A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 17, 2022

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Bladder CancerRecurrent Bladder CancerFGFR3 Gene Mutation
Interventions
DRUG

Erdafitinib

Participants will receive erdafitinib at a dose of 6 mg orally once daily for the first 14 days (±3 days). Serum phosphate levels will be assessed on day 14 (±3 days) and the dose of erdafitinib may be lowered based on the serum phosphate level. Treatment with erdafitinib at a dose of 6 mg orally once daily, or at a lower dose level for another 14 days (±3 days) until the day of their standard-of-care TURBT/biopsy. Standard-of-care TURBT/biopsy will be performed after approximately 28 days (±5 days) from the start of treatment with erdafitinib, and biologic and pathologic tumor response will be assessed. All participants will then be followed up for recurrence or progression in accordance with the standard of care.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT04917809 - A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer | Biotech Hunter | Biotech Hunter