Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
Study NCT ID:
NCT00073112
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 Renal Cell Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital 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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2006-09', '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 RCC', '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': ['Renal Cell 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 renal cell 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* Renal Cell Carcinoma.\n* Recurrent tumor.\n* At least 6 weeks post-nephrectomy.\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': 'NCT00073112', 'briefTitle': 'A Study of ABT-751 in Patients With Renal Cell Cancer', 'nctIdAliases': ['NCT00080717'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma', 'orgStudyIdInfo': {'id': 'M02-416'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ABT-751', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Research Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90640', 'city': 'Montebello', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials + Research Associates', 'geoPoint': {'lat': 34.00946, 'lon': -118.10535}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'US Oncology Inc Rocky Mountain Cancer Centers', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Oncology Hematology Group of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'US Oncology Inc Florida Cancer Institute', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'US Oncology Inc Ocala Oncology Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'US Oncology Inc Cancer Centers of Florida, P.A.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60637-1471', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'US Oncology Inc Raleigh Hematology Oncology Clinic', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '45409', 'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'US Oncology Inc Dayton Oncology & Hematology P.A.', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'US Oncology Inc Cancer Care Accociates-Mercy Campus', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'US Oncology Inc 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}}, {'zip': '37232-6307', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'US Oncology Inc Tyler Cancer Center', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '99218', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'US Oncology Inc Cancer Care Northwest-North', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98684', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'US Oncology Inc Northwest Cancer Specialists', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'zip': 'V5Z 4E6CAN', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'B.C. Vancouver Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Science Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Helen Eliopoulos, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}}}}