The purpose of this study is to evaluate recurrence-free survival (RFS) in participants
treated with erdafitinib vs Investigator's Choice, for participants with high-risk
non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor
(FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG)
therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04172675.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Name Not Available
This study enrolls participants with high risk NMIBC and FGFR mutations or fusions.
Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) 1-4 inhibitor with
demonstrated clinical activity in participants with solid tumors, including urothelial
carcinoma, with alterations in the FGFR pathway. In Cohort 1, participants will be
randomized to erdafitinib or to Investigators Choice (intravesical gemcitabine or
intravesical mitomycin C [MMC] or hyperthermic MMC). The study consists of screening
period, treatment phase, follow-up phase, and long-term extension phase.
Lead OrganizationJanssen Pharmaceuticals
