Clinical Trial Design

The AFINITOR^® (everolimus) tablets pivotal study: RECORD-1 Trial Design

AFINITOR is the proven therapy for patients with advanced renal cell carcinoma whose disease has progressed on or after treatment with VEGF^**-targeted therapy. The AFINITOR pivotal trial is the first prospective, randomized, placebo-controlled trial to demonstrate a therapeutic benefit for patients after initial sunitinib or sorafenib failure.¹

Overview

• A completed, randomized, double-blinded, placebo-controlled, multicentre Phase III study in patients with advanced renal cell carcinoma (RCC) who progressed on VEGF tyrosine kinase inhibitor (TKI) therapy¹

Primary endpoint

• Progression-free survival

Enrollment criteria

• Patients with advanced renal cell carcinoma (progressive disease) on or within six months of prior sunitinib and/or sorafenib treatment
• Histological or cytological evidence of clear-cell component of advanced renal cell carcinoma

Crossover design analysis

• No statistically significant treatment-related difference in overall survival was noted, although there was a trend in favor of AFINITOR (HR 0.87 [0.65, 1.17]; P=0.177)
• Crossover to open-label AFINITOR following disease progression for patients allocated to placebo confounded the detection of any treatment-related difference in overall survival

View the key data on AFINITOR, including results for progression-free survival and demonstrated clinical efficacy.

Next: Efficacy

*MSKCC: Memorial Sloan-Kettering Cancer Center
^**VEGF: vascular endothelial growth factor

References:
1. AFINITOR [summary of product information]. Basel, Switzerland: Novartis Pharma AG.
2. Motzer RJ, Escudier B. Oudard S, et al; for the RECORD-1 Study Group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomized, placebo-controlled phase III trial. Lancet. 2008; 372:449-456.