Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT00063102
Status:
COMPLETED
Last Update Posted:
2007-11-29
First Post:
2003-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.
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': 'C490492', 'term': 'ABT751'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-28', 'studyFirstSubmitDate': '2003-06-19', 'studyFirstSubmitQcDate': '2003-06-20', 'lastUpdatePostDateStruct': {'date': '2007-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate in subjects with Breast cancer', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Time to Tumor Progression (TTP)', 'timeFrame': '1 year'}, {'measure': 'Survival', 'timeFrame': '2 years'}, {'measure': 'Toxicities associated with treatment administration', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Stage IIIB or IV breast cancer.\n* Recurrent tumor after or while on taxane therapy (taxol or taxotere).\n* Able to tolerate normal activities of daily living.\n* Adequate bone marrow, kidney and liver function.\n\nExclusion Criteria\n\n* Pregnant or breast feeding.\n* No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration.'}, 'identificationModule': {'nctId': 'NCT00063102', 'briefTitle': 'A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase II Study of ABT-751 in Patients With Breast Cancer Refractory to Taxane Regimens', 'orgStudyIdInfo': {'id': 'M02-447'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ABT-751', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Oncology-Hematology Group of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Network, Inc.', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Cancer Specialists', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Medical School Division of Hematology/Oncology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center Section of of Hemtology/Oncology Indiana Cancer Pavilion', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Northern Indiana Cancer Research Consortium', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Oncology & Hemotology Associates of Kansas City, PA', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Helen Eliopoulos, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}}}}