Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-29 @ 6:39 PM
Study NCT ID:
NCT00708006
Status:
COMPLETED
Last Update Posted:
2013-11-07
First Post:
2008-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of HGS1029 (AEG40826-2HCl) in Subjects With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2008-06-30', 'studyFirstSubmitQcDate': '2008-06-30', 'lastUpdatePostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks', 'timeFrame': 'throughout the study'}], 'secondaryOutcomes': [{'measure': 'Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity', 'timeFrame': 'throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of HGS1029 in subjects with advanced solid tumors and to determine a phase 2 dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed advanced solid malignancy\n* Life expectancy of at least 3 months\n* Age 18 years or older\n* Acceptable liver function\n* Acceptable renal function\n* Acceptable hematologic status\n\nExclusion Criteria:\n\n* Received investigational (not yet approved by a regulatory authority)agent within 4 weeks before enrollment.\n* Received non-investigational agent within 3 weeks before enrollment.\n* Progressive CNS involvement including the need of corticosteroids\n* Pregnant or breast-feeding women\n* Active, uncontrolled bacterial, viral, or fungal infections within 2 weeks of Cycle 1 Day 1\n* Known HIV infection'}, 'identificationModule': {'nctId': 'NCT00708006', 'briefTitle': 'A Study of HGS1029 (AEG40826-2HCl) in Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Human Genome Sciences Inc.'}, 'officialTitle': 'A Phase 1 Dose-Escalation Study to Evaluate the Safety and Tolerability of HGS1029 (AEG40826-2HCl) in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'HGS1029-C1078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'HGS1029', 'interventionNames': ['Drug: HGS1029']}], 'interventions': [{'name': 'HGS1029', 'type': 'DRUG', 'otherNames': ['AEG40826•2HCl'], 'description': 'Escalating doses by IV (in the vein), on days 1, 8 and 15 of each 28-day cycle. Number of cycles: until disease progression or unacceptable toxicity', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Dept. of Medicine-Oncology', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Sciences Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Gilles Gallant, B. Pharm.,Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Human Genome Sciences Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Human Genome Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}