Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT01264705
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2010-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547825', 'term': 'bavituximab'}, {'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adam.yopp@utsouthwestern.edu', 'phone': '214-648-5870', 'title': 'Adam Yopp, MD', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1', 'description': 'Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2', 'description': 'Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 3', 'description': 'Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 12, 'seriousNumAtRisk': 41, 'deathsNumAffected': 38, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'abdominal cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'Hand /foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'Gerd', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'Upper gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'stomstitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'infusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'hiccoughs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 4.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Radiographic Time to Progression (TTP) Calculated From Treatment Initiation to First Evidence of Disease Progression or Last Follow-up.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '16.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Treatment initiation to first evidence of disease progression or last follow-up, an average of 24 months', 'description': "Median radiographic time to progression (TTP) was calculated from treatment initiation to first evidence of disease progression or last follow-up by using the Kaplan-Meier method. The 95% confidence intervals (CIs) for time-to-progression data was calculated using Greenwood's formula.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 1 and 2 were part of phase 1 study and at the phase 1 study this outcome was not collected. The 3 participants who received dose Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily were part of phase 1 and hence they were not part of phase 2 . Hence their data were not analyzed here.'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Dose Limiting Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bavituximab:0.3 mg/kg Weekly Sorafenib: 400mg PO Twice Daily', 'description': 'Cohort 1: Participants were administered Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily\n\nbavituximab (0.3 mg/kg) and sorafenib: Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'OG001', 'title': 'Bavituximab: 1.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily', 'description': 'Cohort 2: Participants were administered Bavituximab:1.0 mg/kg weekly Sorafenib: 400mg PO twice daily\n\nbavituximab (1.0 mg/kg ) and sorafenib: Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'OG002', 'title': 'Bavituximab: 3.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily', 'description': 'Cohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily\n\nbavituximab (3.0 mg/kg) and sorafenib: Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 months.', 'description': 'Dose limiting toxicity by serious adverse events by CTCAE version 4.0', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was for phase 1 only'}, {'type': 'SECONDARY', 'title': 'Safety, as Measured by the Number of Patients With Adverse Event Related to the Treatment That Experienced Grade 3 or Greater.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 months of patient enrollment (phase 1)', 'description': 'Safety was measured by the number of patients with at least one adverse event as assess by NCI Common Terminology criteria for adverse events (CTCAE)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was only analyzed for phase 1'}, {'type': 'SECONDARY', 'title': 'Median Months of Overall Survival Calculated From Treatment Initiation to Death or Last Follow-up.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG002', 'lowerLimit': '4.9', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Treatment initiation to death or last follow-up, an average 24 months', 'description': "Median months of overall survival was calculated from treatment initiation to death or last follow-up by using the Kaplan-Meier method. 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Hence their data were not analyzed here.'}, {'type': 'SECONDARY', 'title': 'Median Months of Disease Specific Survival Calculated From Treatment Initiation to Death From Advanced HCC (Hepatocellular Carcinoma) or Last Follow-up.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '13.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Treatment initiation to first evidence of death from advanced liver cancer or last follow-up, an average of 12 months', 'description': "Median months of disease specific survival was calculated from treatment initiation to first evidence of death from advanced liver cancer or last follow-up by using the Kaplan-Meier method. The 95% confidence intervals (CIs) for time-to-disease specific survival data was calculated using Greenwood's formula.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 1 and 2 were part of phase 1 study and at the phase 1 study this outcome was not collected. The 3 participants who received dose Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily were part of phase 1 and hence they were not part of phase 2 . Hence their data were not analyzed here.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bavituximab:0.3 mg/kg Weekly Sorafenib: 400mg PO Twice Daily', 'description': 'Cohort 1: Participants were administered Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'FG001', 'title': 'Bavituximab: 1.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily', 'description': 'Cohort 2: Participants were administered Bavituximab:1.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'FG002', 'title': 'Bavituximab: 3.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily', 'description': 'Cohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Bavituximab:0.3 mg/kg Weekly Sorafenib: 400mg PO Twice Daily', 'description': 'Cohort 1: Participants were administered Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'BG001', 'title': 'Bavituximab: 1.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily', 'description': 'Cohort 2: Participants were administered Bavituximab:1.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'BG002', 'title': 'Bavituximab: 3.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily', 'description': 'Cohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-05', 'size': 2035229, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-13T12:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-22', 'studyFirstSubmitDate': '2010-12-01', 'resultsFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2010-12-21', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-22', 'studyFirstPostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Radiographic Time to Progression (TTP) Calculated From Treatment Initiation to First Evidence of Disease Progression or Last Follow-up.', 'timeFrame': 'Treatment initiation to first evidence of disease progression or last follow-up, an average of 24 months', 'description': "Median radiographic time to progression (TTP) was calculated from treatment initiation to first evidence of disease progression or last follow-up by using the Kaplan-Meier method. The 95% confidence intervals (CIs) for time-to-progression data was calculated using Greenwood's formula."