Sunitinib in Metastatic Renal Cancer

Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology

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.

This is a prospective, open label, multicenter phase II study to evaluate efficacy of Sunitinib (in advanced/metastatic renal cancer with non-clear cell histology (papillary or chromophobe).

Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks on treatment followed by 2 weeks off.

Treatment with the study drug will continue until tumor progression or unacceptable toxicity.

The planned total sample size for this study is 55 patients. Approximately 10 study sites will be involved.

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