Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

Phase 3

Completed

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

• Registration Number: NCT00111020
• Lead Sponsor: Bayer

Brief Summary

This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-05-16
• Study First Submitted QC: 2005-05-16
• Study First Posted: 2005-05-17
• Study Start: 2005-06
• Primary Completion: 2007-06
• Study Completion: 2008-10
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2567

Inclusion Criteria

• Patients with advanced (unresectable, recurrent or metastatic) RCC
• Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy
• Patients with an ECOG performance status of 0-2
• Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib
• Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice

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Exclusion Criteria

• Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial
• Patients who have participated in any other sorafenib trial
• Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry
• Life expectancy of less than two months
• Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0
• Patients with active coronary artery disease or ischemia
• Patients with Child-Pugh class C hepatic impairment
• Patients with severe renal impairment or who require dialysis
• Patients with active uncontrolled hypertension
• Patients with recent or active bleeding diathesis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety parameters	From signing consent to 30 days after last dose of study drug

Secondary Outcome Measures

Name	Time	Method
Limited radiological evaluations	At baseline, than every 8 weeks after start of sorafenib