A trial of GSK1070916A for advanced cancer

Cancer type:

All cancer types

Status:

Results

Phase:

Phase 1

This trial looked at a drug called GSK1070916A for solid tumours that have continued to grow despite all standard treatment. This trial was supported by Cancer Research UK.

A solid tumour is a cancer that has developed in a body organ or tissue. It does not include cancers of the blood system or lymphatic system such as a leukaemia or lymphoma.

Sometimes cancers continue to grow even if you have had all the standard treatments available. Researchers are looking for new drugs to help people in this situation. In this trial, they looked at a drug called GSK1070916A.

GSK1070916A targets a protein in cells called aurora kinase B, which helps cells divide and grow.  GSK1070916A works by slowing down or stopping the activity of aurora kinase B. The researchers hoped that this would stop the cancer growing.

The aims of the trial were to

  • Find the best dose of GSK1070916A to use
  • See what happens to the drug in the body
  • Learn more about the side effects
  • See if GSK1070916A helps people with advanced solid tumours

Summary of results

The research team found the best dose of GSK1070916A to give, and found that it was safe to use.

This trial recruited 39 people with advanced cancer. They had already had all the standard treatments available for their type of cancer.

The first person who took part in this trial had the lowest dose of GSK1070916A. As they didn’t have any serious side effects, the next person had a higher dose. The research team did this until they found the best dose to use. For some dose levels more than one person had the same dose. The people who had the highest dose had some serious side effects. So the research team decided that a lower one would be the best one to use. This is called a dose escalation study.

Everyone taking part had at least 1 side effect, and some of them were classed as serious. The most common side effect was a drop in white and red blood cells, which caused an increased risk of infection, tiredness and breathlessness. Other side effects included tummy (abdominal) pain, feeling or being sick and diarrhoea.

The research team were able to look at how well the treatment worked for 36 of those who took part. They found that the cancer

  • Got smaller in one person
  • Stayed the same in 21 people
  • Continued to grow in 14 people

The research team also looked at how GSK1070916A affected certain proteins in blood and urine samples. They found that the levels of the proteins changed in some people, but not in others. There was no consistent pattern in the results. They looked at one protein in a sample of cancer cells from 4 people who took part. They found that the level dropped in 3 out of these 4 people, showing that the treatment was having an effect on the cancer cells.

The research team concluded that they had found the best dose of GSK1070916A to use, that it was safe to use and that it had some effect on cancer cells.

We have based this summary on information from the team who ran the trial.  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 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 CJ Twelves
Professor Iain McNeish

Supported by

Cancer Research UK (Centre for Drug Development)
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)

Other information

This is Cancer Research UK trial number CRUKD/10/029.

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 - 4479

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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