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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):
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.

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

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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
Actual Primary Completion Date : October 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00792350    
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:
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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