Randomized Phase 2 Study of Erdafitinib vs Investigator Choice of Chemo in Subjects Who Received BCG and Recurred With HR NMIBC (42756493BLC2003)

Brief description of study

The purpose of the study is to determine the safety and efficacy of erdafitinib in subjects with Non-Muscle-Invasive Bladder Cancer (NMIBC) and fibroblast growth factor receptor (FGFR) mutations or fusions. We want to know how your body tolerates erdafitinib, how effective erdafitinib may be, and how erdafitinib is taken up by your body when administered orally. Erdafitinib(JNJ-42756493) is an oral pan-fibroblast growth factor receptor (FGFR) 1-4 inhibitor with demonstrated clinical activity in subjects with solid tumors, including urothelial carcinoma, with alterations in the FGFR pathway. The study drug erdafitinib is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s19-01610
ClinicalTrials.gov Identifier: NCT04172675
Principal Investigator: Gary D. Steinberg.


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