INSIGHT - Post Marketing Surveillance (INSIGHT)

May 13, 2014 updated by: Bayer

International Study With Nexavar About Safety and Efficacy in Carcinoma Hepatocellular Therapy (HCC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

791

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Sorafenib (Nexavar, BAY43-9006)
Treatment of Hepatocellular Carcinoma with Nexavar (HCC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy: status of tumor, patients performance status
Time Frame: At each follow-up visit, every 2-4 months
At each follow-up visit, every 2-4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of treatment
Time Frame: At each follow-up visit, every 2-4 months
At each follow-up visit, every 2-4 months
Time of survival
Time Frame: At each follow-up visit, every 2-4 months
At each follow-up visit, every 2-4 months
Reports of adverse events
Time Frame: At each follow-up visit, every 2-4 months
At each follow-up visit, every 2-4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 14, 2008

First Posted (Estimate)

November 17, 2008

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14690
  • 13420 (Other Identifier: Company internal)
  • 13419 (Company internal)
  • NX0801DE (Other Identifier: Company internal)
  • NX0801AT (Other Identifier: Company internal)
  • NX0801 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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