INSIGHT - Post Marketing Surveillance
This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00792350
First received: November 14, 2008
Last updated: April 16, 2013
Last verified: April 2013
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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
| Estimated Enrollment: | 800 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792350
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Locations
| Austria | |
| Recruiting | |
| Many Locations, Austria | |
| Germany | |
| Recruiting | |
| Many Locations, Germany | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer HealthCare AG |
| 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: | April 16, 2013 |
| 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 May 21, 2013