An international expanded-access programme of everolimus: Addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy
Date
2012Author
Karakiewicz, Pierre I.
Bodrogi, Istvan
Miller, Kurt
Bavbek, Sevil E.
Gruenwald, Viktor
Pirotta, Nicoletta
Booth, Jocelyn
Rosamilia, Marianne
Anak, Oezlem
Hawkins, Robert
Knox, Jennifer J.
Blank, Christian U.
Castellano, Daniel
Rha, Sun Young
Bono, Petri
Larkin, James
Lee, Se-Hoon
Machiels, Jean-Pascal
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Background and objectives: The RECORD-1 trial established the clinical benefit of everolimus in patients with metastatic renal cell carcinoma (mRCC) after failure of initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) therapy. The REACT (RAD001 Expanded Access Clinical Trial in RCC) study was initiated to address an unmet medical need by providing everolimus prior to commercial availability, and also to further assess the safety and efficacy of everolimus in patients with VEGFr-TKI-refractory mRCC.
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