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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01108705

Acronym

BRISK-APS

Enrollment

Registered

2010-04-22

Start date

2010-05-31

Completion date

2013-10-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

Brief summary

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.

Interventions

DRUGBrivanib

Tablets, Oral, 800 mg, once daily, until disease progression or toxicity

DRUGPlacebo

Tablets, Oral, 0mg, once daily, until disease progression or toxicity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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)

Design outcomes

Primary

Measure	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

Secondary

Measure	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
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

Countries

China, Singapore, South Korea, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026