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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types

Status:

Closed

Phase:

Phase 1

A trial for people with solid tumours that have spread (advanced cancer Open a glossary item) and that have a change on the cMET gene. A solid tumour Open a glossary item is any type of cancer apart from those of the blood or lymphatic system such as leukaemia Open a glossary item or lymphoma Open a glossary item

This trial is looking at how a drug called INC280 changes the way caffeine and midazolam are broken down by the body.

More about this trial

The cMET gene Open a glossary item sends signals to the cells Open a glossary item telling them when to grow or to stop growing. Different types of cancer can have a change in this gene.  

Researchers think a drug called INC280 can block the effects of the cMET gene and stop cancer cells from growing. 

INC280 has been given to a small number of people but researchers want to find out more about. They want to see how this drug changes the way other drugs are broken down by the body. 

In this trial, researchers are looking at 2 drugs 

  • caffeine
  • midazolam

Caffeine is found in coffee, tea or chocolate. It is also found in painkillers Open a glossary item and cold medicines. 

Midazolam is given to calm, or to make people sleepy and relaxed before medical tests (sedative Open a glossary item).

The aims of this trial are to

  • find out how caffeine and midazolam are broken down by your body after you have had INC280 (pharmacokinetics Open a glossary item
  • learn more about the side effects of INC280
  • find out if INC280 can help people with advanced solid cancer that have a change on the cMET gene

Who can enter

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 Open a glossary item, 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 Open a glossary item 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 Open a glossary item 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

Trial design

This is an international phase 1 trial. The researchers need about 32 people to take part worldwide and hope that around 4 people from the UK will take part.  

The first day of treatment is called day 1. Everyone has caffeine and midazolam on day 1. After this you have a break of 2 days where you do not take any drugs. 

On day 4 you start the INC280 tablets. You take the tablets every day, twice a day. You cannot eat for at least 1 hour before the tablets and after you have had the tablets you must wait at least 2 hours before eating.   

On day 9 you have caffeine and midazolam again. After that you have INC280 twice a day. You continue to take it for as long as it helps you and the side effects aren’t too bad. 

Blood tests 
You have some extra blood tests as part of this trial. The blood tests will be done before you take the drugs and then at set times during the trial. 

Researchers will ask to store the blood samples and use them in future studies to look for substances called biomarkers Open a glossary item

You do not have to agree to have your blood stored if you don’t want to. You can still take part in the trial.

Tissue sample
Before you start treatment the trial team need to check if your cancer has a change on the cMET gene. They will ask to use a tissue sample of your cancer taken either when you were diagnosed or during other treatments if available. 

If there is not a suitable sample available the researchers will ask you to have one taken (biopsy Open a glossary item).   

Pregnancy
If you or your partner become pregnant during treatment, or 7 days after stopping INC280, the trial team will ask to look at the medical records of you, your partner and the baby until they are born. 

Only people involved in this research will look at your records and your details will be removed so that no one will be able to identify you. You do not have to agree to the trial team doing this if you don’t want them to.

Hospital visits

You see a doctor and have some tests before taking part. These tests include: 

  • A physical examination
  • Heart trace (ECG Open a glossary item)
  • CT scan or MRI scan
  • Bone scan
  • Photograph of lesions (if you have cancer lesions on the skin)
  • Blood tests
  • Urine test

You see the doctor 9 days after you start the drugs and every 3 weeks after. 

During each visit you have 

  • A physical examination
  • Blood tests 
  • Heart trace (if needed)

Because of the extra blood tests (pharmacokinetics) you may need to stay in hospital for 2 nights. This would be on day 1 of treatment and then day 9. The trial team will give you more information about this. 

You have a CT or an MRI scan every 6 weeks. This continues as long as your cancer stays the same and does not get worse. If your cancer gets worse, you stop INC280. 

When you stop treatment you see the trial team 

  • after 7 days
  • after 30 days

Side effects

The trial team monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

INC280 is a new drug that has only been given to a small number of people. There may be side effects we don’t know about yet. The most common side effects of INC280 are

The most common side effects of caffeine are

  • feeling restless 
  • anxiety
  • sleeping problems
  • shaking or muscle twitching 
  • tummy (abdomen) pain 

The most common side effects of midazolam are

  • anxiety 
  • pain in your chest
  • confusion

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Moditha Nawinne

Supported by

Novartis 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14111

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

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"I am glad that taking part in a trial might help others on their own cancer journey.”

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