A trial of dovitinib for advanced womb cancer

Cancer type:

Secondary cancers

Womb (uterine or endometrial) cancer

Status:

Results

Phase:

Phase 2

This trial looked at dovitinib for womb (endometrial) cancer that had got worse despite treatment. It was for women who had already had one course of chemotherapy for advanced womb cancer.

More about this trial

One of the treatments for advanced womb cancer is chemotherapy. But the cancer may continue to grow or come back again. So, researchers are looking for ways to help women in this situation. In this trial, they looked at a drug called dovitinib (TKI258).

Dovitinib is a type of targeted cancer drug. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

In about 1 in 10 womb cancers, there is a change to a gene called FGFR2. Researchers wanted to find out whether having a changed FGFR2 gene affected how well dovitinib worked. So, before women joined the trial, the researchers looked at a tissue sample (biopsy Open a glossary item

) of the cancer to see if they had a changed (mutated) or normal gene.

The aims of the trial were to:

see dovitinib helped women with either a normal or a changed FGFR2 gene
learn more about the side effects

Summary of results

The trial team found that having dovitinib as the second treatment for advanced womb cancer worked a bit. But it didn’t work as well as they had hoped. And having the FGFR2 gene change didn’t affect how well treatment worked.

The researchers published these results in 2015.

About this trial

This was a phase 2 trial. 248 women joined and the researchers screened them for FGFR2. Of those:

27 had a change to the FGFR2 gene in their womb cancer cells
221 people had a normal FGFR2 gene

Once the researchers had these results, they put women into treatment groups, and:

22 women with the FGFR2 gene change had dovitinib
31 women with a normal FGFR2 gene had dovitinib

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Everyone had dovitinib tablets for as long as they were working and the cancer didn’t get worse.

Results

The trial team looked at the number of women living whose cancer hadn’t started to grow again. This is called progression free survival. At 18 weeks this was:

7 out of the 22 women (32%) who had the FGFR2 gene change
9 out of the 31 women (29%) who had a normal gene

The average length of time before the cancer started to grow again was:

4.1 months in women who had the gene change
2.7 months in women who didn’t have the gene change

The plan was to do a larger trial with more women. But these results showed that dovitinib hadn’t worked as well as the researchers had hoped. So, the larger trial didn’t go ahead.

Side effects

The most common side effects included:

diarrhoea
feeling or being sick
tiredness (fatigue)
rash

36 women had their dose reduced or interrupted due to side effects.

The more serious side effects included:

a blood clot on the lung
being sick
fluid loss (dehydration)
diarrhoea

Unfortunately, 1 person died from a blood clot on the lung that was linked to taking dovitinib.

Conclusion

The trial team concluded that dovitinib worked a little bit for women with advanced womb cancer. But it didn’t work well enough to be looked at in a larger trial. Having a normal gene or a changed FGFR2 gene didn’t affect how well treatment worked.

This trial has increased knowledge about what works and what doesn’t work for advanced womb cancer.

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.