Nexavar as First Targeted Therapy in Patients With Advanced Renal Cell Carcinoma

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: Sorafenib (Nexavar, BAY 43-9006)

• Registration Number: NCT01508364
• Lead Sponsor: Bayer

Brief Summary

This is an observational study which will investigate the use of Nexavar as first targeted therapy in patients with advanced renal cell carcinoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Study Start: 2012-07
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with a diagnosis of advanced Renal cell carcinoma (RCC) for whom the decision has been taken by the investigator to prescribe Nexavar.
• Patients who failed cytokine therapy or who are not suitable for cytokines for whom Nexavar is the first targeted drug treatment.

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Exclusion Criteria

• Prior targeted therapy for RCC
• Contraindications of Nexavar described in the Summary of Product Characteristics (SPC).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Sorafenib (Nexavar, BAY 43-9006)	-

Primary Outcome Measures

Name	Time	Method
Duration of Nexavar treatment	up to 3 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	1 - 1.5 years after LPLV
Health related quality of life (HRQoL)	up to 3 years
Tumor status, of patients will be evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", "Clinical Progression", "Radiological Progression".	up to 3 years
Incidence of Treatment-emergent Adverse Events (TEAE)	up to 3 years
Progression-free survival (PFS)	up to 3 years