At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 226 enrolled
Drug / intervention
Sorafenib (Nexavar, BAY43-9006) +1 moredrug
Likely dose
Sorafenib (Nexavar, BAY43-9006) 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blinded, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
In Brief
A Phase 3 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) and Placebo for Carcinoma, Hepatocellular. Completed, enrolled 226 participants across 23 sites in 3 countries.
Detailed 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 or shrinks liver tumors and / or their metastases * Determine the pharmacokinetics (PK) in patients with liver cancer
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesChina, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
Primary CompletionMar 2007
First PostedJun 2007
Study CompletionJul 2009
TodayJul 2026
First PostedJun 27, 2007
Enrollment StartOct 1, 2005
Primary CompletionMar 1, 2007
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.0 years ago
Interventions
Sorafenib (Nexavar, BAY43-9006)drug
multikinase inhibitor; Sorafenib 400 mg (orally) twice daily
Placebodrug
Matching placebo (orally) twice daily