INSIGHT - Post Marketing Surveillance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00792350
First received: November 14, 2008
Last updated: May 13, 2014
Last verified: May 2014
  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)

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Efficacy: status of tumor, patients performance status [ Time Frame: At each follow-up visit, every 2-4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of treatment [ Time Frame: At each follow-up visit, every 2-4 months ] [ Designated as safety issue: No ]
  • Time of survival [ Time Frame: At each follow-up visit, every 2-4 months ] [ Designated as safety issue: No ]
  • Reports of adverse events [ Time Frame: At each follow-up visit, every 2-4 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

n.a


Enrollment: 791
Study Start Date: April 2008
Study Completion Date: April 2014
Primary Completion Date: October 2013 (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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00792350     History of Changes
Other Study ID Numbers: 14690, 13419, 13420, NX0801DE, NX0801AT, NX0801
Study First Received: November 14, 2008
Last Updated: May 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Ethikkommission

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
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014