Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer

Withdrawn

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT01353794
• Lead Sponsor: Bayer

Brief Summary

The objective of this Non-Interventional study is to evaluate the effectiveness \& safety of Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions based on age of the patient (older (age \>70 years) and younger patients (age \<70 years). Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of cycles) and incidence of Hand foot Skin Reaction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Study Start: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-29
• Last Update Posted: 2015-01-30
• Primary Completion: 2017-09
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Sorafenib

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Sorafenib (Nexavar, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
Efficacy related variables are patient's performance status.	After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Efficacy related variable - Quality of Life (QOL) assessment by the patient	After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Efficacy related variables are status of tumor / metastases.	After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Efficacy related variables are efficacy assessment by the physician.	After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)

Secondary Outcome Measures

Name	Time	Method
General tolerability assessment by physician and reports of adverse events.	After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)