Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT01108705
Status:
TERMINATED
Last Update Posted:
2015-10-12
First Post:
2010-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Brivanib and Best Supportive Care (BSC) With Placebo and BSC for Treatment of Liver Cancer in Asian Patients Who Have Failed Sorafenib Treatment
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2010-04-15', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2010-04-21', 'dispFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to sorafenib and receive brivanib plus best supportive care (BSC) to those receiving placebo plus BSC', 'timeFrame': 'Every 6 weeks for an average of 6 months'}], 'secondaryOutcomes': [{'measure': 'Compare time to progression (TTP) using modified RECIST for HCC', 'timeFrame': 'Every 6 weeks'}, {'measure': 'Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC', 'timeFrame': 'Every 6 weeks'}, {'measure': 'Assess duration of response, duration of disease control and time to response', 'timeFrame': 'Every 6 weeks'}, {'measure': 'Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results', 'timeFrame': 'Every 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Carcinoma, Hepatocellular']}, '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 determine whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of advanced hepatocellular carcinoma\n* Asian ethnicity\n* Patient has failed ≥14 days of sorafenib treatment\n* Cirrhotic status of Child-Pugh Class A or B with a score of 7\n* Eastern Cooperative Oncology Group performance status of 0, 1, or 2\n* Life expectancy of at least 8 weeks\n* Adequate hematologic, hepatic, and renal function\n\nKey Exclusion Criteria:\n\n* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy\n* Previous or concurrent cancer that is distinct in primary site\n* History of active cardiac disease\n* Thrombotic or embolic events within the past 6 months\n* Inability to swallow tablets or untreated malabsorption syndrome\n* History of HIV infection\n* Prior use of systemic investigational agents for hepatocellular carcinoma (except sorafenib)'}, 'identificationModule': {'nctId': 'NCT01108705', 'acronym': 'BRISK-APS', 'briefTitle': 'Comparison of Brivanib and Best Supportive Care (BSC) With Placebo and BSC for Treatment of Liver Cancer in Asian Patients Who Have Failed Sorafenib Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Asian Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib', 'orgStudyIdInfo': {'id': 'CA182-047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brivanib', 'interventionNames': ['Drug: Brivanib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Brivanib', 'type': 'DRUG', 'otherNames': ['BMS-582664'], 'description': 'Tablets, Oral, 800 mg, once daily, until disease progression or toxicity', 'armGroupLabels': ['Brivanib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0mg, once daily, until disease progression or toxicity', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230022', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, 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'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '710000', 'city': "Xi'an", 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710038', 'city': "Xi'an", 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '308433', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Local Institution', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '410-769', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '833', 'city': 'Kaohsiung County', 'country': 'Taiwan', 'facility': 'Local Institution'}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Local Institution', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}