Information obtained from ClinicalTrials.gov on May 16, 2013 Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01034878 ONC-2008-004 NCT01034878 Sunitinib in Metastatic Renal Cancer Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology Istituto Clinico Humanitas Other Istituto Clinico Humanitas Italy: Ministry of Health No Sunitinib is the registered treatment for first-line therapy of metastatic clear-cell carcinoma of the kidney.Data from the Expanded Access Study have shown activity also in non-clear cell renal cancer (NCCRC). The aim of this study is to prospectively evaluate the anti-tumor activity and safety of sunitinib as a first-line therapy in metastatic NCCRC patients. Recruiting December 2009 November 2011 February 2010 Phase 2 Interventional Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment The antitumor activity in terms of progression free survival two years No To evaluate the objective response rate two years No To evaluate the toxicity and the safety profile two years No To evaluate the overall survival two years No 1 55 Metastatic Renal Cancer With Non-clear Cell Drug Sunitinib Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks of treatment followed by 2 weeks without treatment. Inclusion Criteria: - Histologically proven diagnosis of metastatic renal cancer with non-clear cell - No previous treatment Exclusion Criteria: - Prior treatment with an antiangiogenetic compound - Symptomatic and/or unstable pre-existing brain metastases - Severe or uncontrolled cardiovascular diseases Both 18 Years N/A No Armando Santoro, MD Principal Investigator Istituto Clinico Humanitas Armando Santoro, MD +39028224 4080 armando.santoro@humanitas.it Andrea Zucali, MD +39028224 4080 andrea.zucali@humanitas.it Istituto Clinco Humanitas

Rozzano Milano 20089 Italy

Recruiting Armando Santoro, MD +30028224 4080 armando.santoro@humanitas.it Andrea Zucali, MD +30028224 4080 andrea.zucali@humanitas.it Andrea Zucali, MD Sub-Investigator Italy September 2010 September 1, 2010 December 17, 2009 Armando Santoro, MD Istituto Clinico Humanitas No No Carcinoma, Renal Cell Kidney Neoplasms Sunitinib