First Line Hepato Cellular Carcinoma (HCC)

A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00858871

Acronym

BRISK FL

Enrollment

1714

Registered

2009-03-10

Start date

2009-05-31

Completion date

2013-09-30

Last updated

2016-10-17

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

Conditions

Hepato Cellular Carcinoma (HCC)

Brief summary

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.

Interventions

DRUGBrivanib

Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity

DRUGPlacebo

Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity

DRUGSorafenib

Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable 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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Histologic or cytologic confirmed diagnosis of HCC. * Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies * Child-Pugh Class A * ECOG performance status 0-1 * Adequate hematologic, hepatic, and renal function

Exclusion criteria

* Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC * History of active cardiac disease * Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus) * Any other hemorrhage/bleeding event \>= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices * Inability to swallow tablets or untreated malabsorption syndrome

Design outcomes

Primary

Measure	Time frame
To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment	Survival will be assessed continuously

Secondary

Measure	Time frame
To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC	Every 6 weeks
To determine duration of response, duration of disease control, and time to response (TTR)	Every 6 weeks
To assess the safety profile of brivanib and sorafenib	Every 6 weeks
To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC	Every 6 weeks
To compare time to symptomatic progression	Every 6 weeks
To compare health-related quality of life	Every 6 weeks
To explore PK and exposure-response in the study population	Every 6 weeks

Countries

Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hong Kong, India, Italy, Japan, Mexico, Poland, Puerto Rico, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026