Clinical trial · Interventional
Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)
NCT01540461CI-TRIAL-00015027completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brivanib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm: Brivanib
- interventionNames
- Drug: Brivanib
Primary outcomes (8)
- measure
- Maximum observed plasma concentration (Cmax) of Brivanib
- timeFrame
- Days 1, 2, 8, 9 and 15
- measure
- Trough observed plasma concentration (Cmin) of Brivanib
- timeFrame
- Days 1, 2, 8, 9 and 15
- measure
- Time of maximum observed plasma concentration (Tmax) of Brivanib
- timeFrame
- Days 1, 2, 8, 9 and 15
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Subjects with: * Confirmed Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC) * Not having received prior systemic treatment for advanced HCC * Normal or moderately impaired liver function (Child-Pugh Class A or B (CP total score of ≤ 7)) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: Subjects with: * Brain metastasis or evidence of leptomeningeal disease * History of impaired brain function (encephalopathy) or active heart disease * Unmanageable fluid in the abdomen (ascites) * Bleeding esophageal or gastric varices within 2 months prior to inclusion
References
Publications (0)
Data not yet available
No reference posted for this study.