- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01284205
First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
August 28, 2014 updated by: Bioniche Life Sciences Inc.
Randomized, Double-blind, Multi-center Study Comparing MCC to BCG as First Line Immunotherapy in Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Recurrence or Progression
The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Laguna Hills, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Colorado
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Englewood, Colorado, United States
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Florida
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Daytona Beach, Florida, United States
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Kansas
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Overland Park, Kansas, United States
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Louisiana
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Shreveport, Louisiana, United States
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New York
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Garden City, New York, United States
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New York, New York, United States
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
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South Carolina
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Myrtle Beach, South Carolina, United States
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Texas
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McAllen, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Virginia
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Norfolk, Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- histologically confirmed urothelial carcinoma of the bladder (high grade Ta or T1 papillary lesions, CIS)
- 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 muscle invasive bladder tumors (>T2)
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: MCC
Intravesical Administration of Mycobacterial Cell-Wall DNA Complex
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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.
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Active Comparator: BCG
Intravesical Administration of Bacillus Calmette-Guerin
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of disease-free survival (time to recurrence, progression or death) in all patients
Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
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Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
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Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs
Time Frame: Baseline through 24 months
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Baseline through 24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease-free survival rate at 2 years
Time Frame: Month 24
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Month 24
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Frequency, severity, and nature of drug-related AEs
Time Frame: Baseline through 24 Months
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Baseline through 24 Months
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Duration of progression-free survival (time to progression or death) in all patients
Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60
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Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60
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Frequency, severity, and nature of drug-related SAEs
Time Frame: Baseline through 24 months
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Baseline through 24 months
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Number of treatment delays and their reason
Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
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Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
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Frequency, severity and nature of all AEs
Time Frame: Baseline through 24 months
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Baseline through 24 months
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Number of treatment discontinuations and their reason
Time Frame: Baseline through 24 months
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Baseline through 24 months
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Duration of Survival (time to death from any cause) in all patients
Time Frame: Baseline through month 60
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Baseline through month 60
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Anticipated)
February 1, 2014
Study Completion (Anticipated)
February 1, 2017
Study Registration Dates
First Submitted
January 25, 2011
First Submitted That Met QC Criteria
January 25, 2011
First Posted (Estimate)
January 26, 2011
Study Record Updates
Last Update Posted (Estimate)
August 29, 2014
Last Update Submitted That Met QC Criteria
August 28, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EN3348-302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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