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Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy (STELLA)

This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01539681
First received: December 13, 2011
Last updated: May 9, 2013
Last verified: May 2013
History of Changes

December 13, 2011
May 9, 2013
February 2012
December 2014   (final data collection date for primary outcome measure)
Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma. [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01539681 on ClinicalTrials.gov Archive Site
  • Adverse event collection of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma. [ Time Frame: every 4 months on average within approx. 2 years ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Time to Progression [ Time Frame: every 4 months on average within approx. 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy
Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly

Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Hepatocellular Carcinoma Patients treated in Italy
Hepatocellular Carcinoma
Drug: Sorafenib (Nexavar, BAY43-9006)
Subjects should be treated with sorafenib in compliance with the recommendations written in the local product information.However, the decision on the duration and dose of treatment is at the discretion of the prescribing physician.
Group 1
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made
  • Patients must have signed the informed consent form
  • Patients must have a life expectancy of at least 8 weeks Inclusion criteria must follow the approved local product information.

Exclusion Criteria:

  • Prior treatment with sorafenib
  • Concomitant participation in other clinical studies Exclusion criteria must follow the approved local product information.
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Italy
 
NCT01539681
16028, NX1113IT
No
Medical Director, Bayer HealthCare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP