First Line Hepato Cellular Carcinoma (HCC)

Phase 3

Completed

• Conditions: Hepato Cellular Carcinoma (HCC)
• Interventions: Drug: Sorafenib; Drug: Brivanib; Drug: Placebo

• Registration Number: NCT00858871
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Study Start: 2009-05
• Primary Completion: 2012-06
• Study Completion: 2013-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Disposition First Posted: 2015-10-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1714

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sorafenib	Placebo	-
Sorafenib	Sorafenib	-
Brivanib	Brivanib	-
Brivanib	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To compare the time to progression (TTP) (investigator assessed 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 explore PK and exposure-response in the study population	Every 6 weeks
To compare time to symptomatic progression	Every 6 weeks
To compare health-related quality of life	Every 6 weeks
To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC	Every 6 weeks

Trial Locations

Locations (13)

Agajanian Institute Of Hematology And Oncology; 🇺🇸 Downey, California, United States

Sharp Clinical Oncology Research; 🇺🇸 San Diego, California, United States

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

Thomas Jefferson Univ.; 🇺🇸 Philadelphia, Pennsylvania, United States

Mcguire Dvamc; 🇺🇸 Richmond, Virginia, United States

Local Institution; 🇬🇧 Leeds, Yorkshire, United Kingdom

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

Univ Of Ark For Med Sci; 🇺🇸 Little Rock, Arkansas, United States

Va Ct Healthcare System; 🇺🇸 West Haven, Connecticut, United States

Medical Specialists Of Palm Beaches; 🇺🇸 Lake Worth, Florida, United States

3912 Taubman Center; 🇺🇸 Ann Arbor, Michigan, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

University Of Wisconsin; 🇺🇸 Madison, Wisconsin, United States