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The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm: Brivanib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivanib | Drug | Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of Brivanib | Days 1, 2, 8, 9 and 15 | |
| Trough observed plasma concentration (Cmin) of Brivanib | Days 1, 2, 8, 9 and 15 | |
| Time of maximum observed plasma concentration (Tmax) of Brivanib | Days 1, 2, 8, 9 and 15 | |
| Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib | Days 1, 2, 8, 9 and 15 | |
| Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib | Days 1, 2, 8, 9 and 15 | |
| Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib | Days 1, 2, 8, 9 and 15 | |
| Terminal half-life (T-HALF) of Brivanib | Days 1, 2, 8, 9 and 15 | |
| 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 | Days 1, 2, 8, 9 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | |
| 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 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Subjects with:
Exclusion Criteria:
Subjects with:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Beijing | Beijing Municipality | 100071 | China | ||
| Local Institution |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C509922 | brivanib |
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| Screening, Week 7 and every 6 weeks up to End of treatment (approximately 24 months) |
| Harbin |
| Heilongjiang |
| 150040 |
| China |
| Local Institution | Nanjing | Jiangsu | 210002 | China |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |