Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar

Carcinoma, Renal Cell Clinical Trial

Official title:

Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895674
• Other study ID #: 14686
• Secondary ID: NX0601PREDICT126
• Status: Completed
• Phase: N/A
• First received: May 6, 2009
• Last updated: September 29, 2010
• Start date: July 2006
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustria: EthikkommissionChina: Ethics CommitteeColombia: Ethics CommitteeCzech Republic: State Institute for Drug ControlFrance: French Data Protection AuthorityGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesGreece: Ministry of Health and WelfareGreece: National Organization of MedicinesIndonesia: National Agency of Drug and Food ControlSouth Korea: Korea Food and Drug Administration (KFDA)Mexico: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Philippines: Bureau of Food and DrugsPhilippines: Department of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Ethics CommitteeSlovakia: State Institute for Drug ControlSlovenia: Ethics CommitteeSweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2840
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Sorafenib

Exclusion Criteria:

• Exclusion criteria must be read in conjunction with the local product information

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Carcinoma, Renal Cell (Advanced)

Intervention

Drug:
• Nexavar (Sorafenib, BAY43-9006)
Patients with a diagnosis of advanced RCC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Argentina,  Austria,  China,  Colombia,  Czech Republic,  France,  Germany,  Greece,  Indonesia,  Korea, Republic of,  Mexico,  Netherlands,  Philippines,  Poland,  Russian Federation,  Slovakia,  Slovenia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor status		After about 3, 6, 9 and 12 months	No
Secondary	Treatment duration		At end of study after about 12 months	No
Secondary	Safety of sorafenib treatment		At every documented visit for about 12 months	Yes
Secondary	Progression-free survival		Calculation at end of study after about 12 months	No
Secondary	Status of Metastases		After about 3, 6, 9 and 12 months	No
Secondary	Performance status (ECOG)		After about 3, 6, 9 and 12 months	No

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