Liver Cancer
Conditions
Brief summary
The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib
Interventions
OTHERPlacebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
PROCEDUREBest Supportive Care
Trans-Arterial Chemo-Embolization (TACE) Therapy
DRUGBrivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Sponsors
Bristol-Myers Squibb
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
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. 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
* 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 |
|---|---|
| To 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 | computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death |
Secondary
| Measure | Time frame |
|---|---|
| To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria) | 35 months |
| To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria | 35 months |
| To assess duration of response, duration of disease control and time to response | 6 weeks |
| To assess safety profile of brivanib. Safety will be assessed by the number of adverse events (AEs), serious adverse events (SAEs), periodic data monitoring committee (DMC) review | 35 months |
Countries
Argentina, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, India, Italy, Japan, Mexico, Puerto Rico, Russia, South Korea, Spain, Taiwan, United States
Outcome results
None listed