Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
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|ClinicalTrials.gov Identifier: NCT00494299|
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : January 20, 2011
Last Update Posted : December 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: Sorafenib (Nexavar, BAY43-9006) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||458 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||November 2010|
Experimental: Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
Drug: Sorafenib (Nexavar, BAY43-9006)
Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib
Placebo Comparator: Placebo
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
Placebo: matching placebo
- Time to Progression (TTP) [ Time Frame: From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months. ]Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
- Overall Survival (OS) [ Time Frame: From randomization of the first subject until 39 months later. ]Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494299
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|Study Director:||Bayer Study Director||Bayer|