Study on Erdafitinib Bladder Delivery System for Localized Bladder Cancer
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT05316155
This clinical trial is testing a new way to deliver the drug Erdafitinib directly into the bladder to treat localized bladder cancer. The study aims to find the best dose and evaluate how well it works in patients with non-muscle invasive bladder cancer.
Patient Parameters
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Program Overview
The study is exploring a new treatment method for bladder cancer using Erdafitinib, a drug that targets specific genetic changes in cancer cells. The treatment involves delivering Erdafitinib directly into the bladder to target cancer cells while minimizing side effects. The study will be conducted in several parts to determine the best dose and assess the treatment's effectiveness and safety in patients with non-muscle invasive bladder cancer.
Description
Bladder cancer is a common type of cancer that often requires frequent monitoring and surgery to remove tumors. This study is for patients with bladder cancer that has not spread into the muscle layer of the bladder. The study focuses on patients whose cancer cells have specific genetic changes called FGFR mutations or fusions. Erdafitinib is a drug that blocks these changes and has shown promise in treating bladder cancer when taken by mouth. This study tests a new way of delivering Erdafitinib directly into the bladder to treat the cancer locally and reduce side effects. The study includes a screening phase to determine eligibility, a treatment phase where participants receive the drug, and a follow-up phase to monitor results. The entire study will last nearly six years.
Eligibility Criteria
Inclusion Criteria
Parts 1-3:
- Have muscle-invasive or recurrent non-muscle-invasive bladder cancer.
- Have specific genetic changes in the cancer cells, confirmed by approved tests.
- Have experience with BCG treatment or could not receive it due to availability issues.
- For Cohort 1: Cannot or choose not to have bladder removal surgery.
- For Cohorts 2 and 4: Willing and eligible for bladder removal surgery.
Part 4:
- Have a confirmed diagnosis of intermediate-risk non-muscle invasive bladder cancer.
- Have not had major tumor removal surgery; a small biopsy is allowed if enough tumor remains.
- Must provide tissue and urine samples for genetic testing.
- Can have another cancer that does not interfere with the study treatment.
Exclusion Criteria
Parts 1-3:
- Have cancer outside the bladder, such as in the urethra or kidneys.
- Have been treated with an FGFR inhibitor before.
- Had pelvic radiation therapy within the last 6 months.
- Have bladder or urethral issues that could make the treatment unsafe.
- Have a permanent urinary catheter (temporary use is okay).
Part 4:
- Have a diagnosis of more advanced bladder cancer or cancer that has spread.
- Have allergies or intolerances to the study drug or its ingredients.
- Have a current diagnosis of primary intermediate-risk bladder cancer.
- Have received experimental treatment for bladder cancer recently or are in another study.
- Have a current bladder perforation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Southern California | 90033 | Los Angeles | California |
| H Lee Moffitt Cancer Center | 33612 | Tampa | Florida |
| Northwestern University | 60611 | Chicago | Illinois |
| Levine Cancer Institute, Carolinas HealthCare System | 28204 | Charlotte | North Carolina |
| Carolina Urologic Research Center | 29572 | Myrtle Beach | South Carolina |
| Urology Associates | 37209 | Nashville | Tennessee |
| Urology San Antonio Research | 78229 | San Antonio | Texas |
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