Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT01284205
Status:
WITHDRAWN
Last Update Posted:
2014-08-29
First Post:
2011-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001500', 'term': 'BCG Vaccine'}], 'ancestors': [{'id': 'D032581', 'term': 'Tuberculosis Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This indication is not being pursued at this point in time.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-28', 'studyFirstSubmitDate': '2011-01-25', 'studyFirstSubmitQcDate': '2011-01-25', 'lastUpdatePostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of disease-free survival (time to recurrence, progression or death) in all patients', 'timeFrame': 'Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24'}, {'measure': 'Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs', 'timeFrame': 'Baseline through 24 months'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival rate at 2 years', 'timeFrame': 'Month 24'}, {'measure': 'Frequency, severity, and nature of drug-related AEs', 'timeFrame': 'Baseline through 24 Months'}, {'measure': 'Duration of progression-free survival (time to progression or death) in all patients', 'timeFrame': 'Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60'}, {'measure': 'Frequency, severity, and nature of drug-related SAEs', 'timeFrame': 'Baseline through 24 months'}, {'measure': 'Number of treatment delays and their reason', 'timeFrame': 'Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24'}, {'measure': 'Frequency, severity and nature of all AEs', 'timeFrame': 'Baseline through 24 months'}, {'measure': 'Number of treatment discontinuations and their reason', 'timeFrame': 'Baseline through 24 months'}, {'measure': 'Duration of Survival (time to death from any cause) in all patients', 'timeFrame': 'Baseline through month 60'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['non-muscle invasive bladder cancer', 'superficial bladder cancer'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed urothelial carcinoma of the bladder (high grade Ta or T1 papillary lesions, CIS)\n* histologically confirmed diagnosis within 42 days of study treatment\n* life expectancy of greater than 5 years\n* ECOG performance status of 2 or less\n* absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from start of study treatment\n\nExclusion Criteria:\n\n* current or previous history of muscle invasive bladder tumors (\\>T2)\n* current or previous history of lymph node and/or distant metastases from bladder cancer\n* current evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the bladder\n* current systemic cancer therapy\n* previous immunotherapy for bladder cancer\n* previous intravesical chemotherapy treatment\n* contraindication to use BCG of known tolerance to BCG\n* 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)\n* patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)'}, 'identificationModule': {'nctId': 'NCT01284205', 'briefTitle': 'First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioniche Life Sciences Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EN3348-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCC', 'description': 'Intravesical Administration of Mycobacterial Cell-Wall DNA Complex', 'interventionNames': ['Biological: Mycobacterial Cell-Wall DNA Complex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BCG', 'description': 'Intravesical Administration of Bacillus Calmette-Guerin', 'interventionNames': ['Biological: Bacillus Calmette-Guerin']}], 'interventions': [{'name': 'Mycobacterial Cell-Wall DNA Complex', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['MCC']}, {'name': 'Bacillus Calmette-Guerin', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['BCG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioniche Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director of CRND', 'oldOrganization': 'Endo Pharmaceuticals Inc.'}}}}