
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 study is to see how well nilotinib (Tasigna) works as a first treatment for chronic myeloid leukaemia (CML). Most people with chronic myeloid leukaemia (CML) have an abnormal called the Philadelphia chromosome. This develops if some DNA from one chromosome sticks to another when the cell divides, creating an abnormal gene called ‘bcr/abl’. Bcr/abl produces an
called
, which encourages leukaemia cells to grow and multiply.
Doctors usually treat CML with a biological therapy called imatinib. Imatinib is a tyrosine kinase inhibitor. It switches off bcr/abl, stopping production of tyrosine kinase.
This study is looking at a new drug called nilotinib. Nilotinib is very similar to imatinib. Doctors think nilotinib may be better than imatinib at blocking tyrosine kinase. We know from research that this works well to treat CML if you are no longer able to take imatinib.
Doctors want to find out more about nilotinib as a first treatment for CML. And see if it works as well at a lower dose than they have used before. The main aims of this study are to see how well a reduced dose of nilotinib
You can enter this study if you
You cannot enter this study if you
This international study will recruit 60 people. You take nilotinib twice a day for up to 2 years. You take the capsules in the morning and evening. You swallow them with a full glass of water. For 2 hours before and one hour after each dose, you must not eat food or drink anything other than water.
You must also avoid eating grapefruit, orange or star fruit (or drinking these juices) during this study as they can affect how well the drugs work.
Before you start the study, you will see the doctor and have some tests, including
You will have a blood test each week for the first month that you take nilotinib. You will also have an ECG at 2 of these visits.
You then have a blood tests every month while you are taking nilotinib. You may have more ECGs during the study if your doctor thinks you need them.
You will also have a bone marrow test every 3 months until all the blood cells in your bone marrow are normal.
At the end of the study you repeat the tests you had before you started.
Common side effects of nilotinib include
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Michael O’Dwyer
Experimental Cancer Medicine Centre (ECMC)
Cancer Trials Ireland
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.