amount of potassium and sodium on the blood
- a decrease in the amount of the protein albumin in the blood causing general swelling
- swelling of the arms and legs
- loss of appetite and changes to taste
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.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Ghulam Mufti
Supported by
Onconova Therapeutics, Inc
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
