A trial comparing TKI258 with sorafenib in kidney cancer

This trial is comparing a new drug called TKI258 with sorafenib in people with a type of kidney cancer called clear cell cancer. The trial is for people who have cancer that has come back after treatment (recurred).

Doctors usually treat kidney cancer that has spread (metastatic renal cell cancer) with biological therapies. But sometimes the cancer starts to grow again. When this happens it is often more difficult to treat and researchers are looking for new treatments to help people in this situation.

Like sorafenib, TKI258 is a type of drug known as a tyrosine kinase inhibitor (TKI for short). TKI’s block tyrosine kinase which is a chemical messenger (an enzyme) that sends messages to tell cells to divide and grow. Blocking the effect of tyrosine kinase may stop cancer cells growing.

The aims of this study are

To find out if TKI258 is better than sorafenib to treat kidney cancer that has come back
To look at the side effects

Recruitment

Start 01/03/2011

End 30/11/2012

Phase

Phase 3

Who can enter

You may be able to enter this trial if you

Have clear cell kidney cancer
Have already had treatment with 2 different types of biological therapy that did not include sorafenib
Have cancer that has got worse while you were taking biological therapy, or within 6 months of stopping
Have cancer that can be measured on CT scan or MRI scan
Have satisfactory blood test results
Are well enough to be up and about for at least half the day (Karnofsky performance status of more than 70 %)
Are willing to use reliable contraception while you are taking trial medication and for 8 weeks after if there is any chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have had sorafenib before
Have had TKI258 before
Have kidney cancer that has spread to the brain
Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least 3 years ago
Have had biological therapy in the last 2 weeks
Still have side effects from any previous treatment
Have had nitrosurea or mitomycin C in the last 6 weeks
Have had a monoclonal antibody, immunotherapy or chemotherapy in the last 4 weeks
Have had radiotherapy in the last 4 weeks
Have had radiotherapy for symptom control in the last 2 weeks
Have had major surgery in the last 4 weeks
Have had a blood clot in the last 6 months
Have any heart problems that are a cause for concern
Have raised blood pressure that is not controlled by tablets
Are unable to absorb tablets
Are known to be HIV positive
Are known to have problems with your liver that are a cause for concern
Are having treatment to thin your blood (anti coagulants)
Have any other medical condition that may interfere with the results of the study
Are pregnant or breastfeeding

Trial design

This trial aims to recruit 550 people from around the world.

This is a randomised trial. The people taking part are put into treatment groups by computer. Neither you nor your doctor will be able to decide which group you are in.

Group 1 will have sorafenib tablets every day.

Group 2 will have TKI258 tablets every day for 5 days then 2 days off.

You continue to take the tablets until your cancer starts to grow again.

You will be asked to fill out a questionnaire before you start treatment and then at most visits to hospital. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you had surgery to remove your cancer. They will also ask you for a blood sample. These samples will be used to find out more about kidney cancer and how to treat it in the future. If you do not want to give tissue or blood samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include

Physical examination
Blood tests
Urine test
Heart ultrasound (echocardiogram) or MUGA scan
Heart trace (ECG)
CT scan or MRI scan
Bone scan or X-rays of your arms and legs (long bones), spine, pelvis and skull (skeletal survey)