"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at AZD4547 or paclitaxel for advanced stomach cancer (SHINE trial)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing AZD4547 and paclitaxel for stomach cancer that has spread.
Doctors often use chemotherapy drugs such as paclitaxel (Taxol) to treat stomach cancer that has spread. But sometimes it doesn’t work very well and they are keen to find new treatments that work better. This trial is looking at a new drug called AZD4547.
It works by targeting a protein on the cancer cell called fibroblast growth factor receptor 2 (FGFR2). This trial will recruit people whose stomach cancer cells have lots of these receptors.
The aims of this trial are to find out
- How well AZD4547 works for stomach cancer that has spread
- More about the side effects
Who can enter
You may be able to enter this trial if you
- Have cancer of the stomach (gastric cancer), the bottom of the oesophagus (foodpipe) or the area where the stomach meets the oesophagus (the gastro-oesophageal junction) which has spread
- Have cancer cells with a large number of FGRF2 receptors (this will be tested as part of the trial)
- Have an area of cancer that can be measured on a scan
- Are due to have paclitaxel chemotherapy
- Have already had treatment with at least 1 type of chemotherapy or chemoradiotherapy, but your cancer has continued to grow
- Have satisfactory blood test results
- Are happy for the trial team to take a sample (biopsy) of your cancer, or to use some tissue from a biopsy that was taken in the past
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are willing to use reliable contraception during the trial if there is any chance that you or your partner could become pregnant
- Are at least 25 years old
You cannot enter this trial if you
- Have cancer that has spread to your brain or spinal cord
- Have already had treatment with
taxanechemotherapy (such as paclitaxel or docetaxel), unless it was before an operation to remove your cancer and was at least 6 months ago
- Have had any treatment for your cancer in the last 4 weeks
- Have already had AZD4547(or any other treatment that targets FGFRs)
- Have had major surgery in the last 4 weeks
- Have had radiotherapy to a large area of your body in the last 4 weeks (you may be able to take part if you’ve had radiotherapy to just one area to treat symptoms, as long as this was at least 2 weeks ago)
- Have taken part in any other clinical trial in the last 4 weeks
- Have a condition such as diabetes, high blood pressure or an infection that cannot be controlled with medication
- Know you have Hepatitis B, Hepatitis C or HIV (you won’t be tested as part of this trial)
- Have a heart condition such as heart failure or an abnormal heart rhythm
- Have an eye condition such as macular degeneration or problems with your retina (a thin layer of tissue at the back of your eye)
- Have any problems absorbing medicines from your stomach
- Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least 5 years ago
- Are pregnant or breastfeeding
This is a phase 2 trial. It will recruit about 240 people with advanced stomach cancer. It is a randomised trial. The people taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Group 1 have AZD4547 tablets once a day for 2 weeks out of every 3. You continue to take the tablets until there are signs that your cancer has started to grow again.
Group 2 have paclitaxel through a drip into a vein on 3 days out of every 4 weeks. Each dose takes about an hour. You continue with treatment until there are signs that your cancer has started to grow again.
If you agree to take part in this trial, the researchers will ask for an extra sample of tissue and blood. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.
You will see the doctors and have some tests before you take part in this trial.
First, the research team will look at a sample of your cancer to see how many FGFR2 receptors you have to make sure you can take part in the trial.
Other tests you have include
- Physical examination
- Blood pressure, temperature and heart rate
- Blood tests
- Urine test
- Heart trace (
- Heart ultrasound (
echocardiogram) or MUGA scan
- CT scan or MRI scan
- Eye examination
You see the doctors and have blood tests regularly while you are having treatment. Exactly how often will depend on which group you are in. The trial team will be able to tell you more about this.
You will have a CT or MRI scan every 8 weeks during treatment.
When you finish treatment, you see the trial team again about a month later.
As AZD4547 is a new drug, there may be side effects that doctors don’t know about yet. Possible side effects include
- Dryness of the eyes, mouth and skin
- Hair loss
- Brittle and split nails, or change of nail colour
- Sore mouth
- Increase in the level of a mineral called phosphate in your blood
- Increase in fluid in the eye (this is temporary if it is diagnosed early, so you will have tests to check for it during the trial)
The side effects of paclitaxel include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Numbness and tingling in your hands and feet (peripheral neuropathy)
- Aching joints and muscles
- Tiredness (fatigue)
- Mild allergic reaction such as a rash or red face
- Feeling or being sick
- Hair loss
- Low blood pressure
- Sore mouth
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.
Dr Was Mansoor
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer