An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer
This research study is investigating a new medication called erdafitinib for adults with urothelial cancer, a type of bladder cancer that has spread or cannot be surgically removed. The main goal is to find out how effective erdafitinib is at shrinking or stopping the growth of these cancers, particularly in patients whose cancer cells have specific genetic changes called 'FGFR alterations.' We also want to understand the drug's safety. Participants will know if they are receiving erdafitinib. A special part of the study will also look at how erdafitinib interacts with other common medicines like midazolam (a sedative) and metformin (for diabetes). This is a Phase 2 study, meaning it's still in the earlier stages of drug development.
At a glance
What is this study about?
This study is about a new treatment called erdafitinib for a type of cancer that starts in the bladder or urinary system, known as urothelial cancer. This cancer can sometimes spread to other parts of the body (metastatic) or be difficult to remove with surgery (unresectable).
The main aim of this study is to see how well erdafitinib works in people whose urothelial cancer has a specific genetic change, called an 'FGFR alteration.' This alteration makes the cancer behave in a particular way, and erdafitinib is designed to target this. The study will measure if the drug can shrink the cancer or stop it from growing. Safety is also a key focus – we want to understand any side effects.
The study also includes a small side investigation looking at how erdafitinib interacts with common medicines, specifically midazolam (a drug that can help with relaxation) and metformin (a diabetes medication). This helps doctors understand how to best use erdafitinib with other treatments you might be taking.
Key takeaways
- New drug (erdafitinib) for advanced urothelial cancer with specific genetic changes.
- Aims to check effectiveness and safety.
- Participants will know they are receiving the study drug.
- Includes a look at drug interactions with other common medicines.
- Regular health checks and follow-up are part of the study.
- Participants can leave the study at any time.
Who may be eligible?
To be considered for this study, you must have been diagnosed with urothelial cancer that has spread or can't be removed by surgery. Your cancer should also show specific genetic changes, called 'FGFR genomic alterations'. You would also need to have measurable cancer, meaning doctors can track its size.
Your cancer should have continued to grow despite previous chemotherapy treatment for advanced disease. If you had chemotherapy before surgery or radiotherapy and your cancer came back within a year, you might also be suitable. Your general health and organ function should be good enough to take part.
There are also reasons why you might not be able to join. For example, if you've recently had other cancer treatments, such as chemotherapy or radiation, within the last two weeks, you would likely be excluded. The study team will review all your medical history to decide if this study is right for you.
- Do I have urothelial cancer that has spread or can't be surgically removed?
- Has my cancer shown specific 'FGFR' genetic changes?
- Has my cancer continued to grow despite previous chemotherapy?
- Am I generally well enough to participate in a study?
- Have I avoided other cancer treatments (like chemo or radiation) in the last two weeks?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, everyone will receive the study drug, erdafitinib. You'll know that you're taking erdafitinib, as this is an 'open-label' study. Before treatment starts, you'll have a screening period of about 30 days. This involves tests to confirm you're suitable for the study.
Once treatment begins, you'll take erdafitinib in cycles, which typically last 28 days. You'll continue treatment for as long as it's helping and you're not experiencing severe side effects. Throughout this time, your health will be closely monitored, and you'll have regular hospital visits for assessments and safety checks. For a small number of participants, there will be extra assessments to see how erdafitinib interacts with midazolam and metformin.
After you stop taking the study drug, for whatever reason (e.g., if your cancer progresses or side effects are too much), you'll enter a follow-up phase. This involves ongoing checks until the end of the study, which could be when you pass away, withdraw your consent, or can no longer be contacted, or when the entire study concludes. The total duration of your participation will vary depending on how long you take the drug and the follow-up period.
Potential risks and benefits
Locations (105)
- —Sedona, United States
- —Los Angeles, United States
- —Orange, United States
- —Sacramento, United States
- —Stanford, United States
- —Aurora, United States
- —Washington D.C., United States
- —Chicago, United States
- —Iowa City, United States
- —Louisville, United States
- —Minneapolis, United States
- —Omaha, United States
+93 more sites — see the official record for the full list.
Common questions
What is urothelial cancer?
Urothelial cancer is a type of cancer that starts in the lining of the urinary tract, most commonly in the bladder.
What are 'FGFR genomic alterations'?
These are specific genetic changes within the cancer cells that can make the cancer grow. Erdafitinib is designed to target these specific changes.
What does 'Phase 2' mean?
Phase 2 studies are an important step in drug development. They focus on finding out if a new drug is effective for a specific condition and further checking its safety in a larger group of people than Phase 1.
Will I know if I'm getting the actual study drug?
Yes, this is an 'open-label' study, meaning everyone involved, including you and the study team, will know that you are receiving erdafitinib.
How long will I be in the study?
The length of your participation will depend on how long the drug is helping you and how long the follow-up period needs to be. It will vary for each person.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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