A Phase III randomized, placebo-controlled study of sorafenib in patients with advanced hepatocellular carcinoma
- Conditions
- Advanced hepatocellular carcinoma.Cancer - Liver
- Registration Number
- ACTRN12605000644662
- Lead Sponsor
- Bayer Australia Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 602
Patients who have a life expectancy of at least 12 weeks.Patients with advanced HCC. Patients with histologically or cytologically documented HCC. Patients must have at least one tumor lesion that can be accurately measured in at least one dimension and has not been previously treated with local therapy.
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.History of organ allograft.Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results.Known or suspected allergy to the investigational agent or any agent given in association with this trial.Patients unable to swallow oral medications.Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the studyPregnant or breast-feeding patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method