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

Sponsored by:	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

MedlinePlus related topics: Cancer

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

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

Further study details as provided by Bayer:

Primary Outcome Measures:

1. To evaluate the anti-cancer activity (e.g. proportion of patients with confirmed complete responses and partial responses as per the WHO criteria) in patients with advanced inoperable biopsy-proven hepatocellular carcinoma [ Time Frame: Tumor response measurements will be made at baseline and every 8 weeks, within the last 10 days of each dual cycle during the treatment period, according to WHO criteria. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1. To determine duration of response, time to response, time to progression, duration of stable disease and survival. [ Time Frame: Tumor response measurements will be made at baseline and every 8 weeks, within the last 10 days of each dual cycle during the treatment period, according to WHO criteria. ] [ Designated as safety issue: No ]
2. To evaluate proportion of patients with stable disease. [ Time Frame: Tumor response measurements will be made at baseline and every 8 weeks, within the last 10 days of each dual cycle during the treatment period, according to WHO criteria. ] [ Designated as safety issue: No ]
3. To determine the toxicities of this treatment regimen, [ Time Frame: Tumor response measurements will be made at baseline and every 8 weeks, within the last 10 days of each dual cycle during the treatment period, according to WHO criteria. ] [ Designated as safety issue: No ]
4. Pharmacokinetic profiles of sorafenib will be determined in approximately 20-23 patients enrolled in selected sites, to receive all requested plasma samples from 16 patients with valid pharmacokinetic data. [ Time Frame: Tumor response measurements will be made at baseline and every 8 weeks, within the last 10 days of each dual cycle during the treatment period, according to WHO criteria. ] [ Designated as safety issue: No ]
5. To evaluate pERK concentration in the original tumor biopsy, when possible, and correlate it with measures of clinical benefit (e.g. response, time to progression and survival). [ Time Frame: Tumor response measurements will be made at baseline and every 8 weeks, within the last 10 days of each dual cycle during the treatment period, according to WHO criteria. ] [ Designated as safety issue: No ]

Enrollment:	147
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
Arm 1: Experimental	Drug: Nexavar (Sorafenib, BAY43-9006) Multi Kinase Inhibitor (BAY 43-9006 400 mg bid daily)

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 at least 2 cm by CT scan or 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

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Responsible Party:	Bayer HealtCare Pharmaceuticals ( Therapeutic Area Head )
Study ID Numbers:	10874
Study First Received:	August 30, 2002
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00044512
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Cancer
Liver Cancer
Hepatocellular carcinoma (HCC)

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms

Gastrointestinal Neoplasms
Adenocarcinoma
Sorafenib
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009