Sunitinib in Metastatic Renal Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology|
- 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 ]
|Study Start Date:||December 2009|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
50 mg once daily 6 weeks cycle 4 weeks on and 2 weeks off
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.
Other Name: Sutent
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034878
|Istituto Clinco Humanitas|
|Rozzano, Milano, Italy, 20089|
|Principal Investigator:||Armando Santoro, MD||Istituto Clinico Humanitas|