“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A study of axitinib for kidney cancer (NAXIVA)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at having axitinib before surgery for kidney cancer to help shrink the cancer or stop it growing. It is open to people who can have surgery to remove all, or part, of their cancer.
More about this trial
Axitinib (Inlyta) is a targeted cancer drug called a tyrosine inhibitor. It works by blocking certain proteins called tyrosine kinases that signal the cancer cell to grow.
Previous studies suggest that tyrosine inhibitors might slow, or stop the growth of cancers. It might also reduce the size of the cancer.
At the moment axitinib is used after surgery for kidney cancer that has spread to another part of the body. In this study researchers want to know if having axitinib before surgery can stop the cancer from growing or shrink the cancer. This could then reduce the amount of surgery you need to remove the kidney cancer.
Everyone in this study will take axitinib for a short time before their surgery.
The main aim of this study is see if axitinib can stop kidney cancer from growing or shrink it before having surgery.
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if all of the following apply. You:
- have stage 3 kidney cancer
- have a type of renal cell cancer called clear cell
- are suitable for and willing to have surgery
- have a urine dipstick test that shows there is less than 2+ of protein in your urine. If there is 2+ or more protein a 24 hour urine collection must show there is less than 2 grams of protein in your urine over the 24 hours or you have a blood test that shows the urinary protein creatnine ratio (PCR) is below a certain level
- have satisfactory blood tests results
- can do everything apart from heavy physical work (performance status 0 or 1)
- are willing to use reliable contraception during treatment and a week afterwards for women and at least 6 months afterwards for men
- are at least 18 years old
You cannot join this study if any of these apply.
- have cancer that has spread to more than 1 lymph node
- have cancer that has spread to another part of the body that is growing and hasn’t been treated, and you are suitable to have surgery to reduce the cancer and your doctor thinks there is a high risk your cancer might come back after surgery
- have another cancer apart from successfully treated non melanoma skin cancer, in situ carcinoma of the cervix, prostate cancer that is completely in the prostate that has been successfully treated with the aim to cure, is a low to moderate risk of coming back and your PSA isn't rising or your prostate cancer is stage T1 or T2a, your Gleason score is 6 and your PSA is 10 or lower and you haven't had treatment but are under active survelliance
- have cancer that is causing pressure on your spinal cord (spinal cord compression)
- have cancer that has spread to the lining of your brain
- have signs or symptoms of severe liver disease, endocrine disease or lung disease that is getting worse or not controlled by medication
- have liquid food through a drip into a vein (parental nutrition)
- have had bleeding from your stomach or gut in the past 3 months that isn’t due to your cancer
- have had surgery to your stomach or gut that affects how well you absorb food and medication
- have a disorder that affects how well your digestive system absorbs food or medication
- have a peptic ulcer that needed treatment in the past 6 months
- have had a heart attack, heart failure or angina in the past 12 months
- have had heart surgery called an artery bypass graft in the past 12 months
- have had a stroke (CVA) or mini stroke (TIA) in the past 12 months
- have fits (seizures)
- have high blood pressure that isn’t controlled by medication
- have HIV or AIDs
- have very bad liver damage
- are taking, or might need to take, medication that affects the CYP enzymes
- are taking blood thinning medication, such as warfarin, that affects how vitamin K works in the body. You might be able to join the study if you are taking it to keep a central line open or to prevent a blood clot (DVT)
- are very sensitive to axitinib or any of its ingredients. People with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not join the study
- are pregnant or breastfeeding
This is a phase 2 study. The study team need 20 people to join.
Everyone takes axitinib for 8 weeks before surgery. You have your surgery during week 9.
Axitinib is a tablet you take twice a day. Your doctor will tell you how many to take. After 2 weeks your doctor might increase your dose if you don’t have any bad side effects.
You have a sample of tissue (biopsy) done between 1 and 4 weeks before starting axitinib. This to find if you able to join the study.
At the same time the team will take 4 extra samples of tissue.
The team will also take an extra blood sample and urine sample:
- before starting axitinib
- every 2 weeks while taking axitinib
- the week of your surgery
- 12 weeks after surgery
They will use these samples and the tissue samples to:
- find out more about kidney cancer
- look for substances (biomarkers) that might show how well axitinib is working
You don’t have to agree to give these extra samples. You can still take part in the main study.
You see the doctor to have some tests before taking part. These tests include:
A week before starting treatment you see the doctor to have:
- a physical examination
- blood tests
- urine test
You see the doctor every 2 weeks during treatment for the same tests.
Everyone has an MRI scan in the 3rd week. People whose cancer hasn’t spread will also have CT scan at this time.
Everyone has a CT scan in the week of surgery.
After surgery you see the doctor at 6 weeks and 12 weeks for:
- a physical examination
- blood tests
- CT scan (at 12 weeks only)
Your doctor will then tell you how often they want to see you after this.
The common side effects of axitinib are:
- flu like symptoms such as headaches, tiredness, aching muscles and joint
- loss of appetite and weight loss
- feeling or being sick
- diarrhoea or constipation
- a change in the amount of hormone the thyroid produces, this could be either an increase or a decrease
- a sore mouth, tongue or throat
- raised blood pressure (hypertension)
- a change in the amount of platelets in your blood, this could be an increase or a decrease with a risk of causing blood clots or bleeding
- shortness of breath and a cough
- tummy (abdominal) pain
- taste changes or loss of taste
- protein in the urine ([proteinuria)
- pain, swelling, redness, peeling skin, blisters, tingling or numbness of hands and, or feet (hand-foot syndrome)
- a decrease in the amount of red blood cells in your blood causing tiredness and breathlessness
- a decreased amount of fluid in the body (dehydration)
- rash or red, dry, itchy skin
- hair thinning
- ringing in the ears (tinnitus)
- minor changes to the way the liver and kidneys work that are unlikely to cause symptoms and will usually go back to normal after finishing treatment
We have more information about axitinib.
Your doctor will talk to you about the side effects before you agree to take part in the study.
How to join a clinical trial
Mr Grant Stewart
Common Services Agency (CSA)
NHS National Services Scotland
Scottish Clinical Trials Research Unit (SCTRU)