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Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy (STELLA)

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ClinicalTrials.gov Identifier: NCT01539681
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

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

Study Design
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Study Type : Observational
Actual Enrollment : 234 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly
Study Start Date : February 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1 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.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma. [ Time Frame: at 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. Overall survival [ Time Frame: at 1 year ]
  3. Time to Progression [ Time Frame: every 4 months on average within approx. 2 years ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hepatocellular Carcinoma Patients treated in Italy
Criteria

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.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More 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): NCT01539681


Locations
Italy
Many Locations, Italy
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here and search for websynopsis results  This link exits the ClinicalTrials.gov site

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01539681     History of Changes
Other Study ID Numbers: 16028
NX1110IT ( Other Identifier: company internal )
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016

Keywords provided by Bayer:
Hepatocellular Carcinoma
Cancer, Liver
Sorafenib
Nexavar

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
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs