"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study looking at AZD4547 for gastro oesophageal cancer and other cancers with changes in the FGFR gene (FGFR study)
This study is looking at a new drug called AZD4547 for cancer of the lower oesophagus (food pipe) cancer at the junction of your food pipe and stomach or stomach cancer (gastro oesophageal cancer) that has extra copies of the FGFR gene. It is also open to people whose cancer has changes (abnormalities) in the FGFR gene.
AZD4547 is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. AZD4547 blocks the action of the FGFR gene.
The aims of this study are to find out
- How well AZD4547 works for people whose cancers has changes in the FGFR gene
- How safe it is
- What the side effects are
Who can enter
You may be able to enter this study if you have any of these
- Stomach (gastric) cancer that has has extra copies of the FGFR gene and has spread into the surrounding tissue or to another part of the body despite having 1 or 2 courses of chemotherapy
- Cancer of the lower oesophagus (food pipe) or cancer of the gastro oesophageal junction that has extra copies of the FGFR gene and has spread into the surrounding tissue or to another part of the body despite having 1 or 2 courses of chemotherapy
- A tissue sample of your cancer that shows a change in the FGFR gene
Everyone in the trial must also
- Have a tissue sample stored from previous surgery or biopsy or be willing to have a small piece of tissue taken from your cancer (biopsy) that the researchers can use to test for the FGFR gene
- Be willing to have biopsies taken from your cancer
- Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
- Be willing to use reliable contraception if there is any chance you or your partner could become pregnant
- Be at least 25 years old or 16 years old if you have a type of bone cancer called osteosarcoma
You cannot enter this study if
- Your cancer has spread to your brain, unless you had treatment for the spread at least a month ago and the cancer spread is now stable
- You had major surgery in the month before starting treatment in this study
- You had radiotherapy to a large area in the last month, or to a small area to relieve symptoms in the past 2 weeks, before starting treatment in this study
- You have side effects from previous treatment, apart from hair loss, unless they were very mild – you must be completely recovered from a drop in blood cells or side effects of the digestive system before starting treatment in this study
- You have high blood pressure that is not controlled
- You have a condition that means you bleed very easily
- You have HIV, hepatitis B or hepatitis C and it is causing problems
- You have a problem with your
digestive systemthat means you aren’t able to absorb tablets properly
- You have a serious heart problem
- You have a serious eye problem
- You have active
- You have had another cancer in the past 5 years apart from successfully treated non melanoma skin cancer or in situ carcinoma of the cervix
- You are allergic to AZD4547, or similar drugs, and their ingredients
- You have any other medical condition that could affect you taking part in this study
- You are pregnant or breastfeeding
This is a phase 2 study. It will recruit 32 people. Everyone taking part will have AZD4547.
AZD4547 is a tablet. You take it twice a day. You can continue taking AZD4547 as long as it is helping you and the side effects aren’t too bad.
The researchers will take some extra blood samples and tissue samples for this trial. They will use these to find out more about your cancer and how the treatment is working. You must agree to these to take part in the trial.
You see the doctor to have some tests before taking part in this study. These tests include
- A physical examination
- Blood tests
- Urine test
- PET scan
- CT scan
- Heart scan (
- Heart trace (
- Eye examination
During treatment you see the doctor every week for a month and then every 3 weeks while having treatment. You have the tests listed above regularly.
You have a small piece of tissue (biopsy) taken from your cancer before starting treatment and another biopsy between days 10 to 14 of treatment.
When you stop taking AZD4547, you see the doctor for the same tests, apart from the PET scan and CT scan. You then see the doctor a month later for a physical examination and blood tests. Your doctor will also talk to you about any further treatment you may have.
AZD4547 is a new drug and there have been only a few studies in humans. So there may be side effects we don’t know about. The side effects reported include
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.
Prof David Cunningham
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust