“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at everolimus and dovitinib for kidney cancer that has spread (DEVELOP)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Everolimus is a type of biological therapy called an mTOR inhibitor. It stops a protein called mTOR from working properly. mTOR controls other proteins that trigger cancer cells to grow. By blocking mTOR, everolimus may help stop cancer growing.
Doctors often use everolimus to treat kidney cancer that has spread. But it doesn’t always work. Doctors want to find out if taking a drug called dovitinib at the same time will help it work better.
Dovitinib is a new drug and is a type of biological therapy called a tyrosine kinase inhibitor or TKI. TKIs block tyrosine kinase, which is a chemical messenger (an enzyme) that sends messages to tell cells to divide and grow. Blocking tyrosine kinase may stop cancer cells growing.
The aims of this trial are to find out
- The best dose of everolimus and dovitinib to use for clear cell kidney cancer that has spread
- More about the side effects
- How well this new combination of treatment works
Who can enter
You may be able to enter this trial if you
- Have clear cell kidney cancer that has spread to another part of your body, apart from your brain
- Have an area of cancer that can be measured on a scan and is at least 10mm across
- Have already had a treatment such as bevacizumab (Avastin), sunitinib (Sutent), sorafenib (Nexavar) or everolimus (Afinitor) but your cancer has continued to grow
- Have satisfactory blood test results
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are prepared to use reliable contraception while you are taking part in the trial
- Are at least 18 years old
You cannot enter this trial if you
- Have clear cell kidney cancer that has spread to your brain
- Have had major surgery in the last 2 weeks
- Are currently having treatment for your cancer
- Have had a bone marrow transplant in the past
- Have diabetes that is not well controlled
- Need to take warfarin to thin your blood
- Have had a heart attack or bypass surgery in the last 6 months
- Have heart failure, high blood pressure or any other serious heart problem
- Have a serious medical condition that affects your lungs (such as pulmonary fibrosis)
- Have a reduced immune system
- Have had any other cancer in the last 2 years, apart from basal cell skin cancer, squamous cell skin cancer, carcinoma in situ or localised cancer of the cervix, carcinoma in situ or localised prostate cancer that has been successfully treated
- Have any other serious medical condition that may affect your treatment or the results of the trial
- Are taking any medications that may interfere with a substance in the body called CYP3A4 – this includes some antibiotics and drugs to prevent fits (your doctor can tell you more about this)
- Are still having side effects from treatment you have had
- Are pregnant or breast feeding
This is a phase 1 trial which is in 2 parts. In the 1st part, the researchers found the best dose of everolimus and dovitinib to give. The 2nd part of the trial is recruiting another 7 people to find out how well the treatment works.
Everyone taking part has both everolimus and dovitinib. You take everolimus tablets every day. And you take dovitinib capsules for 5 days out of every 7, so you don’t take them for 2 days each week. You carry on taking both treatments until there are signs that your cancer has continued to grow, or you have serious side effects.
On certain days, the research team would like to take some blood samples before and after you take the tablets and capsules. This is to help them find out more about what happens to the treatments in the body and how they work.
You will see the doctors and have some tests before you can take part in this trial. The tests include
- A physical examination, blood pressure and pulse
- Blood tests
- Urine test
- Heart trace (ECG)
- CT scan
You see the doctors 3 times in the first 3 weeks. You will need to take the medication for that day to the appointment with you. At each of these visits, you have blood tests before and up to 3 hours after you take your tablets and capsules.
After that you see the trial team every 2 weeks as long as you are having treatment. You have your blood pressure checked and blood samples taken at each appointment. Every 8 weeks you also have urine tests, an ECG and a CT scan.
You see the doctors about 2 months after you stop treatment. After that the trial team will contact your own specialist every 4 months to find out how you are.
Both everolimus and dovitinib have some side effects. The most common side effects of everolimus are
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Sore mouth
- Tiredness (fatigue)
- A skin reaction such as a rash or itchy or dry skin
The side effects of dovitinib we know about so far include
- Feeling or being sick
- Tiredness (fatigue)
- Increased blood pressure
- Redness or soreness on your hands or feet (Palmar-Plantar syndrome)
Please note that it’s possible there may be side effects we don’t know about yet when you have these treatments together.
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 Thomas Powles
Experimental Cancer Medicine Centre (ECMC)
Queen Mary University of London