A trial looking at axitinib for the treatment of advanced kidney cancer (A-PREDICT)

Cancer type:

Kidney cancer
Renal cell cancer

Status:

Results

Phase:

Phase 2

This trial looked at a drug called axitinib (Inlyta) for people with kidney cancer (renal cell cancer) that had spread to another part of the body (advanced).

This trial was supported by Cancer Research UK.

More about this trial

The main treatment for kidney cancer is usually surgery to remove the kidney. But surgery isn’t always possible if the cancer is advanced and has spread to other parts of the body. For people with advanced kidney cancer who can’t have surgery, a possible treatment is a targeted cancer drug. A drug called temsirolimus (Torisel) was often used at the time this trial was done.

In the A-PREDICT trial, people with advanced kidney cancer who couldn’t have surgery had treatment with a new targeted cancer drug called axitinib. Everyone who took part was having treatment for their cancer for the 1st time.

Axitinib is a type of targeted cancer drug called a tyrosine kinase inhibitor (TKI). Axitinib has been found to stop or slow the growth of new blood vessels. New blood vessels supply the cancer with the nutrients it needs to grow. By preventing the growth of blood vessels, axitinib can stop or slow the cancer from growing and spreading.

The main aims of this trial were to:

  • find out how many people were alive and did not have growth in their cancer after 6 months of axitinib treatment
  • find out how long people lived after starting axitinib treatment
  • learn more about the side effects of axitinib treatment
  • find out if people could have surgery to remove their kidney after having axitinib treatment

Summary of results

This was a phase 2 trial. 65 people with advanced kidney cancer who couldn’t have surgery to remove their kidney took part. The main reason why people couldn’t have surgery was because their cancer had spread in and around their kidneys or to other parts of their body.

Everyone in this trial took axitinib tablets, twice every day. People took axitinib until either their cancer started to get worse (disease progression) or they had severe side effects.

The trial team looked at how well axitinib worked. To do this, they looked at the number of people who were alive and with no signs of their cancer getting worse, after 6 months of taking axitinib. They found 39 out of 65 people (60%) were alive and did not have any disease progression after 6 months of treatment with axitinib.

The trial team also looked at the length of time people lived without their cancer getting worse. This is called progression free survival. They found on average it was around 8 and half months.

The team looked at the amount of time people lived after the start of axitinib. This is called overall survival. They found on average it was around 19 months.

The trial team also found that 8 out of 65 people (12%) were able to have surgery to remove their kidney after having axitinib treatment.

The trial team looked at the most severe side effects people had. They were high blood pressure and tiredness (fatigue). Doctors were able to treat these side effects.

So, the team concluded that axitinib helps people with advanced kidney cancer who can’t have surgery. They also found that this treatment is safe to take.

This was a phase 2 trial which did not compare axitinib with another treatment. So, more research will need to be done to confirm the results of this trial.  

Since the A-PREDICT trial began, new treatments including immunotherapy drugs have become available for people with advanced kidney cancer.

We have based this summary on information from the research team.  As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item) or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr James Larkin

Supported by

The Institute of Cancer Research (ICR)
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Pfizer
The Royal Marsden NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUKE/11/061.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

8285

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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