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

Bayer

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00111020

11868

Details and patient eligibility

About

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.

Enrollment: 2,567 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,567 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)