Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-29 @ 1:52 PM
Study NCT ID:
NCT01540461
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2012-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509922', 'term': 'brivanib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-04', 'studyFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2012-02-27', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of Brivanib', 'timeFrame': 'Days 1, 2, 8, 9 and 15'}, {'measure': 'Trough observed plasma concentration (Cmin) of Brivanib', 'timeFrame': 'Days 1, 2, 8, 9 and 15'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) of Brivanib', 'timeFrame': 'Days 1, 2, 8, 9 and 15'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib', 'timeFrame': 'Days 1, 2, 8, 9 and 15'}, {'measure': 'Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib', 'timeFrame': 'Days 1, 2, 8, 9 and 15'}, {'measure': 'Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib', 'timeFrame': 'Days 1, 2, 8, 9 and 15'}, {'measure': 'Terminal half-life (T-HALF) of Brivanib', 'timeFrame': 'Days 1, 2, 8, 9 and 15'}, {'measure': 'Accumulation index calculated as the ratio: AUC(TAU) at steady-state (Day 8) divided by AUC(TAU) after the first dose (Day 1) [AI] of Brivanib', 'timeFrame': 'Days 1, 2, 8, 9 and 15'}], 'secondaryOutcomes': [{'measure': 'Safety assessments based on adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs), 2-D Echocardiograms, physical examinations and clinical laboratory tests', 'timeFrame': 'Part A: Day 1-Week 1, Day 8-Week 2, Day 15-Week 3 and Day 29-Week 5, Part B: End of treatment (approximately 24 months)'}, {'measure': 'Preliminary evidence of anti-tumor activity as measured by objective response rate (ORR) and disease control rate (DCR) in Chinese subjects with advanced HCC treated with Brivanib', 'timeFrame': 'Screening, Week 7 and every 6 weeks up to End of treatment (approximately 24 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HCC'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.\n\nInclusion Criteria:\n\nSubjects with:\n\n* Confirmed Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)\n* Not having received prior systemic treatment for advanced HCC\n* Normal or moderately impaired liver function (Child-Pugh Class A or B (CP total score of ≤ 7))\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\nExclusion Criteria:\n\nSubjects with:\n\n* Brain metastasis or evidence of leptomeningeal disease\n* History of impaired brain function (encephalopathy) or active heart disease\n* Unmanageable fluid in the abdomen (ascites)\n* Bleeding esophageal or gastric varices within 2 months prior to inclusion'}, 'identificationModule': {'nctId': 'NCT01540461', 'briefTitle': 'Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)', 'orgStudyIdInfo': {'id': 'CA182-064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm: Brivanib', 'interventionNames': ['Drug: Brivanib']}], 'interventions': [{'name': 'Brivanib', 'type': 'DRUG', 'otherNames': ['BMS-582664'], 'description': 'Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity', 'armGroupLabels': ['Arm: Brivanib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '150040', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}