A trial looking at AUY922 for stomach cancer that has spread
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 a drug called AUY922 for stomach cancer that has spread to other parts of the body (advanced stomach cancer).
Doctors often treat advanced stomach cancer with chemotherapy. But the cancer can come back again after treatment. If this happens, you may have more chemotherapy, but researchers are looking for new treatments to help people in this situation. In this trial, they are looking at a new drug called AUY922.
We know from laboratory research that AUY922 can block the activity of an 
called ATPase. ATPase is involved when cells divide. Blocking it may stop cancer cells growing.
In this trial, researchers will compare AUY922 with the chemotherapy drugs docetaxel and irinotecan. The aims of the trial are to
- See if AUY922 helps people with advanced stomach cancer more than one of the chemotherapy drugs
- Find out more about AUY922 and what happens to it in the body
- Learn more about the side effects
Who can enter
You can enter this trial if you
- Have the most common type of stomach cancer called adenocarcinoma, or adenocarcinoma that started at the point where your food pipe (oesophagus) joins your stomach (gastro oesophageal junction)
- Have cancer that has got worse after having 1 type of chemotherapy for advanced cancer – you may have also had chemotherapy after surgery to remove your cancer (
adjuvant therapy ) as long as it was at least 6 months before the cancer came back following this treatment - Have satisfactory blood test results
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are willing to use reliable contraception during the trial and for 4 weeks afterwards if there is any chance you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have cancer that has spread to your brain and is growing or causing symptoms that need treatment
- Have another cancer that needs treating
- Have had chemotherapy in the last 4 weeks (in the last 6 weeks if you had mitomycin or one of a group of drugs called
nitrosoureas ) - Have had major surgery in the last 2 weeks, or earlier if you have not fully recovered yet
- Have had treatment with a monoclonal antibody in the last 4 weeks
- Have had radiotherapy in the last 4 weeks, or in the last 2 weeks if it was radiotherapy for symptoms (palliative radiotherapy)
- Have had an experimental drug or any other anti cancer treatment that reaches the whole body (
systemic treatment ) and there is a chance that any of the drug could still be in your body - Have already had a drug that blocks proteins called HSP90 or HDAC (you can check this with your doctor)
- Are taking drugs to thin the blood such as warfarin (unless it is a low dose you take because you have a central line)
- Are known to be sensitive to
taxanes or similar drugs - Are taking other drugs that may affect an enzyme called CYP3A4 (you can check this with your doctor)
- Have diarrhoea unless it is very mild
- Have a build up of fluid in the abdomen (ascites)
- Have liver or kidney disease
- Have a heart problem that is a cause for concern, or any other medical condition that the trial doctors think could affect you taking part in this trial
- Are known to be HIV positive
- Are pregnant or breastfeeding
Trial design
This is a phase 2 trial. It will recruit about 120 people in different countries around the world. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- People in group 1 have AUY922 through a drip into a vein every week
- People in group 2 have docetaxel or irinotecan through a drip into a vein every 3 weeks
If you are in group 2, the chemotherapy drug you have depends on whether you have already had docetaxel or a similar drug called paclitaxel. If you have, you will have irinotecan in this trial.
Each 3 week period is called a cycle of treatment. As long as you don’t have bad side effects, you can carry on having treatment for as long as it helps you.
The researchers will get a sample of tissue removed when your cancer was diagnosed. If a sample of tissue is not available, they will ask you to have another before you start the trial treatment. They will use these tissue samples, along with blood samples to look for biomarkers. Biomarkers are substances in the body that doctors can measure to see how a disease is developing or how a treatment is working.
If you are in the group having AUY922, the trial team will take a number of blood samples to look at what happens to the drug in the body. This is called .
The researchers will also ask permission to take one extra blood sample. They will use this to learn more about how affect the way people respond to a drug. This is called pharmacogenetics. If you don’t want to give a blood sample for this part of the research, you don’t have to. You can still take part in the main trial.
Hospital visits
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Eye test
- Blood and urine tests
- Chest X-ray
- CT scan or MRI scan
- PET scan
- Heart trace (
ECG ) - Heart ultrasound (
echocardiogram ) or MUGA scan
Throughout the treatment, you go to hospital at least once a week, but there will be extra hospital visits in the first 3 cycles of treatment. During these visits, you have a number of blood tests and ECGs. People in the group having AUY922 will have more ECGs.
Everybody taking part has a CT or MRI scan every 6 weeks and a PET scan in the second and third cycles of treatment.
If you have cancer that has spread to your liver, the researchers may ask you to have some special scans called ‘dynamic contrast enhanced’ MRI (DCE-MRI) scans. You have 2 of these scans before starting treatment and then 1 during the first cycle of treatment and 1 during the third cycle.
When you finish treatment, you will see the trial team within a week and have more tests and scans. You see them again after 4 weeks. A member of the trial team will then contact you by phone every 3 months to see how you are. They will do this until 2 years after the last person joined the trial.
If you stop the trial treatment for any reason other than your cancer getting worse, the trial team will ask you to carry on having CT or MRI scans every 3 months until your cancer does get worse.
Side effects
As AUY922 is a new drug, there may be side effects we don’t know about yet. Known side effects include
- Skin irritation at the site where you have the drip
- Diarrhoea
- Temporary changes to your eyesight
- Feeling or being sick
- A drop in the number of red and white blood cells causing an increased risk of infection and tiredness (
anaemia ) - Changes to the rhythm of your heart
There is more information about possible side effects of docetaxel and irinotecan on CancerHelp UK.
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
Dr Ian Chau
Supported by
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Novartis
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
