drugset / Trial / NCT01878188
Pilot Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BC-819/PEI | Unknown | — | Other |
| Subject | BCG vaccine | Vaccine | — | Other |