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This is a Phase 2, Open-label, Randomized, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Brivanib in Patients with Previously Treated Advanced Hepatocellular Carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivanib 800 mg, QD + BSC | Experimental |
| |
| Brivanib 400 mg, BID + BSC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivanib 800 mg, QD | Drug | Brivanib Alaninate 800 mg QD, PO |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) at 3 months from randomization | Defined as the percentage of patients with complete response, partial response, or stable disease at 12 weeks from randomization by RECIST v1.1. | 12 weeks from randomization |
| Time to Progress (TTP) | Defined as the time from random assignment to radiologic disease progression. | 12 weeks from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) at 6 months from randomization | Defined as the percentage of patients with complete response, partial response, or stable disease at 24 weeks from randomization by RECIST v1.1. | 24 weeks from randomization |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | China | |||
| Nanfang Hospital |
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| Brivanib 400 mg, BID |
| Drug |
Brivanib Alaninate 400 mg BID, PO |
|
Defined as the time from random assignment until the date of disease progression or death as a result of any cause. |
| 24 weeks from randomization |
| Objective response rate (ORR) | Defined as the proportion of randomized patients with CR or PR as the optimal response in each treatment group assessed by use of RECIST 1.1 criteria | 24 weeks from randomization |
| Overall survival (OS) | Refers to the duration from randomization to death from any cause | 24 weeks from randomization |
| Guangzhou |
| Guangdong |
| China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| Hunan Cancer Hospital | Changsha | Hunan | China |
| China PLA 81st hospital | Nanjing | Jiangsu | China |
| The first Hospital of Jilin University | Changchun | Jilin | China |
| Army General Hospital of Shenyang military region | Shenyang | Liaoning | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | China |
| Zhongshan Hospital | Shanghai | Shanghai Municipality | China |
| Tangdu Hospital | Xi’an | Shanxi | China |
| West China Hospital West China School of Medicine Sichuan University | Chengdu | Sichuan | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China |
| 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 |
| C494814 | BID protein, human |
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