A Study to Estimate Safety and Efficacy of Bay 43-9006 in the Treatment of Hepatocellular Carcinoma - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00044512

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.

Condition	Intervention	Phase
Carcinoma, Hepatocellular	Drug: Nexavar (Sorafenib, BAY43-9006)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Multicenter Uncontrolled Trial of BAY 43-9006 in Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Objective Response Rate [ Time Frame: Until 30 days after termination of active therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of Response [ Time Frame: Time from first dose of study drug until disease progression ] [ Designated as safety issue: No ]
Time to Response [ Time Frame: Until objective response occurs ] [ Designated as safety issue: No ]
Time to Progression [ Time Frame: Until progression occurs ] [ Designated as safety issue: No ]
Duration of Stable Disease [ Time Frame: Until documented PD or response. ] [ Designated as safety issue: No ]
Time to Minor Response [ Time Frame: Until MR was first documented ] [ Designated as safety issue: No ]
Duration of Minor Response [ Time Frame: Time from MR to PD ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: Start of treatment to death ] [ Designated as safety issue: No ]

Enrollment:	137
Study Start Date:	August 2002
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sorafenib 400 mg b.i.d.: Experimental Sorafenib (BAY 43-9006) 400 mg administered b.i.d.	Drug: Nexavar (Sorafenib, BAY43-9006) BAY 43-9006 400 mg bid daily

Detailed Description:

In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:

PK profile of Sorafenib
Plasma and tissue tumor biomarkers

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044512

Locations

United States, California

Los Angeles, California, United States, 90057
United States, New York

New York, New York, United States, 10021-6007
Belgium

BRUXELLES - BRUSSEL, Belgium, 1000

GENT, Belgium, 9000

BRUXELLES - BRUSSEL, Belgium, 1070

BRUXELLES - BRUSSEL, Belgium, 1090

LEUVEN, Belgium, 3000
France

SAINT HERBLAIN, France, 44805

MARSEILLE, France, 13005

RENNES CEDEX, France, 35062

PARIS, France, 75020

LILLE CEDEX, France, 59020
Israel

Tel Aviv, Israel, 64239

Rehovot, Israel, 76100

Jerusalem, Israel, 91120

Tel Hashomer, Israel, 52621

Petach Tikva, Israel, 49100

Haifa, Israel, 31096
Italy

Forlì, Italy, 47100

Pisa, Italy, 56126

Verona, Italy, 37126

Milano, Italy, 20122
Italy, Milano

Rozzano, Milano, Italy, 20089

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer HealtCare Pharmaceuticals ( Therapeutic Area Head )
Study ID Numbers:	10874
Study First Received:	August 30, 2002
Results First Received:	February 20, 2009
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00044512 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Cancer
Liver Cancer
Hepatocellular carcinoma (HCC)

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Hepatocellular
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 05, 2009