RecruitingPHASE2INTERVENTIONAL

Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells

This study is testing a new use for a cancer drug named pemigatinib. This drug works by targeting a specific genetic change, or 'alteration,' in a gene called FGFR, which can be found in various solid tumours like those in the bile ducts, bladder, and lung. Pemigatinib is already approved for some bile duct cancers. This trial wants to find out if it can also help people with other types of solid cancers that have this FGFR alteration, especially if their cancer has come back or spread. Participants will take pemigatinib by mouth for two weeks, followed by a one-week break, repeating this cycle as long as it benefits them. The study will monitor their progress closely through regular clinic visits and tests.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

UNICANCER

Enrolment target

Start

27 Mar 2025

Estimated completion

30 Jun 2028

Solid Tumor, Miscellaneous

What is this study about?

This study is about a kind of cancer treatment called pemigatinib. Cancers can sometimes have changes, also known as 'alterations,' in their genes. One of these genes is called FGFR. When the FGFR gene has a specific alteration, it can play a role in how the cancer grows. These FGFR alterations can be found in many different types of solid cancers, such as those that affect the bile ducts, bladder, womb, brain, ovaries, lungs, and digestive system, although they are not common in every cancer.

Pemigatinib is a medication designed to target cancer cells that have these specific FGFR alterations. It's already used in the UK and Europe to treat certain cancers of the bile ducts that have this genetic change. However, earlier studies have hinted that pemigatinib could be helpful for other kinds of cancer too, as long as they also have this FGFR alteration. This trial is specifically designed to explore this potential.

The main goal of this study is to discover if pemigatinib can effectively treat people with various solid cancers that have the FGFR gene alteration, particularly if their cancer has returned or spread to other parts of the body. It will not include blood cancers or types of cancer for which pemigatinib is already a standard treatment. Basically, if your cancer has this specific gene alteration, this study wants to see if pemigatinib can help shrink the tumour, stop it from growing, or even make it disappear.

Key takeaways

This study tests pemigatinib for solid cancers with an FGFR gene alteration.
Pemigatinib targets a specific genetic change in cancer cells.
It's for people whose cancer has returned or spread, excluding blood cancers.
You'll take the drug by mouth in cycles and have regular check-ups.
The aim is to see if the drug can control or shrink the cancer.
Participation involves potential benefits but also risks of side effects and clinic visits.

Who may be eligible?

To join this study, doctors will first need to confirm that you have a solid tumour. This cancer must have a specific change in the FGFR gene (either FGFR1, 2, or 3). Your cancer also needs to be locally advanced (meaning it can’t be fully removed with surgery), has come back, or has spread to other parts of your body. You must be at least 18 years old, and your doctor needs to believe that this type of treatment is suitable for you because other standard treatments haven't worked or aren't available.

You'll need to be in reasonably good general health, meaning you can mostly look after yourself. Doctors will also check that your liver, kidney, blood, and other body functions are working well enough for you to take the medication safely. You should also have an estimated life expectancy of more than three months.

Finally, for doctors to properly measure if the treatment is working, your cancer needs to be measurable on scans. You'll also need to have had two recent scans (within a three-month period, at least four weeks apart) that show your cancer has been growing during that time, without any cancer treatment given during that period.

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.

Do I have a solid cancer that doctors can measure on a scan?
Has my doctor confirmed that my cancer has a specific FGFR gene alteration?
Am I at least 18 years old?
Is my general health good enough to manage clinic visits and treatment?
Do my recent scans show that my cancer has been growing and I haven't received other cancer treatments during that scan period?
Are my liver, kidney, and blood tests within the acceptable range for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive pemigatinib by mouth. You’ll take the drug every day for two weeks, followed by a one-week break, and then the cycle repeats. You’ll continue this treatment for as long as it is helping you. Your progress will be closely monitored through regular visits to the clinic.

During your treatment, you will typically visit the clinic every three weeks for check-ups and tests. After you finish taking pemigatinib, you'll continue with follow-up appointments, usually once every three months, for at least 12 months, to make sure you're doing well and to check for any long-term effects.

Potential risks and benefits

The potential benefit of taking part in this study is that pemigatinib might help control your cancer, possibly by shrinking it, stopping it from growing, or even making it disappear, which could also help with related symptoms. However, like all medications, pemigatinib can cause side effects. These risks are mainly related to the drug's possible adverse effects. The study involves regular clinic visits, blood tests, eye tests, and scans (like X-rays), which can be time-consuming, but these are important for your safety and to closely monitor how you are responding to the treatment. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

CHU de BREST
Verified postcode
Brest, France· Recruiting
Centre Antoine Lacassagne
Verified postcode
Nice, France· Active not recruiting
Institut Curie
Verified postcode
Paris, France· Not yet recruiting
CHU Poitiers
Verified postcode
Poitiers, France· Active not recruiting
CHU Saint Etienne
Verified postcode
Saint-Priest-en-Jarez, France· Active not recruiting
Institut de Cancerologie de Lorraine
Verified postcode
Vandœuvre-lès-Nancy, France· Active not recruiting

Common questions

What is an FGFR gene alteration?

It's a specific change in a gene called FGFR that can sometimes make cancer cells grow. This drug aims to target those altered cells.

Is pemigatinib already used for cancer?

Yes, it's approved in the UK for some bile duct cancers with this specific FGFR alteration. This study is exploring its use in other types of cancer.

Will I get other treatments alongside pemigatinib?

No, in this study, all participants will receive pemigatinib on its own to see how well it works for their type of cancer.

How long will I take the drug for?

You will take the drug in cycles (2 weeks on, 1 week off) for as long as it is helping you and until your doctor decides it's no longer beneficial.

What are the main tests I'll have?

You'll have regular blood tests, eye checks, and scans (like CT or MRI) to see how the treatment is working and monitor for any side effects.

How to find out more

Céline MAHIER AIT OUKHATAR

c-mahier@unicancer.fr +33 (0)6 17 51 34 29 Official trial record

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