Study on Oral Erdafitinib for Recurrent Non-Invasive Bladder Cancer

Inclusion Criteria

• Have non-muscle invasive bladder cancer (NMIBC) that has returned after previous treatments like BCG or chemotherapy.
• Tumor testing must confirm an FGFR3 gene mutation.
• Be able to walk and perform daily activities for more than half of the day.
• Be 18 years or older.
• Willing to provide written consent to participate.
• Have documentation of an FGFR3 mutation or gene fusion from previous or current tumor samples.
• Have a history of certain types of papillary tumors after at least one course of bladder treatment.
• Meet specific health criteria, including adequate blood cell counts and organ function.
• Be able to swallow pills.
• Women of childbearing potential must use birth control or abstain from sex during the study and for 120 days after the last dose.
• Men must use condoms during sex and avoid fathering a child during the study and for 120 days after the last dose.

Exclusion Criteria

• Have impaired decision-making ability.
• Be pregnant or breastfeeding.
• Have or have had muscle-invasive or metastatic bladder cancer.
• Have cancer outside the bladder, like in the urethra or kidneys.
• Have only carcinoma in situ (stage Tis) or concurrent carcinoma in situ.
• Meet criteria for BCG-unresponsive NMIBC.
• Have had or are scheduled for radiation treatment for bladder cancer.
• Have had chemotherapy, targeted therapy, or investigational drugs recently.
• Have had immunotherapy recently or have ongoing side effects from it.
• Have recent heart issues or severe heart failure.
• Have bleeding disorders.
• Have had a stroke or mini-stroke recently.
• Have used FGFR inhibitors before.
• Have digestive issues affecting drug absorption.
• Have calcium or phosphate imbalances.
• Use medications affecting phosphorus or calcium levels.
• Use medications that strongly affect certain liver enzymes.
• Have eye disorders confirmed by an eye doctor.