drugset / Trial / NCT02307487

Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients

NCT02307487

Phase 2 Completed 14 enrolled UroGen Pharma Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

A prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is designed to carefully assess the safety of successive cohorts of patients (3 patients/cohort), each cohort treated with a fixed dose of TC-3 and MMC Intravesical instillations.

Timeline

Start
2014-12
Primary completion
2016-04
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitomycin C Other / unclassified 120 mg Other
Subject Mitomycin C Other / unclassified 140 mg Other
Subject Mitomycin C Other / unclassified 160 mg Other