A Phase 2, Randomized, Open Label, Parallel Arm Study to Evaluate the Safety and Efficacy of rAd-IFN/Syn3 Following Intravesical Administration in Subjects With High Grade, BCG Refractory or Relapsed Non-Muscle Invasive Bladder Cancer (NMIBC)
Criteria for Evaluation:
Efficacy: A Response is defined as no evidence of recurrence of a high grade tumor by
cystoscopy, cytology or if clinically indicated, biopsy.
Safety: The safety and tolerability of INSTILADRIN will be evaluated based on adverse event
reports, vital signs, ECGs, clinical laboratory values and results of physical examination.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the incidence of high grade-recurrence free survival following up to 4 instillations of INSTILADRIN
12 months
No
Colin Dinney, MD
Study Chair
M.D. Anderson Cancer Center
United States: Food and Drug Administration
rAd-IFN-CS-002
NCT01687244
September 2012
June 2014
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Mayo Clinic | Rochester, Minnesota 55905 |
Emory University | Atlanta, Georgia 30322 |
Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
Washington University | St. Louis, Missouri 63110 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
Johns Hopkins Hospital | Baltimore, Maryland 21287 |
The Urology Center of Colorado | Denver, Colorado 80211 |
The University Of Texas Health Science Center | San Antonio, Texas 78229 |