A Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma - Full Text View

A Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

This study is ongoing, but not recruiting participants.

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00105443

Purpose

The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

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

MedlinePlus related topics:

Cancer Liver Cancer

ChemIDplus related topics:

Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Ages eligible for study: 18 years and above, Genders eligible for study: both
Patients who have a life expectancy of at least 12 weeks
Patients with histologically or cytologically documented HCC
Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (2) Not previously treated with local therapy
Patients who have an ECOG PS 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, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
Renal failure requiring hemo- or peritoneal dialysis
History of cardiac disease
Active clinically serious infections
Known history of human immunodeficiency virus (HIV) infection
Known central nervous system 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: NCT00105443

Show 45 Study Locations

Sponsors and Collaborators

Bayer

More Information

Study ID Numbers:	100554
First Received:	March 14, 2005
Last Updated:	September 27, 2006
ClinicalTrials.gov Identifier:	NCT00105443
Health Authority:	United States: Food and Drug Administration

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 July 18, 2008