"He went through six operations and was placed on a clinical trial so he could try new treatments.”
A trial looking at AT9283 for children and young people with solid tumours
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called AT9283 for children and young people with a solid tumour (not
This trial is for children and young people from age 2 up to and including the age of 18. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.
AT9283 stops a protein called aurora kinase working. Aurora kinase is important for cells to divide and grow. Some cancers have too much aurora kinase. These are often cancers that don’t respond to treatment or come back after treatment. Doctors hope that if they can block aurora kinase, they can stop the cancer growing.
The aims of this trial are to find out
- The best dose of AT9283 to give to children and young people
- More about what happens to AT9283 in the body
- More about the side effects
- How well it works
Who can enter
You can enter this trial if you
- Have a solid tumour (not a leukaemia or a lymphoma) that has not responded to, or has come back after, standard treatment
- Are up and about and well enough to have treatment (WHO performance status of 0, 1 or 2 or Lansky score of at least 70)
- Have satisfactory blood test results
- Are prepared to use reliable contraception while you are taking part in this trial and for 6 months afterwards, if you are sexually active
- Are aged between 2 and 18 (inclusive)
You cannot enter this trial if you
- Have had hormone therapy, biological therapy or chemotherapy in the last 4 weeks
- Have had radiotherapy in the last 4 weeks, unless it was for symptom control only
- Have had radiotherapy to more than a quarter of your bone marrow
- Have had a bone marrow transplant using bone marrow from someone else (
allogenic bone marrow transplant)
- Have had a stem cell transplant using your own cells (
autologous stem cell transplant) in the last 3 months
- Are still recovering from major surgery to the chest or tummy (abdomen)
- Have had treatment with an aurora kinase inhibitor before
- Are already part of any other trial looking at treatment for your cancer, or plan to join one
- Still have side effects of treatment you have had (apart from hair loss)
- Have HIV, Hepatitis B or Hepatitis C
- Have heart problems
- Have a history of allergic reactions or immune problems
- Have any other serious medical condition
- Are pregnant or breastfeeding
This is a phase 1 trial of an experimental treatment. Everyone taking part will have AT9283. Doctors are not sure yet how well this treatment will work.
The first few people taking part in this trial will have the lowest dose of AT9283. The next few people taking part will have a higher dose. And so on, until the trial team find the best dose to give. This is called ‘dose escalation’.
If you don’t already have a central line, you will have one put in before you start treatment. This makes it easier to have treatment and take blood samples.
You have AT9283 through your central line into a vein for 72 hours (3 days), once every 3 weeks. Each 3 week period is one cycle of treatment. If you remain well enough for treatment and don’t have any serious side effects, you will have up to 6 cycles to begin with. If tests show that the treatment is working well you may have more than 6 cycles.
The doctors would like to take samples (biopsies) of your cancer and your bone marrow. But this is optional and will depend on the type of cancer you have. If you don’t agree to this you can still take part in the trial. The doctors would like to find out more about what happens to AT9283 in cancer cells. They would do one biopsy before you start treatment and another after your first cycle.
You will see the doctors and have some tests before you can take part in this trial. The tests include
- Physical examination, height and weight
- Blood pressure, temperature and heart rate
- Blood tests
- Urine tests
Heart trace (ECG)
Heart ultrasound(echocardiogram or echo)
- Biopsy of your skin
- CT scan or MRI scan
You will stay in hospital for the first cycle of treatment. The research team will take 8 blood samples in the first 4 days of this cycle. This is so they can see what happens to AT9283 in the body. You may be able to have the rest of the treatment as an out patient, but may need to stay in hospital for a few days of each cycle.
Every week while you are having treatment you see the doctors, have blood tests and a physical examination. You will have a heart ultrasound and a CT or MRI scan every 6 weeks.
You see the trial doctors 4 weeks after your last dose of AT9283. If you are still having side effects you will continue to see them once a month. If you are not having side effects, you will see your own cancer specialist.
AT9283 is a new treatment so there may be side effects we don’t know about yet. It has not been given to children before, but the most common side effects in early phase adult trials were
- A drop in blood cells causing an increased risk of infection, bruising or bleeding problems, tiredness or shortness of breath
- Feeling or being sick
- Tiredness (fatigue)
A small number of people who have had much higher doses of AT9283 had reduced liver function or heart problems. The research team will do regular tests to help stop this happening.
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.
Dr Darren Hargrave
Astex Therapeutics Ltd
Cancer Research UK (Centre for Drug Development)
Children's Cancer and Leukaemia Group (CCLG)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUKD/09/044.