We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

INSIGHT - Post Marketing Surveillance (INSIGHT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00792350
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Carcinoma, Hepatocellular Drug: Sorafenib (Nexavar, BAY43-9006)

Study Design

Study Type : Observational
Actual Enrollment : 791 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Study With Nexavar About Safety and Efficacy in Carcinoma Hepatocellular Therapy (HCC)
Study Start Date : April 2008
Primary Completion Date : October 2013
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Efficacy: status of tumor, patients performance status [ Time Frame: At each follow-up visit, every 2-4 months ]

Secondary Outcome Measures :
  1. Duration of treatment [ Time Frame: At each follow-up visit, every 2-4 months ]
  2. Time of survival [ Time Frame: At each follow-up visit, every 2-4 months ]
  3. Reports of adverse events [ Time Frame: At each follow-up visit, every 2-4 months ]

Biospecimen Retention:   None Retained
n.a

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT00792350


Locations
Austria
Many Locations, Austria
Germany
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00792350     History of Changes
Other Study ID Numbers: 14690
13419 ( Other Identifier: Company internal )
13420 ( Other Identifier: Company internal )
NX0801DE ( Other Identifier: Company internal )
NX0801AT ( Other Identifier: Company internal )
NX0801 ( Other Identifier: Company internal )
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by Bayer:
Carcinoma, Hepatocellular
Sorafenib

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action