
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is trying to find out more about how nilotinib affects some important body . To help find out, the researchers are using another drug called midazolam. This study is for people with chronic myeloid leukaemia (CML).
Doctors may use nilotinib (also called Tasigna) to treat CML. It is a type of biological therapy called a tyrosine kinase inhibitor (TKI).
Nilotinib affects certain proteins in the body called cytochrome P (CYP) enzymes. These enzymes help the body to breakdown and get rid of a wide range of drugs.
Researchers want to learn more about how nilotinib affects CYP enzymes and the way other drugs are broken down. Studying what happens to a drug in the body is called .
In this study, the researchers are using a drug called midazolam, which they know is very sensitive to CYP enzymes. Midazolam is a drug doctors give to calm anxiety, or to make people drowsy and relaxed before medical tests (a ).
Researchers think that studying what happens to midazolam when you have nilotinib is a good way of learning more about how much nilotinib affects CYP enzymes.
You can enter this trial if you
You cannot enter this trial if you
This is a phase 1 trial. It will recruit about 22 people. Everybody taking part will have midazolam and nilotinib.
There are 2 parts to this study. The first is called ‘the core study’, the second is called ‘the extension phase’. The core study lasts for 2 weeks.
The trial team will ask you not to eat anything for at least 10 hours before having the first dose of midazolam and to do the same again before having both drugs on day 13.
If you choose to carry on into the extension phase of the study, you will take nilotinib capsules for up to 12 months.
You will see the doctors and have some tests before you start treatment. The tests include
You may stay in hospital for a night or 2 at the beginning of the study and again at the end. Even if you don’t stay in hospital overnight you will be there for at least 12 hours on day 1 and day 13.
Having midazolam is likely to make you go to sleep for a while, or at least make you very drowsy.
You have a number of blood tests and ECGs throughout the first day. And you have another blood test the next day.
You take nilotinib capsules at home for the next 11 days. A member of the trial team may contact you by phone every few days to see how you are getting on. You go back to hospital on the 7th day to have ECGs both before and after taking the capsules.
On day 13, you have both drugs, and a number of blood tests and ECGs throughout the day. Day 14 is the end of the core phase. The trial doctor will examine you again and you have another ECG, as well as blood and urine tests.
A member of the trial team will contact you by phone about a month later to see how you are.
If you take part in the extension phase, you have
The possible side effects of nilotinib include
There is more information about other possible side effects of nilotinib on CancerHelp UK.
The possible side effects of midazolam include
You must not eat certain fruits such as grapefruit (or drink these juices) during this trial as they can affect how the drugs work and make side effects worse.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Tessa Holyoake
Experimental Cancer Medicine Centre (ECMC)
Novartis
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.