drugset / Trial / NCT01878188

Pilot Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma

NCT01878188

Phase 1 Completed 38 enrolled Anchiano Therapeutics Israel Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

* Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG (number of participants with AEs, discontinuations due to AEs) * Recurrence after treatment with BC-819/PEI and BCG * Approximately 38 patients with superficial transitional cell carcinoma TCC) of the bladder * After initial evaluation and qualification, patients will be randomized to one of three treatment groups, either alternating, sequential or twice weekly

Timeline

Start
2013-02
Primary completion
2015-10
Completion
2017-10

Drugs

EvaluationDrugModalityDoseRoute
Subject BC-819/PEI Unknown Other
Subject BCG vaccine Vaccine Other