Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of selumetinib with chemotherapy for advanced biliary tract cancers (ABC 04)
This trial looked at a drug called selumetinib with chemotherapy for cancer of the bile duct or gallbladder (the biliary tract). Cancer Research UK supported this trial.
More about this trial
Bile duct cancers and gallbladder cancer are known as biliary tract cancers. It is called advanced biliary tract cancer if
- it can’t be removed by surgery
- it comes back after surgery
- it spreads to another part of the body
Chemotherapy is used to treat advanced biliary tract cancer. Cisplatin and gemcitabine are the 2 drugs most often used.
Selumetinib is a type of biological therapy called a
The aims of this study were to
- find the best dose of selumetinib to have with chemotherapy for advanced biliary tract cancer
- learn more about the side effects
Summary of results
The team found the best dose of selumetinib to give with cisplatin and gemcitabine for biliary tract cancers.
This was a phase 1 trial.
At the start 3 people had 75mg of selumetinib with their chemotherapy. As they didn’t have any serious side effects another 3 people were started on this dose. This continued until 12 people had this dose of selumetinib with chemotherapy.
Of the 12 people only 1 person had a side effect serious enough to stop selumetinib or reduce the dose. The side effect was chest pain.
Other side effects included
- a drop in blood cells causing an increased risk of infection, bruising and bleeding
- feeling or being sick
- constipation or diarrhoea
- a change to how the liver works
The trial team concluded that 75mg of selumetinib twice a day was the best dose to give.
Other studies are now being done. These are to find substances in the body (biomarkers) that could be used to predict how well people might respond to this combination of treatment.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (
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.
Dr John Bridgewater
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
This is Cancer Research UK trial number CRUKE/10/036