Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT00160069
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530494', 'term': 'sagopilone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria.", 'timeFrame': 'Tumor evaluation (MRI or scan) every 2 cycles until disease progression.'}], 'secondaryOutcomes': [{'measure': 'Secondary objectives : investigate the safety and tolerability of ZK 219477', 'timeFrame': 'Continuously'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stage IIIB or stage IV non-small-cell lung cancer.'], 'conditions': ['Carcinoma, Non Small Cell Lung']}, 'referencesModule': {'references': [{'pmid': '23522488', 'type': 'RESULT', 'citation': 'Heigener DF, von Pawel J, Eschbach C, Brune A, Schmittel A, Schmelter T, Reck M, Fischer JR. Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy and safety of three regimens with two doses of sagopilone as second-line therapy in patients with stage IIIB or IV non-small-cell lung cancer. Lung Cancer. 2013 Jun;80(3):319-25. doi: 10.1016/j.lungcan.2013.02.007. Epub 2013 Mar 20.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu', 'label': 'Click here and search for Bayer product information provided by the EMA'}]}, 'descriptionModule': {'briefSummary': 'Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer.', 'detailedDescription': 'The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-small-cell lung cancer\n* Only one previous chemotherapy with a platinum-containing drug\n* Use of highly effective birth control methods in females of child-bearing potential\n\nExclusion Criteria:\n\n* No more than 1 previous chemotherapy for advanced disease\n* Previous participation in another trial within the last 4 weeks\n* Breast feeding\n* Active infections'}, 'identificationModule': {'nctId': 'NCT00160069', 'briefTitle': 'Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as Second Line Therapy in Patients With Stage IIIB or Stage IV Non Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': '91374'}, 'secondaryIdInfos': [{'id': '2005-000586-19', 'type': 'EUDRACT_NUMBER'}, {'id': '307971', 'type': 'OTHER', 'domain': 'Company Internal ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Sagopilone (BAY86-5302, ZK 219477)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: Sagopilone (BAY86-5302, ZK 219477)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'interventionNames': ['Drug: Sagopilone (BAY86-5302, ZK 219477)']}], 'interventions': [{'name': 'Sagopilone (BAY86-5302, ZK 219477)', 'type': 'DRUG', 'description': '16 mg/m2, 3-hour infusion, every 3 weeks', 'armGroupLabels': ['Arm 1']}, {'name': 'Sagopilone (BAY86-5302, ZK 219477)', 'type': 'DRUG', 'description': '22 mg/m2, 30-min infusion, every 3 weeks', 'armGroupLabels': ['Arm 2']}, {'name': 'Sagopilone (BAY86-5302, ZK 219477)', 'type': 'DRUG', 'description': '22 mg/m2, 3-hour infusion, every 3 weeks', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74245', 'city': 'Löwenstein', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'geoPoint': {'lat': 49.09558, 'lon': 9.38}}, {'zip': '86156', 'city': 'Augsburg', 'state': 'Bavaria', 'country': 'Germany', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '82131', 'city': 'Gauting', 'state': 'Bavaria', 'country': 'Germany', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'zip': '90419', 'city': 'Nuremberg', 'state': 'Bavaria', 'country': 'Germany', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '21075', 'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '65929', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '17475', 'city': 'Greifswald', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '17475', 'city': 'Stralsund', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'geoPoint': {'lat': 54.30911, 'lon': 13.0818}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '06120', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '39130', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '22927', 'city': 'Großhansdorf', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'zip': '12200', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14165', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '29325', 'city': 'Bremen', 'country': 'Germany', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '96250', 'city': 'Ebensfeld', 'country': 'Germany', 'geoPoint': {'lat': 50.0664, 'lon': 10.95835}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}