Trial Condition(s):

Carcinoma, Hepatocellular

A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma

Bayer Identifier:

10874

ClinicalTrials.gov Identifier:

NCT00044512

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.

Inclusion Criteria
- Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
- Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery 
- Measurable disease 
- At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography (CT) scan or magnetic resonance imaging (MRI) 
- Presence of at least 1 of the following: 
- Alpha-fetoprotein greater than the upper limit of normal (ULN) 
- Hepatitis C antibody positive 
- Hepatitis B surface antigen positive 
- Child's Pugh class A or B 
- Candidate for systemic therapy
Exclusion Criteria
- Fibrolamellar disease mixed histology 
- Metastatic brain or meningeal tumors

Trial Summary

Enrollment Goal
137
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Hôpital de la Timone - Marseille

MARSEILLE, France, 13005

Status
Completed
 
Locations

A.O.U. Pisana

Pisa, Italy, 56126

Status
Completed
 
Locations

Hadassah University Hospital Ein Kerem

Jerusalem, Israel, 91120

Status
Completed
 
Locations

Centre Eugène Marquis - Rennes Cedex

RENNES CEDEX, France, 35062

Status
Completed
 
Locations

Ospedale Borgo Trento

Verona, Italy, 37126

Status
Completed
 
Locations

Centre Oscar Lambret - Lille

LILLE CEDEX, France, 59020

Status
Completed
 
Locations

IRCCS Osp Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
Locations

Institut Jules Bordet/Jules Bordet Instituut

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

Centre René Gauducheau - Nantes

SAINT HERBLAIN, France, 44805

Status
Completed
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

AUSL Forlì - Emilia Romagna

Forlì, Italy, 47100

Status
Completed
 
Locations

Memorial Sloan-Kettering Cancer Center

New York, United States, 10021-6007

Status
Completed
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Completed
 
Locations

Kaplan Medical Center

Rehovot, Israel, 76100

Status
Completed
 
Locations

Metropolitan Hematology Oncology Medical Group

Los Angeles, United States, 90057

Status
Completed
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

UZ Brussel

BRUXELLES - BRUSSEL, Belgium, 1090

Status
Completed
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 52621

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Hôpital Tenon - Paris

PARIS, France, 75020

Status
Completed
 
Locations

Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel, 49100

Status
Completed
 
Locations

IRCCS Ist Clinico Humanitas

Rozzano, Italy, 20089

Status
Completed
 
Locations

Rambam Medical Center

Haifa, Israel, 31096

Status
Completed
 

Trial Design