ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
A Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

This study is ongoing, but not recruiting participants.
Information provided by Bayer

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  A Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Official Title 
Brief 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.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cancer
Liver Cancer
Hepatocellular Carcinoma (HCC)
Intervention  Drug: Nexavar (Sorafenib, BAY43-9006)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date 
Completion Date
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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers
Contacts ††
Location Countries  United States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   France,   Germany,   Greece,   Israel,   Italy,   Mexico,   New Zealand,   Poland,   Romania,   Russian Federation,   Spain,   Switzerland,   United Kingdom
Administrative Information Fields
NCT ID  NCT00105443
Organization ID 100554
Secondary IDs ††
Study Sponsor  Bayer
Collaborators ††
Investigators 
Information Provided By Bayer
Verification Date September 2006
First Received Date  March 14, 2005
Last Updated Date September 27, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers