Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00073151
Status:
COMPLETED
Last Update Posted:
2007-11-29
First Post:
2003-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of ABT-751 in Patients With 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': 'C490492', 'term': 'ABT751'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-28', 'studyFirstSubmitDate': '2003-11-17', 'studyFirstSubmitQcDate': '2003-11-17', 'lastUpdatePostDateStruct': {'date': '2007-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-11-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate in subjects with NSCLC', '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': ['Non-Small Cell Lung 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 non-small cell lung cancer. 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': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Stage IIIB or IV non-small cell lung cancer.\n* Recurrent tumor following treatment with paclitaxel or docetaxel.\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* Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.\n* CNS metastasis.'}, 'identificationModule': {'nctId': 'NCT00073151', 'briefTitle': 'A Study of ABT-751 in Patients With Non-Small Cell Lung Cancer', 'nctIdAliases': ['NCT00080730'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase II Study of ABT-751 in Patients With Non-Small Cell Lung Cancer Refractory to Taxane Regimens', 'orgStudyIdInfo': {'id': 'M02-448'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ABT-751', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Oncology Hematology Group of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Institute', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '60637-1460', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21201-1595', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Greenbaum Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Oncology & Hematology Associates of Kansas City, PA', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110-1093', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Regional Cancer Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Hematology Oncology', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dayton Oncology and Hematology', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Centers of the Carolinas', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'West Cancer Clinic', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Cancer Care Northwest', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Cancer Specialists', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'zip': '53792-5666', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Helen Eliopoulos, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}}}}