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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bile duct cancer
Biliary tree cancers
Secondary cancers

Status:

Closed

Phase:

Phase 2

This study is looking at derazantinib for bile duct cancer. It is for cancers that can’t be removed with surgery and has certain changes in the FGFR2 gene Open a glossary item

It is open to people with bile duct cancer that started inside of the liver (intrahepatic bile duct cancer) and has spread.

More about this trial

The FGFR2 gene helps to make a protein called Fibroblast Growth Receptor 2. 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 drug Open a glossary item called a cancer growth blocker. It works by blocking the FGFR2 receptor Open a glossary item. Research shows that derazantinib might help people with intrahepatic bile duct cancer that has certain changes in the FGFR2 gene. 

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

The aims of this study are to find out:

  • how well derazantinib works 
  • more about the side effects
  • how it affects quality of life Open a glossary item

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this study if all of the following apply. You:

  • have bile duct cancer that can’t be removed with surgery and has spread into the surrounding tissue (is locally advanced) or it has spread to another part of the body, or your cancer is a mix of liver cells and bile duct cells  
  • have a cancer that has a certain change in the FGFR2 gene. The study team tests a piece of cancer tissue (biopsy) to find this out, and your doctor can let you know the results.
  • have cancer that got worse after at least 1 course of treatment Open a glossary item that has reached your whole body (systemic treatment Open a glossary item), and there are no suitable treatments available for you
  • have an area of cancer that your doctor can measure on a scan
  • are active but might not be able to do heavy physical work (performance status 0 or 1)
  • have satisfactory blood test results
  • are willing to use contraception during treatment and for a certain time after treatment if there is any chance you or your partner could become pregnant
  • are at least 18 years old

Who can’t take part

Cancer related
You cannot join this study if any of these apply. You:

  • have cancer spread to the brain or spinal cord that is getting worse or needs treatment. You might be able to join if the spread has been treated and is not getting worse. Your doctor will know about this. 
  • have had treatment for your cancer within a certain time before starting the study treatment. Your doctor will know how long for and what types of treatment.
  • have another cancer that is getting worse or needs treatment apart from successfully treated non melanoma skin cancer Open a glossary item or in situ carcinoma Open a glossary item of the cervix

Medical conditions 
You cannot join this study if any of these apply. You:

  • are having major surgery or treatment to the bile duct within 4 weeks of starting treatment
  • have had another treatment that blocks the FGFR2 receptor such as lenvatinib, ponatinib, dovitinib. Your doctor will know if you have had one of these or similar treatments. 
  • have an eye problem or disease that could get worse by having the study treatment. Your doctor will know about this. 
  • are not able to or are unwilling to swallow capsules
  • have problems with your liver that are active or not controlled by medication
  • have had a heart attack within the past 6 months or have any other serious heart problem Open a glossary item that could affect you taking part
  • have problems with the digestive system Open a glossary item, such as Crohn’s disease or ulcerative colitis. These are conditions that could affect how well your body absorbs medication
  • have any other medical condition that isn’t controlled by medication
  • have any other medical condition or mental health problem that your doctor or the study team thinks could affect you taking part
  • have had a blood or albumin transfusion within the 5 days before having the blood sample taken to see if you can take part in the study
  • are allergic to derazantinib or any of its ingredients 

Other

You cannot take part if you are pregnant or breast feeding.

Trial design

This is a phase 2 international study. The team need 143 people with 10 people in the UK to take part. Everyone in the study has derazantinib.

Derazantinib is a capsule. You take 3 capsules once a day every day. You take them at the same time on an empty stomach that is either 1 hour before you eat or 2 hours after. 

Your doctor might reduce the number of capsules or stop them for a short time due to side effects. 

You can expect to take derazantinib for between 1 month and 8 months. 

When you are taking derazantinib you must avoid certain foods, drinks and medications. This includes avoiding herbal and vitamin supplements. Your doctor will tell you about this. 

Quality of life
You fill in a few questionnaires:

  • before starting treatment
  • during treatment
  • at the end of treatment

The questions ask about:

  • your general health
  • side effects and symptoms
  • what you can do

These are quality of life questionnaires. 

Research samples
You give blood samples and urine samples during the study. The team use these to:

  • look for substances (biomarkers Open a glossary item) that might tell them how well treatment is working
  • look for substances made by the cancer (tumour markers Open a glossary item)
  • see what happens to derazantinib in the body
  • see how derazantinib works and its effect on the body

You don’t have to agree to give some of these samples. You can still take part in the study. Your doctor or a member of the study team will tell which ones you must agree to and which ones you don’t have to give.

At the end of your treatment, the team will ask for a sample of tissue (biopsy). You don’t have to agree to this.

Hospital visits

You see the doctor for tests before taking part. These tests include:

You see the doctor regularly while having derazantinib for:

  • blood tests
  • physical examination
  • heart trace

You have a CT scan or MRI scan every 2 months for the first 6 months and then every 3 months after that.

At the end of treatment you see the doctor for the same tests you had at the start. 

A month after finishing treatment and then every 3 months a member of the study team will phone you to see how you are. They also check if you have started other treatment for your cancer.

Side effects

The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 
 
The most common side effects of derazantinib include:

Your doctor or a member of the study team will talk to you about the possible side effects of derazantinib. They do this before you agree to take part.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Jeff Evans

Supported by

Basilea

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17246

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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