This trial is active, not recruiting.

Condition liver cancer
Treatments brivanib, placebo, best supportive care
Phase phase 3
Sponsor Bristol-Myers Squibb
Start date February 2009
End date November 2011
Trial size 414 participants
Trial identifier NCT00825955, CA182-034, EUDRACT #: 2008-005084-34


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
brivanib BMS-582664
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
best supportive care
Trans-Arterial Chemo-Embolization (TACE) Therapy
(Placebo Comparator)
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
best supportive care
Trans-Arterial Chemo-Embolization (TACE) Therapy

Primary Outcomes

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
time frame: computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death

Secondary Outcomes

To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria)
time frame: 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
time frame: 35 months
To assess duration of response, duration of disease control and time to response
time frame: 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
time frame: 35 months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.