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A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

Thank you

Trial Information

A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)


Inclusion Criteria:



- Patients with diagnosis of hepatocellular carcinoma

- Cirrhotic status of Child-Pugh Class A or B with a score of 7

- ECOG performance status of 0 or 1

- Adequate hematologic, hepatic, and renal function

Exclusion criteria:

- Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or
molecular targeted agents for HCC

- History of cardiac disease

- Active and untreated hepatitis B

- Inability to swallow tablets or untreated malabsorption syndrome

- History of human immunodeficiency virus (HIV) infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy

Outcome Time Frame:

Survival will be assessed continuously

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

CA182-037

NCT ID:

NCT00908752

Start Date:

February 1920

Completion Date:

March 2015

Related Keywords:

  • Hepatocellular Carcinoma
  • HCC
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Rhode Island HospitalProvidence, Rhode Island  02903
Montefiore Medical CenterBronx, New York  10467-2490
Seattle Cancer Care AllianceSeattle, Washington  98109
Sharp Clinical Oncology ResearchSan Diego, California  92123
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Virginia Health SystemCharlottesville, Virginia  22903
Richard Finn, M.D.Los Angeles, California  90095
The University Of Texas Medical School At HoustonHouston, Texas  77030
Vanderbilt University Med CtrNashville, Tennessee  37232