First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2010

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2017

Conditions
Bladder Cancer
Interventions
BIOLOGICAL

Mycobacterial Cell-Wall DNA Complex

8 mg/50 mL (sterile WFI) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.

BIOLOGICAL

Bacillus Calmette-Guerin

mg/50 mL (sterile saline) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.

Trial Locations (14)

Unknown

Laguna Hills

Los Angeles

San Diego

Englewood

Daytona Beach

Overland Park

Shreveport

Garden City

New York

Pittsburgh

Myrtle Beach

McAllen

Salt Lake City

Norfolk

Sponsors
All Listed Sponsors
lead

Bioniche Life Sciences Inc.

INDUSTRY

NCT01284205 - First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC | Biotech Hunter | Biotech Hunter