Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-22 @ 9:28 PM
Study NCT ID:
NCT00660504
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2008-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
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'otherNumAtRisk': 149, 'otherNumAffected': 149, 'seriousNumAtRisk': 149, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Etoposide, Anticancer, Injection', 'otherNumAtRisk': 150, 'otherNumAffected': 148, 'seriousNumAtRisk': 150, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'vomit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 63}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 50}], 'organSystem': 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149, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hiccup', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'alanine aminotransferase 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'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lower hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 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'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amrubicin Combined With Cisplatin Group', 'description': 'Amrubicin Hydrochloride-Cisplatin combined chemotherapy\n\nAmrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin'}, {'id': 'OG001', 'title': 'Etoposide Combined With Cisplatin Group', 'description': 'Etoposide-Cisplatin combined chemotherapy\n\nEtoposide-Cisplatin combined chemotherapy : combined chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '69.80', 'groupId': 'OG000'}, {'value': '57.33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'participants were followed for the duration of the study, an average of 12 weeks', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of 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'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Amrubicin, Anticancer, Injection'}, {'id': 'BG001', 'title': 'Etoposide, Anticancer, Injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '10.03', 'groupId': 'BG000'}, {'value': '57.45', 'spread': '9.78', 'groupId': 'BG001'}, {'value': '56.78', 'spread': '9.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-09', 'studyFirstSubmitDate': '2008-04-10', 'resultsFirstSubmitDate': '2013-11-21', 'studyFirstSubmitQcDate': '2008-04-10', 'lastUpdatePostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-03', 'studyFirstPostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall Survival at 6 and 12 Months', 'timeFrame': '6 and 12 months.'}], 'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '1.5 years after last subject enrolled'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': '1.5 years after last subject enrolled'}, {'measure': 'Objective Response Rate', 'timeFrame': 'participants were followed for the duration of the study, an average of 12 weeks', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Extensive Disease-Small Cell Lung Cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '27061082', 'type': 'DERIVED', 'citation': 'Sun Y, Cheng Y, Hao X, Wang J, Hu C, Han B, Liu X, Zhang L, Wan H, Xia Z, Liu Y, Li W, Hou M, Zhang H, Xiu Q, Zhu Y, Feng J, Qin S, Luo X. Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer. BMC Cancer. 2016 Apr 9;16:265. doi: 10.1186/s12885-016-2301-6.'}]}, 'descriptionModule': {'briefSummary': 'This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically/cytologically proven small cell lung cancer\n* Extensive disease\n* No prior chemotherapy regimen\n* Age 18 years or older\n* ECOG performance status of 0-1\n\nExclusion Criteria:\n\n* Brain metastasis requiring treatment\n* Treatment (Surgical or radiotherapy)of primary tumor\n* Interstitial pneumonia or pulmonary fibrosis\n* Abnormal cardiac function or myocardial infraction within 6 months before study enrollment'}, 'identificationModule': {'nctId': 'NCT00660504', 'briefTitle': 'Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma (Suzhou) Co., Ltd.'}, 'officialTitle': 'Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC', 'orgStudyIdInfo': {'id': 'D0750018'}, 'secondaryIdInfos': [{'id': 'D0750018'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Amrubicin Hydrochloride-Cisplatin combined chemotherapy', 'interventionNames': ['Drug: Amrubicin Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Etoposide-Cisplatin combined chemotherapy', 'interventionNames': ['Drug: Etoposide-Cisplatin combined chemotherapy']}], 'interventions': [{'name': 'Amrubicin Hydrochloride', 'type': 'DRUG', 'description': 'Amrubicin Hydrochloride combined with cisplatin', 'armGroupLabels': ['1']}, {'name': 'Etoposide-Cisplatin combined chemotherapy', 'type': 'DRUG', 'description': 'combined chemotherapy', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Dalian/Shenyang', 'state': 'Liaoning', 'country': 'China'}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Xian', 'state': 'Shanxi', 'country': 'China'}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'country': 'China', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Yan Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Hospital Chinese Academy of Medical Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumitomo Pharma (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}