RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

This research study is looking at a new treatment for bladder cancer, called Erdafitinib, which is delivered directly into the bladder using a special system. Bladder cancer is often treated with regular check-ups and surgery, but this study hopes to find a new, effective approach. The study is split into several parts: initially, researchers will work out the safest and most effective dose of the drug. Later parts will then confirm its safety and see how well it helps control the cancer, especially in people with milder forms of bladder cancer that only affect the bladder's inner lining. The drug, Erdafitinib, targets specific changes in cancer cells (called FGFR mutations) and aims to treat the cancer locally while reducing serious side effects elsewhere in the body.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

235

Start

11 Apr 2022

Estimated completion

24 Jul 2029

Non-Muscle Invasive Bladder Neoplasms

What is this study about?

This study is investigating a new treatment for bladder cancer. Bladder cancer can be quite common, and often requires frequent monitoring and sometimes surgery to remove cancerous growths from the bladder lining. This new treatment uses a drug called Erdafitinib, which targets specific changes found in some cancer cells. Instead of giving Erdafitinib as a tablet that affects the whole body, this study is testing a special way to deliver the drug directly into the bladder. This is designed to treat the cancer where it is, while hopefully causing fewer side effects in other parts of the body.

The study has a few different stages. In the first stages, the main goal is to find the best and safest dose of this new bladder delivery system. Once that's established, later stages will check if this dose works well against the cancer and confirm its safety over time. Ultimately, the researchers want to see if this treatment can lead to a complete response, meaning the cancer disappears, particularly for a type of bladder cancer called non-muscle invasive bladder cancer, where the cancer cells are only in the inner lining of the bladder.

Taking part in this study could last for quite a long time, up to 7 years and 4 months, involving an initial screening, the treatment itself, and then a follow-up period to monitor your health. The aim is to find a less invasive and more targeted way to treat bladder cancer for suitable patients.

Key takeaways

This study is testing a new way to deliver bladder cancer medication.
The drug, Erdafitinib, targets specific changes in cancer cells.
It aims to treat cancer locally in the bladder, hopefully reducing body-wide side effects.
The study has different stages to find the best dose and check how well it works.
Participation could last several years, including treatment and follow-up.

Who may be eligible?

This study is looking for adults aged 18 or older with specific types of bladder cancer. For many parts of the study, you would need to have changes in your cancer cells (called FGFR mutations or fusions) that the drug Erdafitinib targets. These changes will be checked using samples from your cancer.

Some parts of the study are for people whose cancer affects the inner lining of the bladder and who have either had a previous treatment called BCG or couldn't get it. There are also specific rules about previous treatments you might have had, for example, you shouldn't have had a similar drug before, or radiotherapy to your pelvis within the last 6 months. It's important that your overall health is good enough to take part. For some, a specific type of less serious bladder cancer (IR-NMIBC) is required.

There are also reasons why you might not be able to join. For example, if you have cancer similar to bladder cancer in other parts of your urinary system (like the urethra or kidney), or if you've had certain other treatments recently. Researchers will carefully check all these details to make sure the study is right for you and safe.

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?
Do you have a type of bladder cancer with specific cell changes (FGFR mutations)?
Have you not had a similar FGFR-targeting drug previously?
Have you not had pelvic radiotherapy in the last 6 months?
Are you able to provide tissue and urine samples for testing?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it generally involves three main phases. First, there's a "screening phase" where doctors will do tests to confirm you're suitable for the study. Then, if you qualify, you'll enter the "treatment phase," where you will receive the Erdafitinib drug directly into your bladder using the special delivery system. The doctors will closely monitor how you respond to the treatment and for any side effects. After the treatment period, there will be a "follow-up phase" where doctors will continue to check on your health and the progress of your cancer. The total time you could be involved in the study, from start to finish, might be quite long, up to 7 years and 4 months.

Potential risks and benefits

Participating in a clinical trial offers the chance to access a new treatment that isn't widely available yet, which might be helpful if standard treatments haven't worked or aren't suitable. However, new treatments can have unknown side effects, and this particular treatment is still being tested for its safety and effectiveness. While this drug aims to reduce side effects by staying in the bladder, general side effects could still occur. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your future medical care.

Locations (59)

University of Alabama at Birmingham - The Kirklin Clinic
Verified postcode
Birmingham, United States· Recruiting
University of Southern California
Verified postcode
Los Angeles, United States· Recruiting
Urology Associates of Denver
Verified postcode
Lone Tree, United States· Recruiting
Urological Research Network
Verified postcode
Hialeah, United States· Recruiting
Advanced Urology Institute
Verified postcode
Largo, United States· Recruiting
Advent Health Orlando
Verified postcode
Orlando, United States· Completed
Advanced Urology Institute 1
Verified postcode
Oxford, United States· Completed
H Lee Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
Northwestern University
Verified postcode
Chicago, United States· Recruiting
Associated Urological Specialists
Verified postcode
Chicago Ridge, United States· Recruiting
Urology of Indiana
Verified postcode
Greenwood, United States· Recruiting
Urologic Specialists of Northwest Indiana
Verified postcode
Merrillville, United States· Recruiting

Common questions

What is Erdafitinib?

Erdafitinib is a drug that targets specific changes in cancer cells (called FGFR mutations) to stop them from growing.

Why is it delivered into the bladder?

Delivering the drug directly into the bladder aims to treat the cancer where it is, potentially reducing side effects in other parts of your body.

What does 'non-muscle invasive bladder cancer' mean?

This means the cancer cells are only in the inner lining of the bladder and have not spread deeper into the bladder muscle.

How long will the study last?

The total time you might be involved in the study, including follow-up, could be up to 7 years and 4 months.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time without it affecting your usual medical care.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

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