A study of axitinib for kidney cancer (NAXIVA)

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.

Cancer related
You:

• 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

Medical conditions
You:

• 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)

Other
You:

• 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