Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 2:55 PM
Study NCT ID:
NCT01027208
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2009-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C430592', 'term': 'ixabepilone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-27', 'studyFirstSubmitDate': '2009-12-04', 'studyFirstSubmitQcDate': '2009-12-04', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163107) and are benefiting from continuation on therapy with Ixabepilone as determined by the treating investigator', 'timeFrame': '21-day cycles until documented disease progression or unacceptable toxicity'}, {'measure': 'To evaluate the frequency and the severity of observed adverse reactions in treated patients, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0', 'timeFrame': '21-day cycles until documented disease progression or unacceptable toxicity'}], 'secondaryOutcomes': [{'measure': 'Secondary objectives will be assessed by combining data with the previous Phase II study CA163107', 'timeFrame': '21-day cycles until documented disease progression or unacceptable toxicity'}, {'measure': 'To evaluate the antitumor response according to the RECIST criteria', 'timeFrame': '21-day cycles until documented disease progression or unacceptable toxicity'}, {'measure': 'To evaluate the duration of achieved responses', 'timeFrame': '21-day cycles until documented disease progression or unacceptable toxicity'}, {'measure': 'To evaluate time to progression (TTP)', 'timeFrame': '21-day cycles until documented disease progression or unacceptable toxicity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 20 years or older\n* Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination\n\nExclusion Criteria:\n\n* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2'}, 'identificationModule': {'nctId': 'NCT01027208', 'briefTitle': 'A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline', 'organization': {'class': 'INDUSTRY', 'fullName': 'R-Pharm'}, 'officialTitle': 'A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline And Who Are Taxane Resistant Who Have Completed Study CA163107 And Who Are Benefiting From Continuation On Therapy With Ixabepilone', 'orgStudyIdInfo': {'id': 'CA163-130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ixabepilone', 'interventionNames': ['Drug: Ixabepilone']}], 'interventions': [{'name': 'Ixabepilone', 'type': 'DRUG', 'otherNames': ['Ixempra'], 'description': 'Lyophilized and solvent, IV, 10-50 mg/m²', 'armGroupLabels': ['Ixabepilone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '464-8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '277-0882', 'city': 'Kashiwa-Shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Local Institution'}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '371-8511', 'city': 'Matabashi-Shi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '892-0833', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '259-1193', 'city': 'Isehara-Shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '951-8566', 'city': 'Niigata', 'state': 'Niigata', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '350-0495', 'city': 'Iruma-Gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Local Institution'}, {'city': 'Saitama', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '320-0834', 'city': 'Utsunomiya', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.56667, 'lon': 139.88333}}, {'zip': '113-8677', 'city': 'Bunkyo-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '104-0045', 'city': 'Chuo-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}, {'city': 'Tokyo', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '170-8455', 'city': 'Toshima-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R-Pharm', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}