check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

14690

ClinicalTrials.gov Identifier:

NCT00792350

EudraCT Number:

Not Available

EU CT Number:

Not Available
INSIGHT - Post Marketing Surveillance

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - In- and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar
  • - Exclusion criteria must be read in conjunction with the local product information

Trial summary

Enrollment Goal
791
Trial Dates
April 2008 - April 2014
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany
Completed
Many Locations, Austria

Primary Outcome

  • Efficacy: status of tumor, patients performance status
    date_rangeTime Frame:
    At each follow-up visit, every 2-4 months
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Duration of treatment
    date_rangeTime Frame:
    At each follow-up visit, every 2-4 months
    enhanced_encryption
    Safety Issue:
    no
  • Time of survival
    date_rangeTime Frame:
    At each follow-up visit, every 2-4 months
    enhanced_encryption
    Safety Issue:
    no
  • Reports of adverse events
    date_rangeTime Frame:
    At each follow-up visit, every 2-4 months
    enhanced_encryption
    Safety Issue:
    yes

Trial design

International Study with Nexavar about safety and efficacy in Carcinoma Hepatocellular therapy (HCC)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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