drugset / Trial / NCT01284205

First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC

NCT01284205

Phase 3 Withdrawn Bioniche Life Sciences Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.

Timeline

Start
2010-01
Primary completion
2014-02
Completion
2017-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bacillus Calmette-Guérin Vaccine Other
Subject Mycobacterial Cell-Wall DNA Complex Unknown 8 mg Other