A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) 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: Sorafenib (Nexavar, BAY43-9006)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) 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:

Percentage of Participants for Each Type of Response [ Time Frame: Until 30 days after termination of active therapy ] [ Designated as safety issue: No ]
Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.

Secondary Outcome Measures:

Duration of Response [ Time Frame: up to 3 years later ] [ Designated as safety issue: No ]
Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.
Time to Response [ Time Frame: up to 3 years later ] [ Designated as safety issue: No ]
Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).
Time to Progression [ Time Frame: up to 3 years later ] [ Designated as safety issue: No ]
Time from the first date of receiving study drug until the first documented PD.
Duration of Stable Disease [ Time Frame: up to 3 years later ] [ Designated as safety issue: No ]
Time from the first day of receiving study drug until there was a documented PD or response.
Time to Minor Response [ Time Frame: up to 3 years later ] [ Designated as safety issue: No ]
Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.
Duration of Minor Response [ Time Frame: Time from MR to PD ] [ Designated as safety issue: No ]
Time from the date that MR was first documented to the date that PD was first documented.
Overall Survival [ Time Frame: Start of treatment to death ] [ Designated as safety issue: No ]
Time from the first date of receiving study medication to death.

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
Experimental: Sorafenib 400 mg b.i.d. Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)	Drug: Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)

Detailed Description:

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

Pharmacokinetics (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

Bruxelles - Brussel, Belgium, 1070

Bruxelles - Brussel, Belgium, 1090

Gent, Belgium, 9000

Leuven, Belgium, 3000
France

Lille Cedex, France, 59020

Marseille, France, 13005

Paris, France, 75020

Rennes Cedex, France, 35062

Saint Herblain, France, 44805
Israel

Haifa, Israel, 31096

Jerusalem, Israel, 91120

Petach Tikva, Israel, 49100

Rehovot, Israel, 76100

Tel Aviv, Israel, 64239

Tel Hashomer, Israel, 52621
Italy

Rozzano, Milano, Italy, 20089

Forlì, Italy, 47100

Milano, Italy, 20122

Pisa, Italy, 56126

Verona, Italy, 37126

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

Publications:

Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24(26):4293-300. Epub 2006 Aug 14.

Responsible Party:	Therapeutic Area Head, Bayer HealtCare Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00044512 History of Changes
Obsolete Identifiers:	NCT00048919, NCT00058383
Other Study ID Numbers:	10874
Study First Received:	August 30, 2002
Results First Received:	February 20, 2009
Last Updated:	January 27, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Cancer
Liver Cancer
Hepatocellular carcinoma (HCC)

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012