Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT03289533 - A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100) Phase 1
Terminated NCT01141478 - Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria N/A
Recruiting NCT05580835 - PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma N/A
Active, not recruiting NCT05389527 - Pembrolizumab and Lenvatinib for Resectable Hepatocellular Carcinoma Phase 2
Not yet recruiting NCT04560751 - TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma (Prolong)
Withdrawn NCT02939807 - A Phase II Study of ABC294640 as Monotherapy in Patients With Advanced Hepatocellular Carcinoma Phase 2
Completed NCT01915602 - Refametinib in Combination With Sorafenib in RAS Mutant Hepatocellular Carcinoma (HCC) Phase 2
Completed NCT04970212 - Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures
Recruiting NCT02403544 - Phase I Study of Image-Guided Radiation Concurrent With Double-Agent Chemotherapy for Hepatocellular Carcinoma Phase 1
Completed NCT01897038 - A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma Phase 1
Terminated NCT01337492 - Pilot Study Sorafenib as Bridge to Orthotopic Liver Transplantation (OLT) Phase 0
Completed NCT01003015 - Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma Phase 2
Completed NCT01012011 - Regulatory Post Marketing Surveillance Study on Nexavar® N/A
Terminated NCT01020812 - Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma Phase 1/Phase 2
Completed NCT00559455 - Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma Phase 2
Recruiting NCT00384800 - A Phase II Study of Tegafur/Uracil (UFUR®)Plus Thalidomide for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma (HCC) Phase 2
Terminated NCT00582400 - A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver Phase 2
Completed NCT00056992 - Testing of ADI-PEG in Hepatocellular Carcinoma Phase 2
Completed NCT02859324 - A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC) Phase 1/Phase 2
Terminated NCT02439008 - Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response N/A