A trial looking at how INC280 affects caffeine and midazolam in people with solid tumours

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

You may be able to join this trial if all of the following apply

• You have a solid tumour (not a leukaemia or lymphoma) that has spread to another part of your body
• You are not able to have any treatment to cure your cancer such as chemotherapy, surgery or radiotherapy
• Your cancer has a change on the cMET gene - the doctors will check for this
• You have at least 1 area of cancer that hasn’t been treated with radiotherapy , can be seen on a scan and measures at least 10 mm
• You have satisfactory blood tests results
• You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1) 
• You have a satisfactory heart rate 
• You are at least 18 years old
• You are willing to use reliable contraception during treatment and for 7 days after the final dose of INC280 if there is any possibility you or your partner could become pregnant. If you are a man you must use a condom. 

You cannot join this trial if any of these apply

• Your cancer has spread to your brain or the surrounding tissues (carcinomatous meningitis). If your cancer has spread to your brain you may be able to take part if any symptoms you have are stable for 2 weeks before you start the treatment
• You have had radiotherapy to your lungs in the past 4 weeks or you had radiotherapy to any part of your body in the past 2 weeks
• You have had a major surgery in the past 4 weeks. If you had a small operation where your doctor looked inside your chest through a camera you may still be able to take part
• You have another cancer that needs treatment
• You have moderate or severe side effects from any previous treatments (apart from hair loss)
• You are known to be sensitive to INC280, caffeine, midazolam or anything it contains  
• You have recently taken drugs that affect some enzymes called CYP3A4, CYP1A2 (such as tobacco), can reduce the amount of acid in your stomach (proton pump inhibitors) or can affect your heart function 
• You have taken a herbal remedy in the past 5 days or you have had foods with theobromine (such as chocolate), grapefruit or chargrilled meat in the past 3 days
• You have had more than 1 alcoholic drink every day in the past 3 days – 1 drink is 150 ml of wine or 360 ml of beer
• You have taken midazolam or any drinks with caffeine (such as tea, coffee or cola) in the past 2 days 
• You have not been on a stable dose of corticosteroids (drugs that damp down your immune system in the past 5 days
• You have heart problems such as congestive heart failure, high blood pressure that is not controlled by medication or angina that is not controlled
• You have problems with your digestive system such as ulcers, constantly feeling or being sick, diarrhoea or a malabsorption syndrome
• You have hepatitis B or hepatitis C
• You have any other serious medical condition or mental health problem that the trial team think could affect you taking part  
• You are pregnant or breastfeeding