A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma - Full Text View

Purpose

The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).

Condition	Intervention	Phase
Cancer Liver Cancer Hepatocellular Carcinoma (HCC)	Drug: Nexavar (Sorafenib, BAY43-9006) plus doxorubicin Drug: doxorubicin	Phase II

MedlinePlus related topics:

Cancer Liver Cancer

ChemIDplus related topics:

Doxorubicin Doxorubicin hydrochloride Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized Controlled Study of BAY 43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.

Further study details as provided by Bayer:

Primary Outcome Measures:

to evaluate the effect of doxorubicin plus sorafenib or doxorubicin plus placebo on TTP [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival (OS) [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
Progression Free Survival (PFS) [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
The overall response rate [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
Time to symptomatic progression (TTSP) [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
In an exploratory manner the relative TTP, TTSP, RR and overall survival between the 2 study populations [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
Overall response duration and time to objective response [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
Overall disease control rate [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
The safety, tolerability, and adverse event profiles of the two treatment regimens used in this trial [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
To evaluate possible and potentially predictive assays of clinical benefit through an exploratory assessment of the correlation between the defined baseline characteristics and key clinical endpoints. [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]
To compare doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo, and to correlate the PK data with doxorubicin-related adverse events (i.e., cardiotoxicity). [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]

Enrollment:	96
Study Start Date:	April 2005
Estimated Study Completion Date:	March 2008

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Nexavar (Sorafenib, BAY43-9006) plus doxorubicin multi kinase inhibitor plus chemotherapy
Arm 2: Active Comparator	Drug: doxorubicin chemotherapy plus placebo

Detailed Description:

Number of arms: 2

(Doxorubicin + BAY 43-9006 versus Doxorubicin + Placebo)

Eligibility

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

Criteria

Inclusion Criteria:

Patients who have a life expectancy of at least 12 weeks
Patients with advanced HCC (unresectable, and/or metastatic) which has been histologically or cytologically documented
Patients must have at least one tumor lesion that meets both of the following criteria: 1) can be accurately measured in at least one dimension according to RECIST; 2) has not been previously treated with local therapy
Patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. Local therapy must be completed at least 4 weeks prior to the baseline scan
Patients who have an ECOG performance status of 0, 1, or 2

Exclusion Criteria:

Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
History of cardiac disease
Serious myocardial dysfunction
Active, clinically serious infections
Known history of HIV infection
Known CNS tumors including metastatic brain disease
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108953

Locations


United States, California

	Palo Alto, California, United States, 94304-1207

	San Francisco, California, United States, 94115

	Beverly Hills, California, United States, 90211-1850

	Sylmar, California, United States, 91342

	San Francisco, California, United States, 94121

United States, Florida

	Miami, Florida, United States, 33136

United States, Minnesota

	Minneapolis, Minnesota, United States, 55455

United States, New Jersey

	Hackensack, New Jersey, United States, 07601-1991

United States, New York

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

	Rochester, New York, United States, 14642

United States, Tennessee

	Nashville, Tennessee, United States, 37203

United States, Washington

	Seattle, Washington, United States, 98101

Argentina
	Bayer Clinical Research Center
	ask Contact, Argentina

Canada
	Bayer Clinical Research Center
	ask Contact, Canada

Hong Kong
	Bayer Clinical Research Center
	ask Contact, Hong Kong

Russian Federation
	Bayer Clinical Research Center
	ask Contact, Russian Federation

United Kingdom
	Bayer Clinical Research Center
	ask Contact, United Kingdom

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

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Responsible Party:	( Bayer HealthCare AG, Therapeutic Area Head )
Study ID Numbers:	11546, EudraCT 2004-001770-40
First Received:	April 21, 2005
Last Updated:	December 31, 2007
ClinicalTrials.gov Identifier:	NCT00108953
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Liver Diseases

Digestive System Neoplasms

Carcinoma, Hepatocellular

Liver neoplasms

Doxorubicin

Carcinoma

Liver Neoplasms

Digestive System Diseases

Gastrointestinal Neoplasms

Adenocarcinoma

Sorafenib

Neoplasms, Glandular and Epithelial

Hepatocellular carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Antibiotics, Antineoplastic

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00108953