INSIGHT - Post Marketing Surveillance - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00792350

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.

Condition	Intervention
Carcinoma, Hepatocellular	Drug: Sorafenib (Nexavar, BAY43-9006)

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	International Study With Nexavar About Safety and Efficacy in Carcinoma Hepatocellular Therapy ( HCC)

Further study details as provided by Bayer:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	800
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: Sorafenib (Nexavar, BAY43-9006) Treatment of Hepatocellular Carcinoma with Nexavar (HCC)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792350

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Germany
	Recruiting
Many locations, Germany

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	13419, 13420, NX0801DE, NX0801AT
Study First Received:	November 14, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00792350
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Austria: Ethikkommission

Keywords provided by Bayer:

Carcinoma, Hepatocellular
Sorafenib

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms

Gastrointestinal Neoplasms
Adenocarcinoma
Sorafenib
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009