Health Condition 1: null- Advanced Hepatocellular Carcinoma
Conditions
Interventions
Intervention1: Brivanib: Experimental,: Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Control Intervention1: Placebo: Placebo Comparator: Tablets, Oral, once daily, until di
Sponsors
Bristol-Myers Squibb India Pvt. Ltd.
'A' Wing , Shivasagar Estate, 1st Floor ,
Dr Annie Besant Road, Worli, Mumbai - 400 018
India
Eligibility
Inclusion criteria
Inclusion criteria: Histologic or cytologic confirmed diagnosis of HCC Advanced disease defined as (i) disease not eligible for surgical or loco-regional therapy or (ii) disease progressive after surgical or loco-regional therapy 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 (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
Exclusion criteria: •women of childbearing potential (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 •Any other hemorrhage/bleeding event Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures: 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 [ Designated as safety issue: No ]Timepoint: [ Time Frame: CT/MRI every six weeks until progression or death ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures: Compare time to progression (TTP) (Investigator assessed using modified WHO criteria) [ Designated as safety issue: No ] Compare investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified WHO criteria [ Designated as safety issue: No ] Assess duration of response, duration of disease control and time to response [ Designated as safety issue: No ] Assess safety profile of brivanib [ Designated as safety issue: Yes ]Timepoint: Secondary Outcome Measures: Compare time to progression (TTP) [Time Frame: 23 months ] Compare investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified WHO criteria [ Time Frame: 23 months ] Assess duration of response, duration of disease control and time to response [ Time Frame: 6 weeks ] Assess safety profile of brivanib [ Time Frame: 23 months ] [ Designated as safety issue: Yes ] | — |
Countries
India
Contacts
Public ContactMs Shivkumar Subashri
Disease Area Head
Outcome results
None listed