A trial of brivanib for solid tumours that have spread (CA182026)
Cancer type:
Status:
Phase:
This trial looked at brivanib to see if it improved treatment for certain types of
It was for people whose cancer had spread and they had no
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
- soft tissue sarcomas
- ovarian cancer
- breast cancer
- pancreatic cancer
- non small cell lung cancer
- stomach cancer
- oesophageal cancer
- transitional cell cancer
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 (
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.
Chief Investigator
Professor Stan Kaye
Supported by
Bristol-Myers Squibb
Experimental Cancer Medicine Centre (ECMC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040