Clinical trial · Interventional
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
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Asian Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib
NCT01108705CI-TRIAL-00019428BRISK-APSterminatedPhase 3ClinicalTrials.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 determine whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brivanib | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Brivanib
- interventionNames
- Drug: Brivanib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- 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
- timeFrame
- Every 6 weeks for an average of 6 months
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Diagnosis of advanced hepatocellular carcinoma * 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 Key Exclusion Criteria: * Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.