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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Hepatocellular

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Trial Information

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


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

- ECOG performance status 0,1,2

- Subjects who have a life expectancy of at least 8 weeks

- Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

- WOCBP 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 human immunodeficiency virus (HIV) infection

- Prior use of systemic investigational agents for HCC (except for Sorafenib)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome 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

Outcome Time Frame:

Every 6 weeks for an average of 6 months

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

China: Food and Drug Administration

Study ID:

CA182-047

NCT ID:

NCT01108705

Start Date:

January 2010

Completion Date:

September 2014

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular

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