First Line Hepato Cellular Carcinoma (HCC)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepato Cellular Carcinoma (HCC)

In brief

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.

Key facts

Study ID

NCT00858871

Run by

Bristol-Myers Squibb

People needed

1714

Starts

2009-05-01

Expected to finish

2013-09-01

Last updated by the study team

2016-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Univ Of Ark For Med Sci — Little Rock, Arkansas, United States
• Agajanian Institute Of Hematology And Oncology — Downey, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• Va Ct Healthcare System — West Haven, Connecticut, United States
• Medical Specialists Of Palm Beaches — Lake Worth, Florida, United States
• James Graham Brown Cancer Center — Louisville, Kentucky, United States
• 3912 Taubman Center — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Thomas Jefferson Univ. — Philadelphia, Pennsylvania, United States
• Mcguire Dvamc — Richmond, Virginia, United States
• University Of Wisconsin — Madison, Wisconsin, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Caba, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Rosario, Santa Fe Province, Argentina
• Local Institution — Camperdown, New South Wales, Australia
• Local Institution — Concord, New South Wales, Australia
• Local Institution — Westmead Nsw, New South Wales, Australia
• Local Institution — Parkville, Victoria, Australia
• Local Institution — Prahan, Victoria, Australia
• Local Institution — Liège, Belgium
• Local Institution — Fortaleza, Ceará, Brazil
• Local Institution — Salvador, Estado de Bahia, Brazil
• Local Institution — Salvador - Ba, Estado de Bahia, Brazil
• Mayo Clinic Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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