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

Study Overview
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Brief Summary
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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.

Official Title
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Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Multi kinase inhibitor: 400 mg of Sorafenib, orally, twice a day, on a continuous basis as a single agent for the treatment of advanced RCC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters |  | From signing consent to 30 days after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limited radiological evaluations |  | At baseline, than every 8 weeks after start of sorafenib |