RecruitingOBSERVATIONAL

Fruquintinib in Patients With Metastatic Colorectal Cancer

This study, called FRUQUENT, is happening in Germany and is looking at a medicine called Fruquintinib. It's for people with bowel cancer (colorectal cancer) that has spread to other parts of the body, and who have already tried other common treatments. The main goal is to see how well Fruquintinib works in real-life situations. The research will also check how safe the medicine is, how it affects patients' quality of life, and overall survival. Doctors will treat patients as they normally would. The study also includes extra lab work to help understand which patients might benefit most from Fruquintinib. This involves looking at tumour samples and blood tests to find clues about why the medicine works well for some people and not others.

At a glance

Status

Recruiting

Sponsor

iOMEDICO AG

Enrolment target

150

Start

17 Feb 2025

Estimated completion

01 Dec 2027

Metastatic Colorectal Cancer (mCRC)

What is this study about?

This study, named FRUQUENT, is taking place in Germany and aims to understand how a drug called Fruquintinib works for people living with bowel cancer that has spread (also called metastatic colorectal cancer). It's an 'observational study,' which means doctors will treat patients as they normally would, and then researchers will carefully watch and record how well the treatment works in a real-world setting.

The main idea is to see how effective Fruquintinib is for patients who have already tried other standard treatments for their cancer, such as different types of chemotherapy. The study will look at several important things: how patients respond to the treatment, if it helps them live longer, whether it affects their quality of life, and if there are any side effects. All this information will help doctors understand more about Fruquintinib and who it might help the most.

Doctors participating in the study will make decisions about treatment based on what they usually do and the official guidelines for Fruquintinib. There's also a special part of the study that involves lab tests, like looking at tumour samples and blood, to find specific markers that might show which patients will get the most benefit from Fruquintinib. This helps scientists learn why the treatment works for some people better than others.

Key takeaways

This study helps doctors learn more about Fruquintinib for advanced bowel cancer.
It's for people who have tried other standard cancer treatments.
Your doctor will decide your treatment, not the study.
Information gathered will help future patients.
You must live in Germany and meet specific medical requirements.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. Your doctor must have decided that Fruquintinib is the right treatment for your bowel cancer that has spread, based on the official guidelines in Germany.

You should have already received a number of other standard treatments for your cancer, including certain types of chemotherapy and other specific medicines. Importantly, your cancer must have either gotten worse during treatment with two specific drugs (trifluridine/tipiracil or regorafenib) or you couldn't tolerate those treatments.

Finally, you can't be taking part in another medical study that involves receiving a new treatment within 30 days before starting Fruquintinib or joining this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Has your doctor decided Fruquintinib is the right treatment for your spreading bowel cancer?
Have you already received other standard treatments for your cancer?
Has your cancer progressed on, or were you unable to tolerate, trifluridine/tipiracil or regorafenib?
Are you currently not taking part in another strong medical trial for a new treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given specific instructions on how to use Fruquintinib; your doctor will treat you as they normally would, following standard medical practice. The study simply collects information about your treatment, results, and experiences while you are receiving Fruquintinib.

Researchers will gather routine clinical data, such as how your cancer responds to the treatment, any side effects you might have, and how it affects your daily life. They may also collect blood and tumour tissue samples (if available from previous procedures) to help them understand why Fruquintinib works differently for different people. All data is collected from your usual medical appointments; you won't have extra visits just for the study. The total duration of your participation will depend on how long you receive Fruquintinib, as decided by your doctor.

Potential risks and benefits

Taking part in this study means that information about your treatment will be carefully collected, which can help other patients in the future. You will receive Fruquintinib as prescribed by your doctor, and this study does not change your treatment plan. The main benefit to you is contributing to medical knowledge. As with any medication, Fruquintinib may cause side effects, which your doctor will discuss with you. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Onkologische Schwerpunktpraxis
Verified postcode
Hanover, Germany· Recruiting

Common questions

What kind of cancer is this study for?

This study is for people with bowel cancer (colorectal cancer) that has spread to other parts of the body.

What is Fruquintinib?

Fruquintinib is a medicine being studied to treat bowel cancer that has spread, especially for people who have already tried other treatments.

Do I have to live in Germany to take part?

Yes, this specific study, FRUQUENT, is only taking place in Germany.

Will my treatment change if I join this study?

No, your doctor will continue to treat you as they normally would. The study simply collects information about your treatment.

What does 'observational study' mean?

It means the researchers are watching and recording what happens during your normal treatment, rather than telling your doctor what to do.

How to find out more

Max D Mai, MSc

fruquent@iomedico.com +49 761 152420 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.