A trial of brivanib for solid tumours that have spread (CA182026)

Cancer type:

Bladder cancer

Breast cancer

Lung cancer

Non small cell lung cancer

Oesophageal cancer

Ovarian cancer

Pancreatic cancer

Sarcoma

Secondary cancers

Soft tissue sarcoma

Stomach cancer

Transitional cell cancer

Status:

Results

Phase:

Phase 2

This trial looked at brivanib to see if it improved treatment for certain types of solid tumours Open a glossary item .

It was for people whose cancer had spread and they had no standard treatment Open a glossary item options available to them.

A solid tumour is any type of cancer apart from leukaemia, lymphoma or myeloma.

This trial was open for people to join between 2008 and 2011. The team published the results in 2019.

More about this trial

Cancers need a blood supply to help them grow and survive. Growing cancers can grow their own blood vessels. This is called angiogenesis. When this trial was done, researchers were looking at ways to stop cancers being able to grow these new blood vessels. Drugs that block cancer blood vessel growth are called anti angiogenics.

In this trial, researchers looked at an anti angiogenic drug called brivanib. It was a new drug at the time of the trial. Doctors thought it might stop cancer blood vessels growing by blocking 2 growth factors called VEGF and FGF.

The trial was for people who had 1 of the following types of advanced cancer: Open a glossary item

The main aims of the trial were to find out:

if brivanib is safe to have
how well brivanib works for solid tumours
more about the side effects
if brivanib worked better for people who tested positive for a biomarker called FGF2

Summary of results

Trial design
595 people had treatment in this trial. To begin with, everyone had brivanib twice a day, everyday for 12 weeks. Those whose cancer stayed the same (stable) had more treatment. A computer put them into a treatment group at random:

half had brivanib
half had a dummy drug (placebo )

Only those who had soft tissue sarcomas and ovarian cancer were suitable to be put into the more treatment group. People who had other types of cancer didn’t have further treatment as part of this trial.

Soft tissue sarcoma results
76 people who had soft tissue sarcomas took part. Of those, 53 people had soft tissue sarcomas that were positive for the biomarker FGF2.

The team looked at how long it was before their cancer started to grow again. They found this was:

2.8 months for those who had brivanib
1.4 months for those who had the dummy drug

Ovarian cancer results
39 people who had ovarian cancer took part. Of those, 36 people had ovarian cancer that was positive for the biomarker FGF2. The team looked at how long it was before the cancer started to grow again. They found this was:

4 months for those who had brivanib
2 months for those who had the dummy drug

FGF2 biomarker
The team checked if testing positive for the biomarker FGF2 on cancer cells affected how well brivanib worked. They didn’t find that this was the case.

Side effects
The team looked at the side effects for everyone who took part in the trial. Most people had at least one side effect. Some of these were mild or didn’t last long.

Some people who had brivanib had more severe side effects. 423 people (71%) had more severe side effects.

Some of the most common of the more severe side effects included:

fatigue
diarrhoea
feeling or being sick
loss of appetite
high blood pressure
dizziness

Conclusion
The research team suggest that in this small trial, brivanib was safe. It worked for people who had soft tissue sarcomas and ovarian cancer.

They found that testing positive for the FGF2 biomarker didn’t predict how well brivanib would work.

The team say that more research needs to be done to discover exactly how brivanib works.

More detailed information
There is more information about this research in the reference below.

Please note, this article is not in plain English. It has been written for healthcare professionals and researchers.

Phase II randomised discontinuation trial of brivanib in patients with advanced solid tumours
R Jones and others
European Journal of Cancer, 2019. Volume 120, pages 132-139.

Where this information comes from
We have based this summary on the information in the article above. This this has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.