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Clinical Trial DesignRECORD-1 clinical trial. Advanced Renal Cell cancer treatment with Oral RAD001 (everolimus) given Daily.

AFINITOR: PFS proven in a diverse patient population1

AFINITOR (everolimus) study design in RECORD-1

Enrollment criteria1,2

  • 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
Abbreviations:
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.
References:
  1. 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.
  2. 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.