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)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00825955Tipo: INTERVENTIONALInicio: 17 de feb de 2009Fin estimado: 25 de ago de 2017

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
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

Criterios de exclusión

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)

Intervenciones

drug

Brivanib

Tablets, Oral, 800 mg, once daily, until disease progression or toxicity

other

Placebo

Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

procedure

Best Supportive Care

Trans-Arterial Chemo-Embolization (TACE) Therapy

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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