Spots Global Cancer Trial Database for Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
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Trial Identification
Brief Title: Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
Official Title: 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
Study ID: NCT01200992
Study Description
Brief Summary: This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide. Subjects with either recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will be eligible for participation in this study. Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1, and/or CIS) at least 6 months from the start of a full induction course of BCG with or without maintenance/re-treatment at 3 months. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months following a full induction course of BCG with or without maintenance/re-treatment at 3 months. Subjects with recurrent disease must have recurred within 18 months following the last dose of BCG. Approximately 450 subjects will be randomized. 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. The secondary objective is to evaluate the safety of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent or refractory NMIBC. This study will consist of 4 phases: Screening, Induction, Maintenance and Follow-Up and will be conducted over 3 years.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Clinical Research Center, LLC, Anchorage, Alaska, United States
BCG Oncology, PC, Phoenix, Arizona, United States
Arizona Urologic Specialists, Tucson, Arizona, United States
Urology Specialists of Southern California - Burbank, Burbank, California, United States
Urology Specialist of Southern California - Encino, Encino, California, United States
American Institute of Research, Los Angeles, California, United States
San Diego Clinical Trials, San Diego, California, United States
West Coast Clinical Research, Tarzana, California, United States
Urology Specialists of Southern California - Torrance, Torrance, California, United States
The Urology Center of Colorado, Denver, Colorado, United States
Genitourinary Surgical Consultants, PC, Denver, Colorado, United States
Urology Associates, Englewood, Colorado, United States
University of Connecticut Health Center, Farmington, Connecticut, United States
Grove Hill Medical Center, New Britain, Connecticut, United States
Florida Urological Associates, PA, Coral Springs, Florida, United States
Urological Research Network, Hialeah, Florida, United States
Urology Health Team, PLLC, Ocala, Florida, United States
Advanced Research Institute, Inc., Trinity, Florida, United States
Northwestern Medicine, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Deaconess Clinic, Inc., Evansville, Indiana, United States
Northeast Indiana Research, LLC, Fort Wayne, Indiana, United States
Kansas City Urology Care, P.A., Overland Park, Kansas, United States
University of Maryland, Baltimore, Maryland, United States
Chesapeake Urology Research Associates, Baltimore, Maryland, United States
Corbin Clinical Resources, Cumberland, Maryland, United States
Chesapeake Urology Research Associates, Glen Burnie, Maryland, United States
Myron I. Murdock, MD, LLC, Greenbelt, Maryland, United States
Chesapeake Urology Research Associates, Towson, Maryland, United States
Bay State Urologists, Watertown, Massachusetts, United States
Michigan Institute of Urology, Troy, Michigan, United States
Delaware Valley Urology, LLC Burlington, Mount Laurel, New Jersey, United States
Delaware Valley Urology, Voorhees, New Jersey, United States
The Capital Region Medical Research Foundation, Inc., Albany, New York, United States
Accumed Research Associates, Garden City, New York, United States
Columbia University Medical Center, New York, New York, United States
Premier Medical Group of the Hudson Valley, Poughkeepsie, New York, United States
Montefiore Medical Center, The Bronx, New York, United States
TriState Urologic Services PSC, Inc., Cincinnati, Ohio, United States
Columbus Urology, Columbus, Ohio, United States
Signal Point Clinical Research Center, LLC, Middletown, Ohio, United States
Unison Clinical Research, Toledo, Ohio, United States
Parkhurst Research Organization, LLC, Bethany, Oklahoma, United States
Urologic Consultants of SE PA, Bala-Cynwyd, Pennsylvania, United States
Urology Health Specialists, LLC, Bryn Mawr, Pennsylvania, United States
Ilumina Clinical Associates, Indiana, Pennsylvania, United States
Triangle Urological Group, Pittsburgh, Pennsylvania, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Mount Nittany Physician Group, State College, Pennsylvania, United States
Pharma Resource, East Providence, Rhode Island, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Urology Associates of North Texas, Arlington, Texas, United States
Urology Clinics of North Texas, PA, Dallas, Texas, United States
Urology Associates of South Texas, McAllen, Texas, United States
Virginia Urology, Richmond, Virginia, United States
Southern Interior Medical Research, Inc., Kelowna, British Columbia, Canada
Pacific Urologic Research, Victoria, British Columbia, Canada
London Health Sciences Centre, London, Ontario, Canada
Mor Urology Inc., Newmarket, Ontario, Canada
Office of Dr. Bernard Goldfarb, North Bay, Ontario, Canada
The Fe/Male Health Centres, Oakville, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Princess Margaret Hospital - University Health Network, Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Quebec- L'Hotel-Dieu de Quebec, Quebec City, Quebec, Canada
GUT (Society of Urologic Innovative Therapies), GbR, Kirchheim unter Teck, , Germany
Universitair Medisch Centrum St Radboud, Department of Urology, Nijmegen, , Netherlands
Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
Oddział Urologii, Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie [Department of Urology, Independent Public Teaching Hospital #4 in Lublin], Lublin, , Poland
Maria Sklodowska-Curie Institute of Oncology, Warszawa, , Poland
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Wroclaw, , Poland
Nottingham Urology Centre, NHS Trust, Nottingham, , United Kingdom
Contact Details
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