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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

Interventions

EN3348
Mitomycin C

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

Useful links and downloads for this trial

Clinicaltrials.gov

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