A trial looking at GSK461364 for advanced cancer

Cancer type:

All cancer types

Status:

Results

Phase:

Phase 1

This trial was looking at a new drug called GSK461364 for people with advanced cancer Open a glossary item .

Cancer grows because cancer cells can keep multiplying out of control. A number of proteins (enzymes Open a glossary item ) are involved when cells divide. One of these enzymes is called PLK1. In some types of cancer cells, there are very large amounts of PLK1

GSK461364 is a new drug that can stop PLK1 working. If the PLK1 doesn’t work, the cells won’t be able to divide and the cancer will stop growing. GSK461364 is one of a group of drugs called kinase inhibitors.

We knew from laboratory research that GSK461364 could stop or slow down the growth of many different types of cancer cells. But this drug had not been tested in people and the researchers didn’t know how well it would work.

This trial was looking at GSK461364 for advanced cancer that had continued to grow despite treatment. The aims of the trial were to find out

The best dose of GSK461364 to give
What happens to GSK461364 in the body
What the side effects are
How well it works for advanced cancer

Summary of results

The researchers found the highest doses of GSK461364 they could safely give and learnt more about the side effects.

The trial recruited 40 people who had an advanced solid tumour that had got worse or come back despite having other treatment. Everybody taking part had GSK461364 in 4 week cycles of treatment. But there were 2 different ways of having the drug.

23 people had GSK461364 through a drip into a vein once a week for 3 weeks out of 4
17 people had GSK461364 twice a week for 3 weeks out of 4

The first few people in each group had a low dose of GSK461364. If they didn’t have any serious side effects, the next few people had a higher dose. And so on, until the researchers found the best dose to give. This is called a dose escalation study.

In this trial, the researchers found the highest dose of GSK461364 you can safely have once a week, and the highest safe dose if you have it twice a week. By taking a number of blood samples, they learnt more about what happens to the drug in the body – this is called pharmacokinetics Open a glossary item .

The trial team also looked at how well GSK461364 worked for advanced cancer. The best response they found was that in 6 people, the cancer had not got any bigger or smaller – researchers call this stable disease Open a glossary item .

The most common serious side effects were

A drop in the number blood cells causing problems such as an increased risk of infection, bleeding problems, tiredness and breathlessness
Blood clots

In the group of people having GSK461364 twice a week, 5 had a blood clot in the lung.

The researchers suggest that if there are further trials of GSK461364, it would be best to give it once a week and to have a drug to prevent blood clots (an anticoagulant) at the same time.

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.