drugset / Trial / NCT02307487
Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitomycin C | Other / unclassified | 120 mg | Other |
| Subject | Mitomycin C | Other / unclassified | 140 mg | Other |
| Subject | Mitomycin C | Other / unclassified | 160 mg | Other |