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Phase I/II and Phase II Clinical Trials of Axitinib for Selected Cancers ...

Phase I/II and Phase II Clinical Trials of Axitinib for Selected Cancers ...

Phase I/II and Phase II Clinical Trials of Axitinib for Selected Cancers ...

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NCCN <strong>Axitinib</strong> RFP: 20DEC10References1. Investigator's Brochure: AG-013736. October 2010. Pfizer.2. Hu-Lowe DD, Zou HY, Grazzini ML, et al. Nonclinical antiangiogenesis <strong>and</strong>antitumor activities <strong>of</strong> axitinib (AG-013736), an oral, potent, <strong>and</strong> selective inhibitor<strong>of</strong> growth factor receptor tyrosine kinases 1, 2, 3. Clin Cancer Res.2008;14:7272-83.3. Rugo HS, Herbst RS, Liu G, et al. <strong>Phase</strong> I trial <strong>of</strong> the oral antiangiogenesis agentAG-013736 in patients with advanced solid tumors: pharmacokinetic <strong>and</strong> clinicalresults. J Clin Oncol. 2005;23:5474-83.4. Rixe O, Bukowski R, Michaelson MD, et al. <strong>Axitinib</strong> treatment in patients withcytokine-refractory metastatic renal cell cancer: a phase <strong>II</strong> study. Lancet Oncol.2007;8:975-84.5. Rini BI, Wilding G, Hudes G, et al. <strong>Phase</strong> <strong>II</strong> study <strong>of</strong> axitinib in sorafenibrefractorymetastatic renal cell carcinoma. J Clin Oncol. 2009;27:4462-8.6. Cohen EE, Rosen LS, Vokes EE, et al. <strong>Axitinib</strong> is an active treatment <strong>for</strong> allhistologic subtypes <strong>of</strong> advanced thyroid cancer: results from a phase <strong>II</strong> study. JClin Oncol. 2008;26:4708-13.7. Fruehauf JP, Lutzky J, McDermott D Fea. <strong>Axitinib</strong> (AG-013736) in patients withmetastatic melanoma: a phase <strong>II</strong> study. J Clin Onco 26:2008 (May 20 suppl;abstr 9006).8. Schiller JH, Larson T, Ou SH, et al. Efficacy <strong>and</strong> safety <strong>of</strong> axitinib in patients withadvanced non-small cell lung cancer: results from a phase <strong>II</strong> study. J Clin Oncol.2009;27:3836-41.9. Rixe O, Dutcher J, Motzer R, Wilding G, Stadler WM, Garrett M, Pithavala Y, KimS, Tarazi J, Rini BI. Diastolic blood pressure (dBP) <strong>and</strong> pharmacokinetics (PK) aspredictors <strong>of</strong> axitinib efficacy in metastatic renal cell cancer (mRCC). J Clin Oncol27: 2009 (suppl; abstr 5045).CONFIDENTIALPage 16 <strong>of</strong> 16

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