A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (SHARP)
Carcinoma, Hepatocellular

About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Liver Cancer, 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 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 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 [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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Sorafenib (Nexavar, BAY43-9006)
Placebo
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.