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
NCT ID: NCT01108705
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
87 participants
INTERVENTIONAL
2010-05-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Brivanib
Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Placebo
Placebo
Tablets, Oral, 0mg, once daily, until disease progression or toxicity
Interventions
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Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Placebo
Tablets, Oral, 0mg, once daily, until disease progression or toxicity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Asian ethnicity
* Patient has failed ≥14 days of sorafenib treatment
* Cirrhotic status of Child-Pugh Class A or B with a score of 7
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2
* Life expectancy of at least 8 weeks
* Adequate hematologic, hepatic, and renal function
Exclusion Criteria
* Previous or concurrent cancer that is distinct in primary site
* History of active cardiac disease
* Thrombotic or embolic events within the past 6 months
* Inability to swallow tablets or untreated malabsorption syndrome
* History of HIV infection
* Prior use of systemic investigational agents for hepatocellular carcinoma (except sorafenib)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Hefei, Anhui, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Chongqing, Chongqing Municipality, China
Local Institution
Fuzhou, Fujian, China
Local Institution
Fuzhou, Fujian, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Guanzhou, Guangdong, China
Local Institution
Harbin, Heilongjiang, China
Local Institution
Hankou, Hubei, China
Local Institution
Wuhan, Hubei, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Suzhou, Jiangsu, China
Local Institution
Changchun, Jilin, China
Local Institution
Changchun, Jilin, China
Local Institution
Shenyang, Liaoning, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Chengdu, Sichuan, China
Local Institution
Tianjin, Tianjin Municipality, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Xi'an, , China
Local Institution
Xi'an, , China
Local Institution
Singapore, , Singapore
Local Institution
Gyeonggi-do, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Kaohsiung County, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taoyuan District, , Taiwan
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CA182-047
Identifier Type: -
Identifier Source: org_study_id
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