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A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Liver Cancer

Thank you

Trial Information

A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)


Inclusion Criteria:



- Histologic or cytologic confirmed diagnosis of HCC

- Advanced disease defined as (i) disease not eligible for surgical or loco-regional
therapy or (ii) disease progressive after surgical or loco-regional therapy

- Patient has failed ≥ 14 days of Sorafenib treatment

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

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

- Subjects who have a life expectancy of at least 8 weeks

- Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

- women of childbearing potential (WOCBP) who are unwilling or unable to use an
acceptable method to avoid pregnancy

- Previous or concurrent cancer that is distinct in primary site

- History of active cardiac disease

- Thrombotic or embolic events within the past 6 months

- Any other hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events
(CTCAE) Grade 3 within 4 weeks

- Inability to swallow tablets or untreated malabsorption syndrome

- History of human immunodeficiency virus (HIV) infection

- Prior use of systemic investigational agents for HCC (except for Sorafenib)

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 overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to Sorafenib and receive Brivanib plus best supportive care (BSC) to those receiving placebo plus BSC

Outcome Time Frame:

computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Brazil: Ministry of Health

Study ID:

CA182-034

NCT ID:

NCT00825955

Start Date:

February 2009

Completion Date:

September 2012

Related Keywords:

  • Liver Cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Mayo ClinicRochester, Minnesota  55905
Mount Sinai School of MedicineNew York, New York  10029
James Graham Brown Cancer CenterLouisville, Kentucky  40202
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
3912 Taubman CenterAnn Arbor, Michigan  48109-0362
Ohio State UniversityColumbus, Ohio  43210
McGuire DVAMCRichmond, Virginia  23249
Pacific Hematology Oncology AssociatesSan Francisco, California  94115
Sharp Clinical Oncology ResearchSan Diego, California  92123
Henry Ford Health System IrbDetroit, Michigan  48202
Mayo Clinic ArizonaScottsdale, Arizona  85259
Columbia University Medical CenterNew York, New York  10032
Loma Linda University Cancer CenterLoma Linda, California  92354
Oregon Health & Sci UnivPortland, Oregon  97239
Univ Of Ark For Med SciLittle Rock, Arkansas  72205
Richard Finn, M.D.Los Angeles, California  90095
University Of Florida HepatologyGainesville, Florida  32610
The University Of Texas Medical School At HoustonHouston, Texas  77030
The University Of Texas Health Science CenterSan Antonio, Texas  78229