An Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium in Subjects with Non Muscle-Invasive Carcinoma in Situ (CIS) and/or High-Grade Papillary Disease of the Bladder Previously Treated with Bacillus Calmette-Gurin (BCG)
Sponsor: |
Viventia |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ5802 |
U.S. Govt. ID: |
NCT02449239 |
Contact: |
Joel DeCastro: 212-305-0114 / gjd16@cumc.columbia.edu |
This study is designed to obtain information on the safety and the effectiveness of an experimental drug called Vicinium when it is given to human subject(s)/participant(s) with bladder cancer that has not spread to the muscle of the bladder. Vicinium is part of an antibody connected to a protein that can kill cells. The protein is a modified pseudomonas exotoxin A. Vicinium is designed to attach to cells that have a different protein called EpCAM on the outside of the cell. After attaching to a cell, the modified pseudomonas exotoxin A can be released in the cell causing the cell to die. It is thought that almost all bladder cancer cells has EpCAM on the outside. About 70 medical centers in North America (United States and Canada) are expected to participate in this study. About 134 subject(s)/participant(s) will participate in the study. Male and non-pregnant/non-lactating females age 18 years or older that meet all study requirements will be able to participate in this study. The expected treatment length of this study is up to 24 months.
This study is closed
Investigator
Joel DeCastro, MD, MPH
Have you been diagnosed with bladder cancer? |
Yes |
No |