Bladder Cancer Clinical Trial
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Summary
The purpose of the study in Part 1 (dose escalation) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and in Part 2 (dose expansion) is to determine the safety of Erdafitinib Intravesical Delivery System administered at the RP2D(s).
Full Description
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.
Eligibility Criteria
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
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There are 21 Locations for this study
Los Angeles California, 90033, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60611, United States
Charlotte North Carolina, 28204, United States
Myrtle Beach South Carolina, 29572, United States
Nashville Tennessee, 37209, United States
San Antonio Texas, 78229, United States
Frankfurt am Main , 60590, Germany
Herne , 44625, Germany
Münster , 48149, Germany
Ulm , 89081, Germany
Goyang-Si , 10408, Korea, Republic of
Gwangju , 61469, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06591, Korea, Republic of
Nijmegen , 6525 , Netherlands
Utrecht , 3584 , Netherlands
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28041, Spain
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