Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Last Updated   July 17, 2024 - 21:06
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 1Researchers test a new drug or treatment in a small group of people for the first time to gather information on its safety, dosing, and side effects. -
Sites
sites -
Status
Recruiting
SUMMARY
Bladder cancer is one of the most common malignancy worldwide, and non-muscle invasive (NMIBC) requires intensive regimens of frequent monitoring and local resection (transurethral resection of bladder [TURBT]). This study enrolls participants with non-muscle invasive or muscle invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when administered orally in patients with solid tumors, including bladder cancer, with FGFR genetic alterations. The Erdafitinib intravesical delivery system is designed to provide release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing systemic toxicities. The study consists of a screening phase, a treatment phase, and a follow-up phase. Total duration of the study is 5 years 3 months.
CONDITIONS
- Bladder Cancer
- Receptors, Fibroblast Growth Factor
ELIGIBILITY
Inclusion Criteria:
* Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder
* For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests
* Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible
* Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)
* Cohorts 2 and 4: Willing and eligible for RC
Exclusion Criteria:
* Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium
* Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor
* Received pelvic radiotherapy <=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis
* Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system
* Indwelling urinary catheter. Intermittent catheterization is acceptable
DETAILS
Bladder cancer is one of the most common malignancy worldwide, and non-muscle invasive (NMIBC) requires intensive regimens of frequent monitoring and local resection (transurethral resection of bladder \[TURBT\]). This study enrolls participants with non-muscle invasive or muscle invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when administered orally in patients with solid tumors, including bladder cancer, with FGFR genetic alterations. The Erdafitinib intravesical delivery system is designed to provide release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing systemic toxicities. The study consists of a screening phase, a treatment phase, and a follow-up phase. Total duration of the study is 5 years 3 months.
LOCATIONS
Country (5) | City or Province (21) | Status |
United States | Charlotte, NC Levine Cancer Institute, Carolinas HealthCare System |
RECRUITING
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United States | Chicago, IL Northwestern University |
RECRUITING
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United States | Los Angeles, CA University of Southern California |
RECRUITING
|
United States | Myrtle Beach, SC Carolina Urologic Research Center |
RECRUITING
|
United States | Nashville, TN Urology Associates |
RECRUITING
|
United States | San Antonio, TX Urology San Antonio Research |
RECRUITING
|
United States | Tampa, FL H Lee Moffitt Cancer Center |
RECRUITING
|
Spain | Barcelona, BA Fund. Puigvert |
COMPLETED
|
Spain | Barcelona, BA Hosp Clinic de Barcelona |
RECRUITING
|
Spain | Barcelona, BA Hosp Univ Vall D Hebron |
RECRUITING
|
Spain | Madrid, MD Hosp. Univ. 12 de Octubre |
RECRUITING
|
South Korea | Goyang-Si, 41 National Cancer Center |
RECRUITING
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South Korea | Gwangju, 46 Chonnam National University Hospital |
RECRUITING
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South Korea | Seoul Seoul National University Hospital |
RECRUITING
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South Korea | Seoul The Catholic University of Korea Seoul St Marys Hospital |
RECRUITING
|
Netherlands | Nijmegen, GE Radboud Umcn |
COMPLETED
|
Netherlands | Utrecht, UT UMC Utrecht |
COMPLETED
|
Germany | Frankfurt am Main, HE Universitatsklinikum Frankfurt |
RECRUITING
|
Germany | Herne Marien hospital Herne |
RECRUITING
|
Germany | Münster Universitatsklinikum Munster |
RECRUITING
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Germany | Ulm, BW Universitaetsklinikum Ulm |
RECRUITING
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