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

Carcinoma, Hepatocellular Clinical Trial

— GIDEON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812175
• Other study ID #: 13414
• Secondary ID: NX0802
• Status: Completed
• Phase: N/A
• First received: December 19, 2008
• Last updated: October 14, 2016
• Start date: January 2009
• Est. completion date: April 2012

Study information

• Verified date: October 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of HealthChina: National Natural Science FoundationChina: Food and Drug AdministrationColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCroatia: Agency for Medicinal Product and Medical DevicesCroatia: Ethics CommitteeCroatia: Ministry of Health and Social CareCroatia: Ministry of Science, Education and SportsCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlFrance: French Data Protection AuthorityGreece: Ministry of Health and WelfareGreece: National Organization of MedicinesHong Kong: Ethics CommitteeHungary: National Institute of PharmacyIndia: Ministry of HealthIndonesia: Departement Kesehatan (Department of Health)Indonesia: National Agency of Drug and Food ControlIsrael: Ethics CommissionItaly: Ethics CommitteeJapan: Pharmaceuticals and Medical Devices AgencySouth Korea: Korea Food and Drug Administration (KFDA)Mexico: Ethics CommitteeNorway: Data Protection AuthorityNorway: Directorate of HealthPhilippines: Department of HealthPortugal: Ethics Committee for Clinical ResearchPortugal: Health Ethic CommitteeRomania: Ethics CommitteeRussia: Ethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationSingapore: Clinical Trials & Epidemiology Research Unit (CTERU)Singapore: Domain Specific Review BoardsSingapore: Health Sciences AuthoritySlovenia: Agency for Medicinal Products - Ministry of HealthSlovenia: Ethics CommitteeSlovenia: Ministry of HealthSpain: Ministry of Health and ConsumptionSpain: Comité Ético de Investigación ClínicaSpain: Ethics CommitteeSpain: Ministry of HealthSpain: Spanish Agency of MedicinesSweden: Institutional Review BoardSweden: Medical Products AgencySweden: Regional Ethical Review BoardSweden: Swedish National Council on Medical EthicsSweden: Swedish Research CouncilSweden: The National Board of Health and WelfareUkraine: Central Ethical CommissionVenezuela: Ministry of HealthVietnam: Ministry of HealthVietnam: Central Ethical CommissionUnited States: Institutional Review BoardUnited States: Federal GovernmentUnited States: Food and Drug AdministrationFinland: Ethics CommitteeFinland: Ministry of Social Affairs and HealthFinland: Finnish Medicines AgencyKazakhstan: Ethical CommissionMalaysia: Ministry of HealthPakistan: Ministry of HealthSlovakia: State Institute for Drug ControlUruguay: Comite de EticaCanada: Ethics Review CommitteeThailand: Ethical CommitteeThailand: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3371
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Systemic oral therapy according to product information

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Uruguay,  Venezuela,  Vietnam,  Canada,  China,  Colombia,  Croatia,  Czech Republic,  Finland,  France,  Greece,  Hong Kong,  Hungary,  India,  Indonesia,  Israel,  Italy,  Japan,  Kazakhstan,  Korea, Republic of,  Libyan Arab Jamahiriya,  Malaysia,  Mexico,  Norway,  Pakistan,  Philippines,  Portugal,  Qatar,  Romania,  Russian Federation,  Singapore,  Slovakia,  Spain,  Sweden,  Syrian Arab Republic,  Thailand,  Ukraine,  United Arab Emirates, 

References & Publications (1)

Ye SL, Chen X, Yang J, Bie P, Zhang S, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Yip CS, Lu Z. Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		at each follow-up visit, every 2-4 months on average	Yes
Secondary	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		at every visit, roughly every 2-4 months	No
Secondary	The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables		at every visit, roughly every 2-4 months	No
Secondary	To evaluate the methods of patient evaluation, diagnosis and follow up		at every visit, roughly every 2-4 months	No
Secondary	To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome		at every visit, roughly every 2-4 months	No
Secondary	To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions		at every visit, roughly every 2-4 months	No
Secondary	Reports of adverse events		at every visit, roughly every 2-4 months	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.