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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00812175
First received: December 19, 2008
Last updated: July 11, 2012
Last verified: July 2012
  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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the methods of patient evaluation, diagnosis and follow up [ Time Frame: at every visit, roughly every 2-4 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Reports of adverse events [ Time Frame: at every visit, roughly every 2-4 months ] [ Designated as safety issue: Yes ]

Enrollment: 3721
Study Start Date: January 2009
Study Completion Date: April 2012
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
Genders Eligible for Study:   Both
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

  Hide Study Locations
Locations
United States, Alabama
Many Locations, Alabama, United States
United States, Arizona
Many Locations, Arizona, United States
United States, Arkansas
Many Locations, Arkansas, United States
United States, California
Many Locations, California, United States
United States, Colorado
Many Locations, Colorado, United States
United States, Connecticut
Many Locations, Connecticut, United States
United States, Florida
Many Locations, Florida, United States
United States, Georgia
Many Locations, Georgia, United States
United States, Hawaii
Many Locations, Hawaii, United States
United States, Illinois
Many Locations, Illinois, United States
United States, Indiana
Many Locations, Indiana, United States
United States, Iowa
Many Locations, Iowa, United States
United States, Kansas
Many Locations, Kansas, United States
United States, Kentucky
Many Locations, Kentucky, United States
United States, Louisiana
Many Locations, Louisiana, United States
United States, Maryland
Many Locations, Maryland, United States
United States, Massachusetts
Many Locations, Massachusetts, United States
United States, Michigan
Many Locations, Michigan, United States
United States, Minnesota
Many Locations, Minnesota, United States
United States, Missouri
Many Locations, Missouri, United States
United States, Nebraska
Many Locations, Nebraska, United States
United States, Nevada
Many Locations, Nevada, United States
United States, New Hampshire
Many Locations, New Hampshire, United States
United States, New Jersey
Many Locations, New Jersey, United States
United States, New York
Many Locations, New York, United States
United States, North Carolina
Many Locations, North Carolina, United States
United States, Ohio
Many Locations, Ohio, United States
United States, Oklahoma
Many Locations, Oklahoma, United States
United States, Oregon
Many Locations, Oregon, United States
United States, Pennsylvania
Many Locations, Pennsylvania, United States
United States, South Carolina
Many Locations, South Carolina, United States
United States, Tennessee
Many Locations, Tennessee, United States
United States, Texas
Many Locations, Texas, United States
United States, Utah
Many Locations, Utah, United States
United States, Virginia
Many Locations, Virginia, United States
United States, Washington
Many Locations, Washington, United States
United States, Wisconsin
Many Locations, Wisconsin, United States
Canada
Many Locations, Canada
China
Many Locations, China
Colombia
Many Locations, Colombia
Croatia
Many Locations, Croatia
Czech Republic
Many Locations, Czech Republic
Finland
Many Locations, Finland
France
Many Locations, France
Greece
Many Locations, Greece
Hong Kong
Many Locations, Hong Kong
Hungary
Many Locations, Hungary
India
Many Locations, India
Indonesia
Many Locations, Indonesia
Israel
Many Locations, Israel
Italy
Many Locations, Italy
Japan
Many Locations, Japan
Kazakhstan
Many Locations, Kazakhstan
Korea, Republic of
Many Locations, Korea, Republic of
Libyan Arab Jamahiriya
Many Locations, Libyan Arab Jamahiriya
Malaysia
Many Locations, Malaysia
Mexico
Many Locations, Mexico
Norway
Many Locations, Norway
Pakistan
Many Locations, Pakistan
Philippines
Many Locations, Philippines
Portugal
Many Locations, Portugal
Qatar
Many Locations, Qatar
Romania
Many Locations, Romania
Russian Federation
Many Locations, Russian Federation
Singapore
Many Locations, Singapore
Slovakia
Many Locations, Slovakia
Slovenia
Many Locations, Slovenia
Spain
Many Locations, Spain
Sweden
Many Locations, Sweden
Syrian Arab Republic
Many Locations, Syrian Arab Republic
Thailand
Many Locations, Thailand
Ukraine
Many Locations, Ukraine
United Arab Emirates
Many Locations, United Arab Emirates
Uruguay
Many Locations, Uruguay
Venezuela
Many Locations, Venezuela
Vietnam
Many Locations, Vietnam
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00812175     History of Changes
Other Study ID Numbers: 13414, NX0802
Study First Received: December 19, 2008
Last Updated: July 11, 2012
Health Authority: China: Ethics Committee
China: Ministry of Health
China: National Natural Science Foundation
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Agency for Medicinal Product and Medical Devices
Croatia: Ethics Committee
Croatia: Ministry of Health and Social Care
Croatia: Ministry of Science, Education and Sports
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
France: French Data Protection Authority
Greece: Ministry of Health and Welfare
Greece: National Organization of Medicines
Hong Kong: Ethics Committee
Hungary: National Institute of Pharmacy
India: Ministry of Health
Indonesia: Departement Kesehatan (Department of Health)
Indonesia: National Agency of Drug and Food Control
Israel: Ethics Commission
Italy: Ethics Committee
Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)
Mexico: Ethics Committee
Norway: Data Protection Authority
Norway: Directorate of Health
Philippines: Department of Health
Portugal: Ethics Committee for Clinical Research
Portugal: Health Ethic Committee
Romania: Ethics Committee
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee
Slovenia: Ministry of Health
Spain: Ministry of Health and Consumption
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Institutional Review Board
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Sweden: Swedish National Council on Medical Ethics
Sweden: Swedish Research Council
Sweden: The National Board of Health and Welfare
Ukraine: Central Ethical Commission
Venezuela: Ministry of Health
Vietnam: Ministry of Health
Vietnam: Central Ethical Commission
United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration
Finland: Ethics Committee
Finland: Ministry of Social Affairs and Health
Finland: Finnish Medicines Agency
Kazakhstan: Ethical Commission
Malaysia: Ministry of Health
Pakistan: Ministry of Health
Slovakia: State Institute for Drug Control
Uruguay: Comite de Etica
Canada: Ethics Review Committee
Thailand: Ethical Committee
Thailand: Food and Drug Administration

Keywords provided by Bayer:
Hepatocellular Carcinoma
HCC
Sorafenib

Additional relevant MeSH terms:
Sorafenib
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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014