A trial of everolimus for advanced stomach cancer (GRANITE-1)

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Cancer type:

Stomach cancer

Status:

Results

Phase:

Phase 3

This trial looked at everolimus for cancer of the stomach that has continued to grow despite chemotherapy or has come back after treatment.

Doctors may use chemotherapy to treat advanced stomach cancer (gastric cancer). But sometimes the cancer continues to grow, or comes back later on.

In this trial, they looked at a drug called everolimus to see if it can help people in this situation.

Everolimus is a type of biological therapy. It is also known as RAD 001 or Afinitor. It was first developed for people who have had a heart or kidney transplant. It helps to stop the body rejecting the new organ. But we know from research that everolimus may also help to stop cancer cells growing.

The aim of this trial was to see if everolimus helps people with advanced stomach cancer.

Summary of results

The trial team found that everolimus did not help people with advanced stomach cancer that had continued to grow or had come back after chemotherapy.

This trial recruited 656 people from 23 countries. The people taking part were put into 1 of 2 treatment groups at random. They either had everolimus or a dummy drug (placebo). Everyone taking part also had treatment they needed for their specific symptoms. Doctors often call this best supportive care.

For every 2 people who had everolimus, 1 person had the dummy drug. So

  • 439 people had best supportive care and everolimus
  • 217 people had best supportive care and the dummy drug

The research team looked at how long it was on average before the cancer started to grow again. They found it was

  • 1.7 months for those who had everolimus
  • 1.4 months for those who had the dummy drug

They also looked at how long on average people in each group lived for, and found it was

  • 5.4 months for those who had everolimus
  • 4.3 months for those who had the dummy drug

There is a small difference between the 2 groups, but it could have happened by chance. The results were not statistically significant Open a glossary item.

Nearly everyone taking part had at least one side effect. The most common side effects were loss of appetite, sore mouth, tiredness (fatigue) and feeling sick.

The research team concluded that everolimus did not help people with advanced stomach cancer who had already had chemotherapy.

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

Professor David Cunningham

Supported by

NIHR Clinical Research Network: Cancer
Novartis

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Last review date

CRUK internal database number:

Oracle 5643

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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