IRB #

STUDY00022150

Title

A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

Principal Investigator

Sudhir Isharwal

Study Purpose

The purpose of this study is to see if erdafitinib is safe and useful for treating patients with high-risk non-muscle invasive bladder cancer (NMIBC) that recurred (came back) after BCG therapy and has a gene mutation or fusion called FGFR.

Medical Condition(s)

High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Eligibility Criteria

This study is open to patients with high-risk non-muscle invasive bladder cancer (NMIBC) that recurred (came back) after BCG therapy and has a gene mutation or fusion called FGFR.

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

If you join the study, you could be in it for up to a maximum of 4 years after your first dose of study drug. You may be contacted by phone, email or you may visit the study center at least once every 12 weeks for up to 2 years.

Minors Included

No

Contact

Knight Cancer Clinical Trials

Phone: 503-494-1080

Email: trials@ohsu.edu

Sponsor

Janssen Research & Development, LLC

Recruitment End

11/01/2022

Compensation Provided

No


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