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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivanib | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivanib | Drug | Tablets, Oral, 800 mg, once daily, until disease progression or toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Every 6 weeks for an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare time to progression (TTP) using modified RECIST for HCC | Every 6 weeks | |
| Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC | Every 6 weeks | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Hefei | Anhui | 230022 | China | ||
| Local Institution |
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| Placebo | Drug | Tablets, Oral, 0mg, once daily, until disease progression or toxicity |
|
| Assess duration of response, duration of disease control and time to response |
| Every 6 weeks |
| Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results | Every 6 weeks |
| Beijing |
| Beijing Municipality |
| 100021 |
| China |
| Local Institution | Beijing | Beijing Municipality | 100071 | China |
| Local Institution | Beijing | Beijing Municipality | 100853 | China |
| Local Institution | Chongqing | Chongqing Municipality | 400038 | China |
| Local Institution | Fuzhou | Fujian | 350014 | China |
| Local Institution | Fuzhou | Fujian | 350025 | China |
| Local Institution | Guangzhou | Guangdong | 510060 | China |
| Local Institution | Guangzhou | Guangdong | 510515 | China |
| Local Institution | Guanzhou | Guangdong | 610080 | China |
| Local Institution | Harbin | Heilongjiang | 150040 | China |
| Local Institution | Hankou | Hubei | 430023 | China |
| Local Institution | Wuhan | Hubei | 430030 | China |
| Local Institution | Nanjing | Jiangsu | 210002 | China |
| Local Institution | Nanjing | Jiangsu | 210029 | China |
| Local Institution | Suzhou | Jiangsu | 215006 | China |
| Local Institution | Changchun | Jilin | 130012 | China |
| Local Institution | Changchun | Jilin | 130021 | China |
| Local Institution | Shenyang | Liaoning | 110001 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200032 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200080 | China |
| Local Institution | Chengdu | Sichuan | 610041 | China |
| Local Institution | Tianjin | Tianjin Municipality | 300060 | China |
| Local Institution | Hangzhou | Zhejiang | 310022 | China |
| Local Institution | Xi'an | 710000 | China |
| Local Institution | Xi'an | 710038 | China |
| Local Institution | Singapore | 308433 | Singapore |
| Local Institution | Gyeonggi-do | 410-769 | South Korea |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Kaohsiung County | 833 | Taiwan |
| Local Institution | Taipei | 11217 | Taiwan |
| Local Institution | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C509922 | brivanib |
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