Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy (STELLA)
This study has been completed.
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01539681
First received: December 13, 2011
Last updated: February 16, 2016
Last verified: February 2016
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Purpose
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 | Intervention |
|---|---|
|
Hepatocellular Carcinoma |
Drug: Sorafenib (Nexavar, BAY43-9006) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 234 |
| Study Start Date: | February 2012 |
| Study Completion Date: | February 2015 |
| Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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: NCT01539681
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539681
Locations
| Italy | |
| Many Locations, Italy | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT01539681 History of Changes |
| Other Study ID Numbers: | 16028 NX1110IT |
| Study First Received: | December 13, 2011 |
| Last Updated: | February 16, 2016 |
| Health Authority: | Italy: Italian Medicines Agency (AIFA) |
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 |
ClinicalTrials.gov processed this record on September 28, 2016