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Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib (GIDEON)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00812175
First received: December 19, 2008
Last updated: October 14, 2016
Last verified: October 2016
  Purpose
In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.

Condition Intervention
Carcinoma, Hepatocellular Drug: Sorafenib (Nexavar, BAY43-9006)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The safety of Nexavar in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions [ Time Frame: at each follow-up visit, every 2-4 months on average ]

Secondary Outcome Measures:
  • Efficacy [overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR), stable disease(SD) rate] by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria of Nexavar [ Time Frame: at every visit, roughly every 2-4 months ]
  • The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables [ Time Frame: at every visit, roughly every 2-4 months ]
  • To evaluate the methods of patient evaluation, diagnosis and follow up [ Time Frame: at every visit, roughly every 2-4 months ]
  • To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome [ Time Frame: at every visit, roughly every 2-4 months ]
  • To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions [ Time Frame: at every visit, roughly every 2-4 months ]
  • Reports of adverse events [ Time Frame: at every visit, roughly every 2-4 months ]

Enrollment: 3371
Study Start Date: January 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Systemic oral therapy according to product information

  Eligibility

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
Patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions and in a variety of patient subsets.
Criteria

Inclusion Criteria:

  • Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with Nexavar has been made. Radiographic diagnosis HCC NIS, needs typical findings of HCC by radiographic method i.e. on multi-dimensional, dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP), or MRI.
  • Patients must have signed an informed consent form
  • Patients must have a life expectancy of at least 8 weeks

Exclusion Criteria:

  • 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: NCT00812175

  Show 75 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00812175     History of Changes
Other Study ID Numbers: 13414
NX0802 ( Other Identifier: company internal )
Study First Received: December 19, 2008
Last Updated: October 14, 2016

Keywords provided by Bayer:
Hepatocellular Carcinoma
HCC
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
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 21, 2017