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.
Em resumo
Sobre o que é este estudo?
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.
Pontos principais
- 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.
Quem pode ser elegível?
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.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem 18 anos ou mais?
- 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?
O que envolve a participação?
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.
Riscos e benefícios potenciais
Locations (59)
- University of Alabama at Birmingham - The Kirklin ClinicCódigo postal verificadoBirmingham, Estados Unidos· Recrutamento
- Universidade do Sul da CalifórniaCódigo postal verificadoLos Angeles, Estados Unidos· Recrutamento
- Urology Associates of DenverCódigo postal verificadoLone Tree, United States· Recrutamento
- Urological Research NetworkCódigo postal verificadoHialeah, Estados Unidos· Recrutamento
- Advanced Urology InstituteCódigo postal verificadoLargo, United States· Recrutamento
- Advent Health OrlandoCódigo postal verificadoOrlando, Estados Unidos· Concluído
- Advanced Urology Institute 1Código postal verificadoOxford, United States· Concluído
- H Lee Moffitt Cancer CenterCódigo postal verificadoTampa, Estados Unidos· Recrutamento
- Northwestern UniversityCódigo postal verificadoChicago, Estados Unidos· Recrutamento
- Associated Urological SpecialistsCódigo postal verificadoChicago Ridge, United States· Recrutamento
- Urology of IndianaCódigo postal verificadoGreenwood, United States· Recrutamento
- Urologic Specialists of Northwest IndianaCódigo postal verificadoMerrillville, United States· Recrutamento
Perguntas frequentes
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.
Quanto tempo durará o estudo?
The total time you might be involved in the study, including follow-up, could be up to 7 years and 4 months.
Posso sair do estudo se mudar de ideia?
Yes, you are free to withdraw from the study at any time without it affecting your usual medical care.
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