Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00812175

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:

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

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 ]

Estimated Enrollment:	3000
Study Start Date:	January 2009
Estimated Study Completion Date:	April 2012
Estimated 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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812175

Show 76 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

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

No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lencioni R, Marrero J, Venook A, Ye SL, Kudo M. Design and rationale for the non-interventional Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with Sorafenib (GIDEON) study. Int J Clin Pract. 2010 Jul;64(8):1034-41.

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:	January 23, 2012
Health Authority:	China: Ethics Committee; China: Ministry of Health; China: National Natural Science Foundation; China: State 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 Inspectorate; Norway: Directorate for Health and Social Affairs; 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:

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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012