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

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 Liver 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

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

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

Responsible Party:	Bayer HealtCare Pharmaceuticals ( Therapeutic Area Head )
Study ID Numbers:	10874
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 November 20, 2008

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