Clinical Trial Design
AFINITOR: PFS proven in a diverse patient population1
- Clear-cell aRCC
- Progressive disease on or within 6 months of stopping VEGFR-TKI (sunitinib and/or sorafenib) treatment
- Previous therapy with bevacizumab, or chemotherapy also permitted
- Primary end point: PFS by RECIST criteria
- Progression per RECIST criteria: ≥20% growth in sum of diameters of target lesions
- Secondary end points: Safety, objective response rate, overall survival
BSC, best supportive care; MSKCC, Memorial Sloan Kettering Cancer Center; PFS, progression-free survival; RECIST, Response Evaluation Criteria In Solid Tumors; VEGFR-TKI, vascular endothelial growth factor receptor-tyrosine kinase inhibitor.
- Motzer RJ, Escudier B, Oudard S, et al; for the RECORD-1 Study Group. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer. 2010;116(18):4256-4265.
- Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247.