A trial comparing dovitinib with sorafenib in kidney cancer

Cancer type:

Kidney cancer
Renal cell cancer

Status:

Results

Phase:

Phase 3

This trial compared a new drug called dovitinib (pronounced dove-it-in-ib) with sorafenib in people with kidney cancer. The trial was for people with a type of kidney cancer called renal cell cancer that had come back after treatment (recurred). Dovitinib is also called TKI258.

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.

Both sorafenib and dovitinib are biological therapies known as cancer growth blockers. They stop signals that cancer cells use to divide and grow.

The aims of this study were

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

Summary of results

The trial team found that dovitinib was no better that sorafenib to treat kidney cancer that had come back after previous treatments.

This was a phase 3 trial. It was a randomised trial and recruited 570 people. They were put into 1 of 2 treatment groups and neither they nor their doctor chose which group they were in.

  • 284 people had dovitinib
  • 286 people had sorafenib

After a follow up of just over 11 months, the researchers looked at the average time it took for the cancer to get worse. They found that for both groups it was about 3½ months.

When the researchers looked at the average overall time people lived, they found it was about 11 months for both groups.

The most common serious side effects of dovitinib were

  • Increase in the level of certain type of fat (triglyceride) in the blood
  • Tiredness (fatigue)
  • High blood pressure
  • Diarrhoea

The most common serious side effects of sorafenib were

  • High blood pressure
  • Tiredness (fatigue)
  • Shortness of breath
  • Numbness, tingling and pain in the hands and feet

The trial team concluded that dovitinib did work for people with kidney cancer that had come back after previous treatment, but it wasn’t any better than sorafenib.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial 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 Paul Nathan

Supported by

Novartis
NIHR Clinical Research Network: Cancer

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9114

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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