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

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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.