}, {'measure': 'Number of Patients With Dose Limiting Toxicity', 'timeFrame': '8 months.', 'description': 'Dose limiting toxicity by serious adverse events by CTCAE version 4.0'}], 'secondaryOutcomes': [{'measure': 'Safety, as Measured by the Number of Patients With Adverse Event Related to the Treatment That Experienced Grade 3 or Greater.', 'timeFrame': 'Up to 3 months of patient enrollment (phase 1)', 'description': 'Safety was measured by the number of patients with at least one adverse event as assess by NCI Common Terminology criteria for adverse events (CTCAE)'}, {'measure': 'Median Months of Overall Survival Calculated From Treatment Initiation to Death or Last Follow-up.', 'timeFrame': 'Treatment initiation to death or last follow-up, an average 24 months', 'description': "Median months of overall survival was calculated from treatment initiation to death or last follow-up by using the Kaplan-Meier method. The 95% confidence intervals (CIs) for median months of overall survival was calculated using Greenwood's formula."}, {'measure': 'Median Months of Disease Specific Survival Calculated From Treatment Initiation to Death From Advanced HCC (Hepatocellular Carcinoma) or Last Follow-up.', 'timeFrame': 'Treatment initiation to first evidence of death from advanced liver cancer or last follow-up, an average of 12 months', 'description': "Median months of disease specific survival was calculated from treatment initiation to first evidence of death from advanced liver cancer or last follow-up by using the Kaplan-Meier method. The 95% confidence intervals (CIs) for time-to-disease specific survival data was calculated using Greenwood's formula."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cirrhosis', 'GI Cancer', 'Hepatitis', 'Oncology'], 'conditions': ['Hepatocellular Carcinoma', 'Liver Cancer']}, 'referencesModule': {'references': [{'pmid': '31429027', 'type': 'DERIVED', 'citation': 'Mokdad AA, Zhu H, Beg MS, Arriaga Y, Dowell JE, Singal AG, Yopp AC. Efficacy and Safety of Bavituximab in Combination with Sorafenib in Advanced Hepatocellular Carcinoma: A Single-Arm, Open-Label, Phase II Clinical Trial. Target Oncol. 2019 Oct;14(5):541-550. doi: 10.1007/s11523-019-00663-3.'}]}, 'descriptionModule': {'briefSummary': 'This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This study will be activated at the UT Southwestern Medical Center, comprised of The Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland Memorial Hospital System. Advanced HCC is defined as disease that is not amenable to surgical resection or orthotopic liver transplantation or is metastatic in nature.', 'detailedDescription': 'The investigators are looking for men or women aged 18 years or older with hepatocellular carcinoma not suitable for surgical resection or hepatic transplantation. Prior locoregional therapy including but not limited to transarterial chemoembolization (TACE), radiofrequency ablation (RFA) or ethanol injection is allowed as long as the treatment was 4 weeks previous. Patients must be Child-Pugh A with no previous treatment with sorafenib or other vascular endothelial growth factor (VEGF) inhibitors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:\n\n * Histologically confirmed.\n * MRI or CT consistent with liver cirrhosis and at least one solid liver lesion \\>2 cm with early enhancement and delayed enhancement washout regardless of AFP.\n * AFP \\>400 ng/ml and evidence of at least one solid liver lesion \\>2 cm regardless of specific imaging characteristics on CT or MRI.\n2. Locally advanced or metastatic disease.\n3. Patients with locally advanced disease must have disease deemed to be unresectable or not eligible for hepatic transplantation. Determination will occur in the weekly GI DMT meeting by surgical oncologists and transplant surgeons.\n4. Measurable disease, as defined as lesions that can accurately be measured in at least one dimension (longest diameter to be measured) according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at least 2 cm with conventional techniques or at least 1 cm with spiral computed tomography.\n5. Child-Pugh Score A.\n6. Age ≥ 18 years.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.\n8. Absolute neutrophil count ≥ 1,500 cells/mm3.\n9. Platelet count ≥ 75,000 cells/mm3.\n10. Total bilirubin ≤ 3.0 mg/dl.\n11. Hemoglobin ≥ 8.5 g/dl.\n12. AST and ALT ≤ 5.0 times upper limit of normal.\n13. D-dimer ≤ 3 times upper limit of normal.\n14. INR ≤ 1.8 (therapeutic anticoagulation allowed as long as medically indicated.\n\nExclusion Criteria:\n\n1. History of bleeding diathesis or coagulopathy.\n2. Symptomatic or clinically active brain metastases.\n3. Major surgery within previous 4 weeks.\n4. History of thromboembolic events (including both pulmonary embolisms and deep vein thrombosis); central venous catheter-related thrombosis \\> 6 months prior is allowed.\n5. Prior adjuvant therapy with sorafenib or other Raf/MEK/RAS or VEGFR inhibitors. Prior adjuvant therapy is allowed provided it was completed \\> 6 months ago and there is documented recurrence of hepatocellular carcinoma.'}, 'identificationModule': {'nctId': 'NCT01264705', 'briefTitle': 'Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'A Phase I/II Study of Bavituximab and Sorafenib In Patients With Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'STU 062010-150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily', 'description': 'Cohort 1: Participants were administered Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily', 'interventionNames': ['Drug: bavituximab (0.3 mg/kg) and sorafenib']}, {'type': 'EXPERIMENTAL', 'label': 'Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily', 'description': 'Cohort 2: Participants were administered Bavituximab:1.0 mg/kg weekly Sorafenib: 400mg PO twice daily', 'interventionNames': ['Drug: bavituximab (1.0 mg/kg ) and sorafenib']}, {'type': 'EXPERIMENTAL', 'label': 'Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily', 'description': 'Cohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily', 'interventionNames': ['Drug: bavituximab (3.0 mg/kg) and sorafenib']}], 'interventions': [{'name': 'bavituximab (0.3 mg/kg) and sorafenib', 'type': 'DRUG', 'description': 'Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily', 'armGroupLabels': ['Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily']}, {'name': 'bavituximab (1.0 mg/kg ) and sorafenib', 'type': 'DRUG', 'description': 'Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily', 'armGroupLabels': ['Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily']}, {'name': 'bavituximab (3.0 mg/kg) and sorafenib', 'type': 'DRUG', 'description': 'Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily', 'armGroupLabels': ['Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Adam C Yopp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Adam Yopp', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}