A Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ®

This study is currently recruiting participants.

Verified by Bayer, April 2009

First Received: October 9, 2008 Last Updated: April 3, 2009 History of Changes

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00771147

Purpose

Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.

Condition	Intervention	Phase
Advanced Renal Cell Carcinoma ( RCC)	Drug: Nexavar (Sorafenib, BAY43-9006)	Phase IV

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Prospective Open-Label Non-Interventional, Non-Controlled Multi Observational and Pharmaco-Economic Phase IV Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® as Well as Effectiveness, Safety and Direct Medical Costs of Nexavar® Treatment Under Daily-Life Treatment Conditions

Further study details as provided by Bayer:

Primary Outcome Measures:

Proportion of patients who are progression-free at one year according to the RECIST criteria. The proportion of patients who are progression-free at 1, 3, 6 and 9 months will also be calculated [ Time Frame: At 1, 3, 6 and 9 months and after one year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

n.a.

Estimated Enrollment:	125
Study Start Date:	June 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Arm 1	Drug: Nexavar (Sorafenib, BAY43-9006) Patients with diagnosis of advanced renal cell cancer and decision taken by the investigator to prescribe Nexavar®.

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 diagnosis of advanced Renal Cell Carcimona

Criteria

Inclusion Criteria:

Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Nexavar®. The patients should have sufficient knowledge of French or Dutch to be able to participate in the Study

Exclusion Criteria:

Exclusion criteria must be read in conjunction with the Belgian product information

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771147

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Belgium
	Recruiting
GENT, Belgium, 9000
	Recruiting
ANTWERPEN, Belgium, 2020
	Not yet recruiting
BRUXELLES - BRUSSEL, Belgium, 1200
	Recruiting
BRASSCHAAT, Belgium, 2930
	Recruiting
TURNHOUT, Belgium, 2300
	Recruiting
BRUGGE, Belgium, 8000
	Recruiting
BONHEIDEN, Belgium, 2820
	Not yet recruiting
MERKSEM, Belgium, 2170
	Recruiting
AALST, Belgium, 9300
	Recruiting
ROESELARE, Belgium, 8800
	Recruiting
LA LOUVIERE, Belgium, 7100
	Recruiting
LIEGE, Belgium, 4000
	Not yet recruiting
ANTWERPEN, Belgium, 2060
	Not yet recruiting
CHIMAY, Belgium, 6460
	Recruiting
OOSTENDE, Belgium, 8400
	Not yet recruiting
OOSTENDE, Belgium, 8400
	Not yet recruiting
BRUXELLES - BRUSSEL, Belgium, 1070
	Not yet recruiting
YVOIR, Belgium, 5530
	Recruiting
ARLON, Belgium, 6700
	Recruiting
DENDERMONDE, Belgium, 9200
	Not yet recruiting
BRAINE-L'ALLEUD, Belgium, 1420
	Not yet recruiting
HUY, Belgium, 4500
	Not yet recruiting
BRUXELLES - BRUSSEL, Belgium, 1000
	Recruiting
BRUXELLES - BRUSSEL, Belgium, 1070
	Not yet recruiting
EDEGEM, Belgium, 2650
	Not yet recruiting
BOUGE, Belgium, 5004
	Recruiting
IEPER, Belgium, 8900
	Not yet recruiting
GILLY, Belgium, 6060
	Not yet recruiting
CHARLEROI, Belgium, 6000
	Terminated
GEEL, Belgium, 2440
	Not yet recruiting
KORTRIJK, Belgium, 8500

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

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	13102
Study First Received:	October 9, 2008
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00771147 History of Changes
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Urogenital Neoplasms
Urologic Neoplasms
Protein Kinase Inhibitors
Carcinoma
Renal Cancer

Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009