Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

• Drug: Axitinib (AG-013736)
  
  axitinib will be given at a starting dose of 5 mg BID with continuous dosing
• Drug: Sorafenib
  
  sorafenib will be given at a dose of 400 mg BID continuous dosing

• Experimental: A
  
  Intervention: Drug: Axitinib (AG-013736)
• Active Comparator: B
  
  Intervention: Drug: Sorafenib

• Grünwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
• Hutson TE, Lesovoy V, Al-Shukri S, Stus VP, Lipatov ON, Bair AH, Rosbrook B, Chen C, Kim S, Vogelzang NJ. Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1287-94. doi: 10.1016/S1470-2045(13)70465-0. Epub 2013 Oct 25.

Inclusion Criteria:

• Histologically documented metastatic renal cell cancer with a component of clear cell histology.
• Evidence of measurable disease.
• Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.

Exclusion Criteria:

• Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
• Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.