
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 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
You can enter this trial if you
You cannot enter this trial if you
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.
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.
You will see the doctors and have some tests before you start treatment. The tests include
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.
As AUY922 is a new drug, there may be side effects we don’t know about yet. Known side effects include
There is more information about possible side effects of docetaxel and irinotecan on CancerHelp UK.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Ian Chau
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Novartis
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.