First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
NCT ID: NCT01284205
Last Updated: 2014-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE3
INTERVENTIONAL
2010-01-31
2017-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MCC
Intravesical Administration of Mycobacterial Cell-Wall DNA Complex
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.
BCG
Intravesical Administration of Bacillus Calmette-Guerin
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* histologically confirmed diagnosis within 42 days of study treatment
* life expectancy of greater than 5 years
* ECOG performance status of 2 or less
* absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from start of study treatment
Exclusion Criteria
* current or previous history of lymph node and/or distant metastases from bladder cancer
* current evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the bladder
* current systemic cancer therapy
* previous immunotherapy for bladder cancer
* previous intravesical chemotherapy treatment
* contraindication to use BCG of known tolerance to BCG
* history of malignancy of any organ system within the past 5 years (with the exception of basal cell or squamous cell carcinoma, stage T1 prostate cancer, carcinoma in situ of the cervix, colon polyps)
* patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bioniche Life Sciences Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Endo Pharmaceuticals Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Laguna Hills, California, United States
Los Angeles, California, United States
San Diego, California, United States
Englewood, Colorado, United States
Daytona Beach, Florida, United States
Overland Park, Kansas, United States
Shreveport, Louisiana, United States
Garden City, New York, United States
New York, New York, United States
Pittsburgh, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
McAllen, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EN3348-302
Identifier Type: -
Identifier Source: org_study_id