A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of this study is to evaluate the efficacy of intravesical EN3348 as compared with mitomycin C in the treatment of subjects with recurrent or refractory NMIBC.
1 year
No
United States: Food and Drug Administration
EN3348-303
NCT01200992
November 2010
December 2013
Name | Location |
---|---|
University of Connecticut Health Center | Farmington, Connecticut 06360-7106 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Michigan Institute of Urology | Detroit, Michigan 48236 |
Urology Associates of North Texas | Arlington, Texas 76015 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
University of Maryland | Baltimore, Maryland 21201 |
University of Chicago | Chicago, Illinois 60637 |
Alaska Clinical Research Center, LLC | Anchorage, Alaska 99508 |
AccuMed Research Associates | Garden City, New York 11530 |
Northeast Indiana Research, LLC | Fort Wayne, Indiana 46825-1675 |
Advanced Research Institute, Inc. | New Port Richey, Florida 34652 |
Triangle Urological Group | Pittsburgh, Pennsylvania 15212 |
Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
Columbia University Medical Center | New York, New York 10032 |
Arizona Urologic Specialists | Tucson, Arizona 85712 |
West Coast Clinical Research | Tarzana, California 91356 |
Urology Associates | Denver, Colorado 80210 |
Urology Associates of South Texas | McAllen, Texas 78503 |
San Diego Clinical Trials | San Diego, California 92120 |
Chesapeake Urology Research Associates | Towson, Maryland 21204 |
Signal Point Clinical Research Center, LLC | Middletown, Ohio 45042 |
The Urology Center of Colorado | Denver, Colorado 80211 |
Kansas City Urology Care, P.A. | Overland Park, Kansas 66211 |
TriState Urologic Services PSC, Inc. | Cincinnati, Ohio 45212 |
Urologic Consultants of SE PA | Bala Cynwyd, Pennsylvania 19004 |
Urology Clinics of North Texas, PA | Dallas, Texas 75231 |
Pharma Resource | East Providence, Rhode Island 02915 |
Deaconess Clinic, Inc. | Evansville, Indiana 47713 |
BCG Oncology, PC | Phoenix, Arizona 85032 |
Grove Hill Medical Center | New Britain, Connecticut |
Virginia Urology | Richmond, Virginia 23235 |
American Institute of Research | Whittier, California 90603 |
Urology Specialists of Southern California - Burbank | Burbank, California 91505 |
Urology Specialist of Southern California - Encino | Encino, California 91436 |
Urology Specialists of Southern California - Torrance | Torrance, California 90505 |
Genitourinary Surgical Consultants, PC | Denver, Colorado 80220 |
Florida Urological Associates, PA | Coral Springs, Florida 33071 |
Urological Research Network | Hialeah, Florida 33016 |
Urology Health Team, PLLC | Ocala, Florida 34474 |
Northwestern Medicine | Chicago, Illinois 60611 |
Corbin Clinical Resources | Cumberland, Maryland 21502 |
Myron I. Murdock, MD, LLC | Greenbelt, Maryland 20770 |
Bay State Urologists | Watertown, Massachusetts 02472 |
Delaware Valley Urology, LLC Burlington | Mt. Laurel, New Jersey 08054 |
Delaware Valley Urology | Sewell, New Jersey 08080 |
The Capital Region Medical Research Foundation, Inc. | Albany, New York 12208 |
Premier Medical Group of the Hudson Valley | Poughkeepsie, New York 12601 |
Columbus Urology | Columbus, Ohio 43220 |
Unison Clinical Research | Toledo, Ohio 43615 |
Parkhurst Research Organization, LLC | Bethany, Oklahoma 73008 |
Urology Health Specialists, LLC | Bryn Mawr, Pennsylvania 19010 |
Ilumina Clinical Associates | Indiana, Pennsylvania 15701 |
Mount Nittany Physician Group | State College, Pennsylvania 16801 |