Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-29 @ 4:28 PM
Study NCT ID:
NCT01475266
Status:
TERMINATED
Last Update Posted:
2017-03-29
First Post:
2011-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (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': 'C060817', 'term': 'apaziquone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'whyStopped': "Sponsor's decision", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer', 'timeFrame': '2 years'}, {'measure': 'The progression rate', 'timeFrame': '2 years'}, {'measure': 'The number of recurrences per patient', 'timeFrame': '2 years'}, {'measure': 'The progression-free survival period', 'timeFrame': '2 years'}, {'measure': 'The recurrence-free survival period', 'timeFrame': '2 years'}, {'measure': 'The overall survival period', 'timeFrame': '2 years'}, {'measure': 'The safety of EO9', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bladder Cancer', 'NMIBC', 'TURBT', 'Apaziquone', 'EOquin', 'Immediate instillation'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have provided written informed consent\n2. Patients who have urothelial cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2 and satisfy both of the following criteria:\n\n * The maximum number of tumors is 5.\n * Each tumor diameter: ≤ 3.5 cm.\n3. Age: ≥20 years old at enrollment.\n4. The functions of the major organs are adequate, and the following test value criteria are satisfied:\n\n * Neutrophil count ≥1,500/μL\n * Platelet count ≥10×10\\^4/μL\n * Hemoglobin ≥10 g/dL\n\nExclusion Criteria:\n\n1. Patients with a single, primary bladder cancer of \\<0.5 cm.\n2. Patients with CIS lesions in the bladder or a history thereof.\n3. Patients with a history of other than stage Ta, histological grade G1 or G2 disease.\n4. Patients experiencing recurrence within 4 months following TURBT for prior NMIBC (duration between the last TURBT and cystoscopic confirmation of the present recurrence is within 4 months).\n5. Patients without at least a three-month cystoscopically confirmed recurrence-free interval between the last TURBT and the time of study screening\n6. Patients having a bladder tumor with a histological diagnosis other than urothelial carcinoma of the bladder or a history thereof.\n7. Patients who had been administered EO9 in the past.\n8. Patients who had been administered any other investigational drug within the past 30 days.\n9. Patients having a medical condition that would make it unsafe for them to undergo TURBT under general or spinal anesthesia.'}, 'identificationModule': {'nctId': 'NCT01475266', 'briefTitle': 'Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nippon Kayaku Co., Ltd.'}, 'officialTitle': 'Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC', 'orgStudyIdInfo': {'id': 'A9EO9201'}, 'secondaryIdInfos': [{'id': 'EO9_C301'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EO9 (Apaziquone)', 'interventionNames': ['Drug: EO9 (Apaziquone)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EO9 (Apaziquone)', 'type': 'DRUG', 'otherNames': ['Eoquin(R)'], 'description': '4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT', 'armGroupLabels': ['EO9 (Apaziquone)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '40 mL, Intravesical instillation, Single dose within 6 hours after TURBT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yokosuka', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Nippon Kayaku Investigational site 103', 'geoPoint': {'lat': 35.28361, 'lon': 139.66722}}, {'city': 'Kashihara', 'state': 'Nara', 'country': 'Japan', 'facility': 'Nippon Kayaku Investigational site 107', 'geoPoint': {'lat': 33.95, 'lon': 135.78333}}, {'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Nippon Kayaku Investigational site 109', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'city': 'Sayama', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Nippon Kayaku Investigational site 105', 'geoPoint': {'lat': 34.51685, 'lon': 135.56298}}, {'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Nippon Kayaku Investigational site 104', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'city': 'Musashino', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Nippon Kayaku Investigational site 102', 'geoPoint': {'lat': 35.70611, 'lon': 139.55944}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Nippon kayaku Investigational site 101', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Nippon Kayaku Investigational site 110', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Nippon Kayaku Investigational site 111', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Nara', 'country': 'Japan', 'facility': 'Nippon Kayaku Investigational site 106', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Nippon Kayaku Investigational site 108', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Bundang', 'country': 'South Korea', 'facility': 'Handok Investigational site 203'}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Handok Investigational site 202', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Hwasun', 'country': 'South Korea', 'facility': 'Handok Investigational site 209', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Handok Investigational site 201', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Handok Investigational site 204', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Handok Investigational site 205', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Handok Investigational site 206', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Handok Investigational site 207', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Handok Investigational site 208', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Yoshihiro Nambu, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nippon Kayaku Co., Ltd.'}, {'name': 'Woo Ick Jang, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Handok Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nippon Kayaku Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Handok Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}