Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT00517920
Status:
COMPLETED
Last Update Posted:
2013-01-04
First Post:
2007-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'Hong Kong']}, 'interventionBrowseModule': {'meshes': [{'id': 'C513486', 'term': 'linifanib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2012-06-29', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-02', 'studyFirstSubmitDate': '2007-08-16', 'dispFirstSubmitQcDate': '2012-06-29', 'studyFirstSubmitQcDate': '2007-08-16', 'dispFirstPostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Rate', 'timeFrame': 'Week 16'}, {'measure': 'Objective Response Rate', 'timeFrame': 'Week 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)', 'detailedDescription': 'An Open-label, Phase 2 study of efficacy and tolerability of ABT-869 in advanced hepatocellular carcinoma (HCC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Subject must be greater than or equal to 18 years of age\n* Subject must be diagnosed with unresectable or metastatic HCC\n* Subjects must have a measurable lesion by RECIST on CT scan in at least one site which has not received radiation\n* Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2\n* No other active malignancy within the past 5 years\n\nExclusion Criteria\n\n* Subject has received targeted VEGF/PDGF/TKI therapy. Prior Avastin is allowed\n* Subject has Child-Pugh grade Class C hepatic impairment\n* The subject has proteinuria Common Toxicity Criteria (CTC) grade \\> 1 as measured by routine urinalysis or 24 hour urine collection during screening assessment\n* Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure \\> 100 mmHg or systolic blood pressure \\> 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention\n* The subject has a documented left ventricular Ejection Fraction \\< 50%\n* Subject is receiving therapeutic anticoagulation therapy'}, 'identificationModule': {'nctId': 'NCT00517920', 'briefTitle': 'Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'An Open-Label, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)', 'orgStudyIdInfo': {'id': 'M06-879'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABT-869', 'interventionNames': ['Drug: ABT-869']}], 'interventions': [{'name': 'ABT-869', 'type': 'DRUG', 'description': '0.25 mg/kg QD', 'armGroupLabels': ['ABT-869']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 7726', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Site Reference ID/Investigator# 7169', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'country': 'Canada', 'facility': 'Site Reference ID/Investigator# 5837', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': '119228', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Site Reference ID/Investigator# 5235', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Site Reference ID/Investigator# 5611', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Site Reference ID/Investigator# 6265', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Justin Ricker, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}