Status:
COMPLETED
A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Bayer
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
The following abbreviations were used in the Adverse Event section: * international normalized ratio (inr) * Common Terminology Criteria for Adverse Events (ctcae) * Not Otherwise Specified (nos) * G...
Eligibility Criteria
Inclusion
- 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 Hepatocellular Carcinoma (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 (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local therapy
- Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) of 0, 1, or 2
Exclusion
- 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 \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\] \& T1 \[Tumor invades subepithelial connective tissue\]). 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT00105443
Start Date
March 1 2005
End Date
November 1 2008
Last Update
October 31 2014
Active Locations (178)
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1
Phoenix, Arizona, United States, 85054-4502
2
Tucson, Arizona, United States, 85724
3
Los Angeles, California, United States, 90057
4
Los Angeles, California, United States, 90095-7077