A Phase II Study of Oral Erdafitinib in People with Recurrent Non-Invasive Bladder Cancer

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Full Title

A Phase 2 “Window of Opportunity” Trial of Targeted Therapy with Erdafitinib in Patients with Recurrent FGFR3-Altered Non-Muscle Invasive Bladder Cancer

Purpose

The purpose of this study is to assess the safety and effectiveness of erdafitinib to treat people with non-muscle invasive bladder cancer (NMIBC) that has come back after standard treatment, such as Bacillus Calmette-Guerin (BCG) or chemotherapy given into the bladder. Participants in this study will have bladder cancer with a mutation in the FGFR3 gene. FGFR3 mutations are the most common genetic alteration in NMIBC and are present in most recurrent NMIBC tumors. Erdafitinib is an oral pill that blocks the protein made by this altered gene, which may stop cancer cells from growing.

Researchers are doing this study to see if erdafitinib is an effective treatment when used after a patient’s NMIBC has come back, but before planned bladder tumor surgery. Erdafitinib is already used as an approved treatment for metastatic bladder cancer; its use in this study is investigational.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have NMIBC that has come back after prior treatment (instillations of BCG or chemotherapy into the bladder).
  • Genetic testing of each participant’s prior or recurrent NMIBC tumor will be performed to confirm it has an FGFR3 mutation.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Eugene Pietzak at 646-422-4781.

Protocol

21-166

Phase

II

Investigator