A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel on Ablation of Upper Urinary Tract Urothelial Carcinomal Evaluating the Efficacy and Safety
Sponsor: |
UroGen Pharma |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ9319 |
U.S. Govt. ID: |
NCT02449239 |
Contact: |
Ojas Shah, MD: 212-305-0114 / os2302@cumc.columbia.edu |
The purpose of this study is to evaluate the effect and safety of MitoGel on patients with Upper TractUrothelial Carcinoma (UTUC). This research study is being done because this is a potentially beneficial new treatment for Low Grade UTUC. Mitomycin C (MMC) is FDA approved for other clinical indications and commercially available for the treatment of bladder cancer. UroGens MitoGel (a combination of Mitomycin C (MMC) and TC-3 gel) has not been approved by the FDA and is not commercially available. The gel is designed to safely maintain the MMC within the body to treat the bladder cancer. About 74 subjects will take part in this study worldwide.
This study is closed
Investigator
Ojas Shah, MD
Do you have non-invasive UTUC? |
Yes |
No |
Do you have bladder cancer? |
Yes |
No |
Have you had bladder cancer during the past 5 years? |
Yes |
No |