A study looking at derazantinib for bile duct cancer (FIDES-01)

Cancer type:

Bile duct cancer

Biliary tree cancers

Secondary cancers

Status:

Results

Phase:

Phase 2

This study looked at a drug called derazantinib for bile duct cancer. You pronounce derazantinib as de-ra-zan-ti-nib.

It was for people with bile duct cancer that:

had started inside the liver. This is called intrahepatic bile duct cancer.
had spread
had certain changes in the FGFR2 gene

The study was open for people to join between 2017 and 2022. The team presented the results at a conference in 2022 and put them online in 2023.

More about this trial

The FGFR2 gene helps to make a protein called Fibroblast Growth Receptor 2 (FGFR2 receptor Open a glossary item ). This protein is important for cell growth and the formation of blood vessels. There are changes in this gene in many different cancers including intrahepatic bile duct cancer.

Derazantinib is a targeted cancer drug Open a glossary item called a cancer growth blocker. It works by blocking the FGFR2 receptor. Research showed that derazantinib might help people with intrahepatic bile duct cancer that had certain changes in the FGFR2 gene.

In this study the team looked at a sample of cancer tissue (biopsy Open a glossary item ) to see if the cancer had these changes. Only people with changes in the FGFR2 gene could take part.

Everyone had derazantinib as long as it was working and the side effects weren’t too bad.

The aims of this phase 2 study were to find out:

how well derazantinib works
more about the side effects

Summary of results

147 people took part in this study. There were 2 cohorts or groups. People were put into a group depending on the changes in the FGFR2F gene. So they were either part of sub study one or sub study two.

People had treatment for about 7 months.

Results for sub study one
103 people joined this group.

The team looked at the number of people whose cancer had gone away completely or a little bit. They found this was 23 people (22.3%).

They also looked at whose cancer had gone away completely, a little bit, or stayed the same. They found this was 78 people (75.7%).

The team also looked at how long before the cancer started to grow again. This was about 8 months on average.

Results for sub study two
44 people joined this group.

The team looked at the number of people whose cancer had gone away completely or a little bit. They found this was 4 people (9.1%).

They also looked at whose cancer had gone away completely, a little bit, or stayed the same. They found this was 30 people (68.2%).

The team also looked at how long it was before the cancer started to grow again. They found this was about 8.3 months on average.

Both groups
The team say that derazantinib worked about the same as other treatments for bile duct cancer that had spread.

Side effects
The team say the side effects were manageable. Most people had at least 1 side effect from treatment. They included:

tiredness (fatigue)
feeling sick
dry mouth
diarrhoea
liver changes

Conclusion
The team found that derazantinib worked for some people with bile duct cancer in this small study.

More detailed information
There is more information about this research in the reference below. Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma (FIDES-01)
Clinical Trials.gov. Accessed February 2023.

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