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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Completed 18 and over Pharmaceutical / Industry 100554
EudraCT No: 2004-001773-26, SHARP, NCT00105443

Trial Description

Summary

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Bayer Corporation

Bayer Study Director

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00105443
Information obtained from ClinicalTrials.gov on October 25, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.