INSIGHT - Post Marketing Surveillance

Completed

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

• Registration Number: NCT00792350
• Lead Sponsor: Bayer

Brief Summary

In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the duration of Sorafenib treatment.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-17
• Primary Completion: 2013-10
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 791

Inclusion Criteria

• In- and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar

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Exclusion Criteria

• Exclusion criteria must be read in conjunction with the local product information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Sorafenib (Nexavar, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
Efficacy: status of tumor, patients performance status	At each follow-up visit, every 2-4 months

Secondary Outcome Measures

Name	Time	Method
Duration of treatment	At each follow-up visit, every 2-4 months
Time of survival	At each follow-up visit, every 2-4 months
Reports of adverse events	At each follow-up visit, every 2-4 months