Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

Phase 3

Completed

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: Placebo; Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT00494299
• Lead Sponsor: Bayer

Brief Summary

Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-06-28
• Study First Submitted QC: 2007-06-28
• Study First Posted: 2007-06-29
• Primary Completion: 2009-07
• Study Completion: 2010-11
• Results First Submitted: 2010-12-21
• Results First Submitted QC: 2010-12-21
• Results First Posted: 2011-01-20
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

• Male or female
• Aged of 18 and over
• Advanced hepatocellular carcinoma

Exclusion Criteria

• History of prior systemic chemotherapy
• Failure in vital organ

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
Sorafenib (Nexavar, BAY43-9006)	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.

Primary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	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.