Status:
COMPLETED
Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Lead Sponsor:
Bayer
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
15+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
2567 Patients enrolled
Trial Details
Trial ID
NCT00111020
Start Date
June 1 2005
End Date
October 1 2008
Last Update
August 6 2014
Active Locations (320)
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1
Bessemer, Alabama, United States, 35023
2
Cullman, Alabama, United States, 35058
3
Mobile, Alabama, United States, 36608
4
Anchorage, Alaska, United States, 99508