A study looking at AZD4547 for stomach, oesophageal or breast cancer with extra copies of an FGFR gene (FGFR study)

Cancer type:

All cancer types

Status:

Results

Phase:

Phase 2

This study looked at a drug called AZD4547 for oesophageal (food pipe), stomach or breast cancer that has extra copies of the FGFR gene.

It was open for people to join between 2012 and 2017, and the team first published results in 2016.

More about this trial

This study looked at a drug called AZD4547 for:

cancer of the lower oesophagus (food pipe)
stomach cancer (gastric cancer)
cancer at the point where the oesophagus and stomach meet (gastro oesophageal junction cancer)
breast cancer

It was for people whose cancer cells had extra copies of a gene called FGFR1 or FGFR2. This is called gene amplification.

AZD4547 is a type of targeted treatment called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The aims of this study were to find out:

how well AZD4547 works for people whose cancers have extra copies of the FGFR1 or FGFR2 gene
more about the side effects

Summary of results

The research team found that AZD4547 could be useful for people with stomach or oesophageal cancer that has extra copies of the FGFR2 gene.

Study design
The people taking part in this study all had advanced cancer. They’d already had treatment, but their cancer had continued to grow.

Everyone taking part took AZD4547 tablets. They had scans and blood tests before and during treatment, so the research team could assess how well the treatment worked.

Results
The research team assessed 341 people to see if they were eligible to join this study.

Nearly 2 out of 10 people (18%) with breast cancer had extra copies of the FGFR1 gene. And 8 of these went on to have AZD4547 treatment.

12 out of 138 people (9%) with oesophageal cancer or stomach cancer had extra copies of the FGFR2 gene. And 9 people went on to have AZD4547 treatment.

The research team looked at how well the treatment worked. They found that the cancer got a bit smaller in:

1 out of 8 people (13%) with breast cancer
3 out of 9 (33%) people with oesophageal or stomach cancer

They found that AZD4547 worked better in people who had a larger number of extra copies of the FGFR gene.

They looked at how long it was before the cancer started growing again. It was between 6 and 10 months.

Blood test
The research team took blood samples to look for specific proteins (biomarkers) which they hoped would show who had extra copies of an FGFR gene.

They found that the blood test detected the extra genes in everyone who responded to treatment. They hope to develop this test further so they can use it to find out who has extra copies of these genes.

Side effects
The most common side effects were:

extreme tiredness (fatigue)
constipation
sore mouth (mucositis)
skin changes
problems with the back of the eye (retina)

Conclusion
The research team concluded that AZD4547 may be useful for people with advanced oesophageal or stomach cancer and a change in the FGFR2 gene.
And they think they have found a blood test which could be used to screen for people with extra copies of an FGFR gene.

Where this information comes from
We have based this summary on information from the research team. 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 who did the research. We have not analysed the data ourselves.