drugset / Trial / NCT04006691

Efficacy and Safety of UGN-101 in Recurrent Patients

NCT04006691

Phase 3 Withdrawn UroGen Pharma Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This trial is designed to evaluate the efficacy and safety of UGN-101 administered to the upper urinary tract (UUT) in patients who were treated in Trial TC-UT-03, found to be a complete response (CR) at the Primary Disease Evaluation (PDE) 1 Visit and are subsequently found to have a documented recurrence of low grade (LG) upper tract urothelial carcinoma (UTUC) at follow up (FU).

Timeline

Start
2019-10-01
Primary completion
2020-03-31
Completion
2020-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitomycin C Other / unclassified 4 mg/ml Other