BRISK - FL

A Randomized, Double-blind, Multi-center Phase III Study of Brivanib versus Sorafenib as First-line Treatment in Patients with Advanced Hepatocellular Carcinoma - CA182-033

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000276

Enrollment

1714

Registered

2010-11-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Advanced Hepatocellular Carcinoma

Interventions

Intervention1: Brivanib : Active Comparator: Drug: Brivanib Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity Drug: Placebo Capsules, Oral, twice Daily, Until di

Eligibility

Inclusion criteria

Inclusion criteria: Histologic or cytologic confirmed diagnosis of HCC. Advanced HCC Disease not eligible for surgical and / or locoregional therapies 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

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 Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 4 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 Timepoint: Time Frame: Survival will be assessed continuously Designated as safety issue: No	—

Secondary

Measure	Time frame
To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria To determine duration of response, duration of disease control, and time to response (TTR) To assess the safety profile of brivanib and sorafenib To explore PK and exposure-response in the study population To compare time to symptomatic progression To compare health-related quality of life Timepoint: Time frame for every secondary outcome is 6 weeks. Designated as safety issue: No	—

Measure

Time frame

To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria To determine duration of response, duration of disease control, and time to response (TTR) To assess the safety profile of brivanib and sorafenib To explore PK and exposure-response in the study population To compare time to symptomatic progression To compare health-related quality of life Timepoint: Time frame for every secondary outcome is 6 weeks. Designated as safety issue: No

—

Countries

Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, India, Italy, Japan, Mexico, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States of America

Contacts

Public ContactMsShivkumar Subashri

poonam.rohira@bms.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026