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Sorafenib in Refractory Metastatic RCC
NCT00866320Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2006
- Primary completion
- Dec 2009
- Countries
- 1
- Sponsor
- Case Comprehensive Cancer Center
- Modality
- Small Molecules
- Drugs
- sorafenib
- Conditions
- clear cell renal cell carcinoma (ccRCC)
01
Overview
Phase 2, open-label, single-arm trial of sorafenib in clear cell renal cell carcinoma (ccRCC), sponsored by Case Comprehensive Cancer Center. Primary endpoint: Tumor Burden Reduction Rate at 8 weeks. Started Feb 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Sorafenib
Oral sorafenib tosylate twice daily.
03
Who it enrols
Patients with metastatic clear cell RCC who have progressed on sunitinib or bevacizumab, with good performance status and organ function.
04
Endpoints
Primary
Tumor Burden Reduction Rate
Secondary
Safety of sorafenib tosylate
Duration of Overall Response
Time to Progression
Overall Survival
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