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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
Istituto Clinco Humanitas
Rozzano, Milano, Italy
The antitumor activity in terms of progression free survival
Time frame: two years
To evaluate the objective response rate
Time frame: two years
To evaluate the toxicity and the safety profile
Time frame: two years
To evaluate the overall survival
Time frame: two years
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