Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial of TKI258 for advanced womb cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at TKI258 (also known as dovitinib) for womb (endometrial) cancer.
If womb cancer has spread to other parts of the body, or has come back after it was first treated, it is called advanced womb cancer. Doctors can use treatments such as chemotherapy for advanced womb cancer, but the cancer may continue to grow or come back again and researchers are looking for ways to help women in this situation. In this trial, they are looking at a drug called TKI258, which is also known as Dovitinib.
In about 1in 10 womb cancers, there is a change to a gene called FGFR-2. Researchers want to find out whether having a changed FGFR-2 gene affects how well dovitinib works. So before you can join the trial, the researchers need a sample of your cancer to see if the gene is changed (mutated) or if it is normal.
The aim of the trial is to see if dovitinib helps women who have advanced womb cancer with either a normal or a changed FGFR-2 gene.
Who can enter
You may be able to enter this trial if you
- Have advanced womb cancer that can be measured on a scan and has got worse despite having other treatment
- Have already had at least 1 chemotherapy drug for advanced womb cancer
- Have completely recovered from the side effects of any other cancer treatment (apart from hair loss) unless they are very mild
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
- Are at least 18 years old
You cannot enter this trial if you
- Have cancer that could be cured with surgery or radiotherapy
- Have cancer that has spread to your brain
- Have sarcoma of the womb, or a rare type of cancer called a mixed Mullerian tumour
- Have had more than 1 other type of treatment for advanced womb cancer
- Have had any other cancer in the last 3 years, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
- Have had a monoclonal antibody,
immunotherapy, hormone therapy, or chemotherapy in the last 4 weeks (6 weeks if you had drugs called nitrosoureasor mitomycin C)
- Have already had a drug that targets a growth factor called FGFR (your doctor can confirm this)
- Have had another type of cancer growth blocker in the last 2 weeks or have not recovered from the side effects of earlier treatment
- Have had radiotherapy in the last 4 weeks (2 weeks if it was radiotherapy to your bones)
- Have had major surgery in the last 4 weeks or have not recovered from earlier surgery
- Have had another experimental drug in the last month – or earlier if there is any chance some of the drug could still be in your body
- Have had a blood clot in your lungs or in one of the deep veins of your body in the last 6 months
- Have had a heart attack in the last 6 months, or have certain other heart problems – the trial team can advise you about this
- Have high blood pressure that cannot be controlled with medication
- Have a problem with your
digestive systemthat means you may not be able to absorb the trial drug
- Have scarring of the liver (
cirrhosis), hepatitis B or hepatitis C
- Are known to be HIV positive
- Take certain medicines to thin your blood – the trial team can confirm this, but it is important that you don’t stop taking any medication without speaking to your doctor
- Have any other serious medical condition that the trial team think could affect you taking part
- Are pregnant or breastfeeding
This phase 2 trial will recruit about 80 women.
Before you can join the trial, the researchers need to get a sample of your cancer to see if it has a normal FGFR-2 gene, or if the gene is changed (mutated). They will try to get a sample of tissue that was removed when you had surgery or a
The trial team need to recruit women whose cancer has a normal FGFR-2 gene, as well as women whose cancer has the changed gene. If they have already recruited enough people with the same form of FGFR-2 found in your cancer, you will not be able to take part.
If you do take part in the trial, you take dovitinib capsules for 5 days each week. As long as you don’t have bad side effects, you can carry on taking it for as long as it helps you.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- CT scan or MRI scan
- Bone scan or X-rays
- Heart trace (
- Heart ultrasound (
echocardiogram) or MUGA scan
You go to hospital 5 times in the first 7 weeks of treatment and then once every 3 weeks after that. You have a blood test each time.
You have a CT or MRI scan every 6 weeks and you may have a PET-CT scan to see how well the treatment is working. You have more heart traces and heart scans. And you may have more bone scans.
When you finish treatment, you see the study team again within the following week. After that, they will contact your doctor every 6 weeks to see how you are getting on. They will continue to do this until the trial has completely finished.
As dovitinib is still quite a new drug, there may be side effects we don’t know about yet. In earlier trials, the side effects have included
- Feeling or being sick
- Weakness or tiredness (fatigue)
- Loss of appetite or weight loss
- Shortness of breath
- A drop in the number of blood cells causing an increase risk of bleeding, tiredness and breathlessness
- Tummy (abdominal) or back pain
- High temperature (fever)
- Changes to the way your liver works
- Taste changes or a dry mouth
- High blood pressure
- Swelling – usually in the legs
- Urine infection
- Upset stomach or indigestion
The trial team will talk to you about all the possible side effects before you agree to take part.
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 Rebecca Kristeleit
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer