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

PHASE3TerminatedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

April 30, 2013

Study Completion Date

December 31, 2013

Conditions
Bladder NeoplasmNeoplasm Recurrence, LocalTransitional Cell, CarcinomaCarcinoma in SituMycobacterium
Interventions
BIOLOGICAL

EN3348

Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12

BIOLOGICAL

Mitomycin C

Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12

Trial Locations (72)

6525

Universitair Medisch Centrum St Radboud, Department of Urology, Nijmegen

10032

Columbia University Medical Center, New York

10467

Montefiore Medical Center, The Bronx

11530

Accumed Research Associates, Garden City

12208

The Capital Region Medical Research Foundation, Inc., Albany

12601

Premier Medical Group of the Hudson Valley, Poughkeepsie

15212

Triangle Urological Group, Pittsburgh

15232

University of Pittsburgh, Pittsburgh

15701

Ilumina Clinical Associates, Indiana

16801

Mount Nittany Physician Group, State College

19004

Urologic Consultants of SE PA, Bala-Cynwyd

19010

Urology Health Specialists, LLC, Bryn Mawr

20770

Myron I. Murdock, MD, LLC, Greenbelt

21061

Chesapeake Urology Research Associates, Glen Burnie

21201

University of Maryland, Baltimore

21204

Chesapeake Urology Research Associates, Towson

21237

Chesapeake Urology Research Associates, Baltimore

21502

Corbin Clinical Resources, Cumberland

23235

Virginia Urology, Richmond

29572

Carolina Urologic Research Center, Myrtle Beach

33016

Urological Research Network, Hialeah

33071

Florida Urological Associates, PA, Coral Springs

34474

Urology Health Team, PLLC, Ocala

34655

Advanced Research Institute, Inc., Trinity

37232

Vanderbilt University Medical Center, Nashville

43220

Columbus Urology, Columbus

43615

Unison Clinical Research, Toledo

45042

Signal Point Clinical Research Center, LLC, Middletown

45212

TriState Urologic Services PSC, Inc., Cincinnati

46825

Northeast Indiana Research, LLC, Fort Wayne

47713

Deaconess Clinic, Inc., Evansville

48084

Michigan Institute of Urology, Troy

60611

Northwestern Medicine, Chicago

60637

University of Chicago, Chicago

66211

Kansas City Urology Care, P.A., Overland Park

73008

Parkhurst Research Organization, LLC, Bethany

73230

GUT (Society of Urologic Innovative Therapies), GbR, Kirchheim unter Teck

75231

Urology Clinics of North Texas, PA, Dallas

76017

Urology Associates of North Texas, Arlington

78503

Urology Associates of South Texas, McAllen

80113

Urology Associates, Englewood

80211

The Urology Center of Colorado, Denver

80220

Genitourinary Surgical Consultants, PC, Denver

85032

BCG Oncology, PC, Phoenix

85712

Arizona Urologic Specialists, Tucson

90017

American Institute of Research, Los Angeles

90505

Urology Specialists of Southern California - Torrance, Torrance

91356

West Coast Clinical Research, Tarzana

91436

Urology Specialist of Southern California - Encino, Encino

91505

Urology Specialists of Southern California - Burbank, Burbank

92120

San Diego Clinical Trials, San Diego

99508

Alaska Clinical Research Center, LLC, Anchorage

06030

University of Connecticut Health Center, Farmington

06052

Grove Hill Medical Center, New Britain

02472

Bay State Urologists, Watertown

08054

Delaware Valley Urology, LLC Burlington, Mount Laurel

08043

Delaware Valley Urology, Voorhees Township

02915

Pharma Resource, East Providence

V1Y 2H4

Southern Interior Medical Research, Inc., Kelowna

V8V 3N1

Pacific Urologic Research, Victoria

N6A 5W9

London Health Sciences Centre, London

L3X 1W1

Mor Urology Inc., Newmarket

P1B 7K8

Office of Dr. Bernard Goldfarb, North Bay

L6H 3P1

The Fe/Male Health Centres, Oakville

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2M9

Princess Margaret Hospital - University Health Network, Toronto

G1R 3S1

Centre Hospitalier Universitaire de Quebec- L'Hotel-Dieu de Quebec, Québec

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

20-954

Oddział Urologii, Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie [Department of Urology, Independent Public Teaching Hospital #4 in Lublin], Lublin

20-781

Maria Sklodowska-Curie Institute of Oncology, Warsaw

51-124

Wojewódzki Szpital Specjalistyczny we Wrocławiu, Wroclaw

NG5 1PB

Nottingham Urology Centre, NHS Trust, Nottingham

Sponsors
All Listed Sponsors
lead

Bioniche Life Sciences Inc.

INDUSTRY

NCT01200992 - 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 | Biotech Hunter | Biotech Hunter