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 . 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

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 that has reached your whole body (systemic treatment ), 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 or in situ carcinoma 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 that could affect you taking part
have problems with the digestive system , 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 ) that might tell them how well treatment is working
look for substances made by the cancer (tumour markers )
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:

a physical examination
blood tests
eye tests
CT scan or MRI scan
bone scan
heart trace (ECG )

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:

tiredness, feeling weak and lacking energy (fatigue)
feeling or being sick
diarrhoea or constipation
indigestion
dry, sore or inflamed mouth
a drop in red blood cells causing tiredness and breathlessness
changes to how the liver works
changes to how your kidneys work causing an increase in creatinine in the blood
loss of appetite and changes to taste
dry skin
hair loss
eye problems such as blurred vision, conjunctivitis, dry eye

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.