"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study of WX-554 in people with advanced cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at a drug called WX-554 in people with
WX-554 is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. Researchers hope that WX-554 will stop the cancer growing, but after laboratory work, they now need to test it in people with cancer. The aims of this study are to find out
- The best dose to give
- More about the safety and side effects
- How the body handles the drug, and how the drug affects the body
- How WX-554 affects your cancer
- If there are any features (
biomarkers) in samples that may help develop new treatment in future
Who can enter
You may be able to enter this study if you
- Have any type of cancer except leukaemia or lymphoma, and you have had all the treatment you can but your cancer has continued to grow
- Have cancer that can be easily measured by a doctor or on a scan
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are able to take medication by mouth
- Are willing to let the team study samples of your cancer that are already stored by the hospital
- Have satisfactory blood test results
- Are willing to use reliable contraception during the study and for a month afterwards if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this study if you
- Have cancer that has spread to your brain unless this has been treated, symptoms have not got any worse in the last 4 weeks, and if you are still taking steroids, the dose you are taking has been the same for a while or is being reduced
- Have had major surgery, radiotherapy, immunotherapy or another trial cancer drug in the last 4 weeks – if you have had radiotherapy to control symptoms you may still be able to take part
- Have had chemotherapy in the last 4 weeks (6 weeks if you have had
nitrosourea chemotherapyor mitomycin C)
- Are still having moderate to severe side effects from chemotherapy – if the side effect is hair loss you may still be able to take part
- Have had a similar type of drug to WX-554 before – you can check this with your doctor
- Have any condition that means your body would not be able to absorb, use or get rid of the study drug – you can ask your doctor about this
- Have a condition affecting a vein that drains blood away from the part of your eye called the retina, are at risk of a blood clot in this vein or you have high pressure inside your eye
- Have hepatitis B, hepatitis C or HIV
- Have serious heart problems
- Are pregnant or breastfeeding
- Have any other condition that would make you unwell or affect the results of the study if you took part
This phase 1/2 study will recruit about 50 people. It is split into 2 parts. The part you are in depends on when you join the study.
Part 1 is called a dose escalation study. The first patients taking part will have a low dose of WX-554. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give.
Once they have found the highest safe dose, the study will move on to part 2. The researchers will learn more about how WX-554 works and any side effects it causes. The team may slightly change the dose level, and how often you take the drug.
Your study doctor will tell you how often to take the capsules during each 3 week cycle of treatment. You take WX-554 capsules with food once a day on the days your study doctor tells you to. On days that you visit clinic, you should not take the drug until you have had any tests you may need. The number of cycles you have will depend on how well you cope with the study drug.
The team will give you a diary to write down the date and time of each dose you take. They will also ask if you would be happy to give extra small samples of
- Cancer tissue
- Skin (from your buttocks or arm)
You do not have to give these if you don’t want to. You can still take part in the rest of the study.
If the drug is safe and your cancer does not get worse, you can continue taking it for as long as you can cope with any side effects and your doctor thinks it is helping you.
Before you join the study you will see the doctor and have some tests to make sure that you can take part. These include
If you have agreed to, you will also give a sample of tissue or skin (biopsy) to look for
You visit the hospital 6 times during your first cycle of treatment. You will have lots of blood tests during this time. You will have heart traces if your doctor thinks you need them. Some of the visits will take up to 11 hours, and you may need to stay in hospital overnight so that the team can take blood at certain times. They will tell you more about these visits. If you have agreed to give samples for the extra studies, you will do this during the first cycle.
You then visit the hospital once at the beginning of each treatment cycle for more blood tests and a heart trace. These visits will be shorter.
You will have an MRI scan or CT scan and a blood test if needed at the end of cycle 2, and then every other (alternate) treatment cycle.
You visit the hospital again both a week and a month after you finish the study drug, to see the doctor and have blood tests and a heart trace.
All medicines have side effects, and the research team do not yet know all the side effects for WX-554. This is one of the reasons for the study. Possible side effects they know about so far include
Possible risks of a biopsy include
- Pain and infection where you had the biopsy
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.
Professor Ruth Plummer
Experimental Cancer Medicine Centre (ECMC)