A study of ibrutinib for oesophageal cancer or stomach cancer (iMYC)

Cancer type:

Oesophageal cancer
Stomach cancer

Status:

Open

Phase:

Phase 2

This study is looking at ibrutinib for people whose cancer cells have certain gene changes. 

It is a study for people with:

and the cancer has spread into nearby tissues or to another part of the body.

More about this trial

HER2 and c-MYC are genes Open a glossary item in the body. Some stomach and oesophageal cancers have too many copies of either HER2, c-MYC, or both genes. Having too many copies can make the cancer cells divide and grow in an uncontrolled way. Too many copies of the HER2 gene is also called HER2 Open a glossary item positive cancer.

Ibrutinib is a type of targeted cancer drug called a cancer growth blocker. It stops signals that cancer cells use to divide and grow. It is already used to treat some blood cancers. 

Laboratory studies show that ibrutinib may work for stomach and oesophageal cancers that have too many copies of either the HER2 or c-MYC genes, or both. Researchers don’t know for sure so they want to find out more. 

The aims of the study are to find out:

  • how well ibrutinib works
  • how safe it is
  • more about the side effects

Who can enter

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

Who can take part

You may be able to join this study if you have one of the following cancers:

  • cancer of the food pipe (oesophageal cancer)
  • cancer where the food pipe meets the stomach (gastro oesophageal junction cancer)
  • stomach cancer

And:

  • you have a type of cancer called squamous cell cancer Open a glossary item or adenocarcinoma Open a glossary item
  • the cancer has spread into nearby tissues (locally advanced) or has spread to another part of the body (metastatic) and cannot be removed with surgery
  • your cancer cells have too many copies of HER2, c-MYC or both 
  • your cancer got worse after at least 1 course of chemotherapy for advanced cancer. For HER2 positive cancer you may have had treatment such as trastuzumab alongside chemotherapy.
  • you have at least one area of cancer that can be measured on a scan
  • there is a sample of tissue available for the study team to do some tests on or you are willing for the doctors to take a new sample
  • you are well enough to be up and about for at least half the day (performance status 0,1 or 2)
  • you have satisfactory blood test results
  • you are willing to use reliable contraception during the study and for 3 months afterwards if there is any chance that you or your partner could become pregnant
  • you are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. 

Cancer related
You: 

  • have cancer spread to the brain that is causing symptoms
  • have had any other treatment such as chemotherapy, immunotherapy, or an experimental drug in the 4 weeks before joining the study
  • have had a bleed from the tumour in your stomach or oesophagus 

Other medical conditions
You:

  • have had a stroke or bleed into the brain within 6 months of joining the study
  • have problems with your heart, such as a heart attack in the last 6 months, an abnormal rhythm of your heart, congestive heart failure or any other significant heart problem 
  • have had major surgery in the 4 weeks before joining the study
  • have severe liver damage (Child-Pugh Class C)
  • take warfarin medication to thin your blood
  • you have an active infection that needs antibiotic treatment with a drip
  • have an active hepatitis B or hepatitis C infection
  • have HIV
  • have any other serious medical condition or mental health problem that the study team think could affect you taking part

Other 
You: 

  • are allergic to the drugs, or their ingredients, used in this study
  • take St. John’s Wort
  • take medication that blocks an enzyme called CYP3A4 
  • have had a live vaccine Open a glossary item in the 4 weeks before joining the study
  • are pregnant or breastfeeding

Trial design

This phase 2 study is taking place at the Royal Marsden Hospital in London and Sutton. The researchers need 17 people to take part.

The researchers will test a tissue sample (biopsy Open a glossary item) and a blood sample for the HER2 and c-MYC genes. They will test samples taken when you were first diagnosed and had surgery or a biopsy. If no suitable sample is available they may give you the option to undergo a further biopsy to provide a new sample for testing. 

If your stomach or oesophageal cancer cells make too many copies HER2 or c-MYC, you might be suitable to take part in the study. If not, your doctor will discuss other treatment options with you.

Everyone enrolled onto the study has ibrutinib. It is a medication you take by mouth. You take 4 capsules once a day, everyday.

You have treatment for as long as it is working and the side effects are manageable. 

Tissues samples (biopsies)
The study team will also ask to take 3 extra tissue samples. But you don’t have to agree to this if you don’t want to. You can still take part in the study.

They will ask if any samples left over can be used for research purposes. 

Blood samples 
The doctors will also ask for some extra blood samples. Where possible you have these at the same time as your routine blood tests.

They plan to use the samples to look at:

  • what happens to ibrutinib in the body (pharmacokinetics) Open a glossary item
  • biomarkers Open a glossary item to help work out why treatment might work for some people and not others 
  • genes Open a glossary item

Quality of life
The study team will ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study. Open a glossary item

Hospital visits

You’ll see a doctor and have some tests before you start treatment. The tests include:

You take ibrutinib at home. In the first month of treatment you go to the hospital once a week. Then you go once a month. You shouldn’t need to stay overnight. 

The study team give you a fresh supply of tablets each month. 

You have a CT scan every 8 weeks.

You have a PET scan at:

  • 14 days
  • 8 weeks

When you stop treatment, you see the study team a month later for a check up and some blood tests. 

Side effects

The most common side effects of ibrutinib are:

  • muscle and joint pain
  • tiredness (fatigue)
  • bruising 
  • skin rash or infections
  • small red or purple spots on the skin caused by bleeding under the skin 
  • feeling or being sick
  • diarrhoea or constipation
  • cough 
  • sores in the mouth
  • sinus infection
  • a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • high temperatures (fever)
  • dizziness
  • swelling of the hands or feet
  • colds
  • urine infections
  • shortness of breath
  • pneumonia
  • headache
  • muscle spasms
  • loss of appetite
  • high blood pressure
  • nose bleeds

Location

London
Sutton

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 Ian Chau

Supported by

The Royal Marsden NHS Foundation Trust
Janssen Pharmaceuticals

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14977

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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