A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Time to Recurrence
Time to recurrence (from randomization) for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo.
Recurrence of cancer in the bladder during 24 months of follow-up
No
Randil Clark, MD
Principal Investigator
North Idaho Urology
United States: Food and Drug Administration
SPI-1011
NCT01410565
July 2011
December 2015
Name | Location |
---|---|
University of Minnesota | Minneapolis, Minnesota 55455 |
North Idaho Urology | Couer D'Alene, Idaho 83814 |
Connecticut Clinical Research Center | Waterbury, Connecticut 06708-2652 |
Urological Associates Of Lancaster | Lancaster, Pennsylvania 17604-3200 |
South Orange County Medical Research Center | Laguna Hills, California 92653 |
Northeast Indiana Research, LLC | Fort Wayne, Indiana 46825-1675 |
Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
Urology of Virginia, PC | Norfolk, Virginia 23507 |
Regional Urology, LLC | Shreveport, Louisiana 71106 |
Valley Urologic Associates | Goodyear, Arizona 85338 |
Anne Arundel Urology | Annapolis, Maryland 21401 |
Urology Enterprises | Marietta, Georgia 30060 |
University Urology Associates | New York, New York 10016 |
Urology Associates of South Texas | McAllen, Texas 78503 |
The Urology Center of Colorado | Denver, Colorado 80211 |
Idaho Urologic Institute, P.A. | Meridian, Idaho 83642 |
Five Valleys Urology | Missoula, Montana 59802 |
Delaware Valley Urology, LLC - Voorhees | Voorhees, New Jersey 08043 |
Delaware Valley Urology, LLC-Westampton | Westampton, New Jersey 08060 |
Urology Associates of Rochester, LLC | Rochester, New York 14618 |
TriState Urologic Services PSC, Inc. | Cincinnati, Ohio 45212 |
Integrity Medical Research, LLC | Mountlake Terrace, Washington 98043 |
Spectrum Health Medical Group | Grand Rapids, Michigan 69546 |
Urology of Virginia, PLLC | Virginia Beach, Virginia 23462 |
Precision Trials, LLC | Phoenix, Arizona 85032 |
First Urology, PSC | Jeffersonville, Indiana 47130 |
Urologic Consultants of Southeastern Pennsylvania, LLP | Bala Cynwyd, Pennsylvania 19004 |
Urology Health Specialists | Bryn Mawr, Pennsylvania 19010 |