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

Completed · Phase 3

Conditions studied: Carcinoma, Renal Cell

In brief

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.

Key facts

Study ID

NCT00111020

Run by

Bayer

People needed

2567

Starts

2005-06-01

Expected to finish

2008-10-01

Last updated by the study team

2014-08-06

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Cullman, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Anchorage, Alaska, United States
• Study site — Glendale, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Conway, Arkansas, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Pine Bluff, Arkansas, United States
• Study site — Springdale, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Beverly, California, United States
• Study site — Concord, California, United States
• Study site — Duarte, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Glendale, California, United States
• Study site — Highland, California, United States
• Study site — La Jolla, California, United States
• Study site — La Jolla, California, United States
• Study site — Loma Linda, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Bessemer, Alabama, United States

Full record on ClinicalTrials.gov

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