
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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 .
It is open to people with bile duct cancer that started inside of the liver (intrahepatic bile duct cancer) and has spread.
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 called a cancer growth blocker. It works by blocking the FGFR2
. 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 () 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:
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:
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot take part if you are pregnant or breast feeding.
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:
The questions ask about:
These are quality of life questionnaires.
Research samples
You give blood samples and urine samples during the study. The team use these to:
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.
You see the doctor for tests before taking part. These tests include:
You see the doctor regularly while having derazantinib for:
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.
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Jeff Evans
Basilea
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”