Sunitinib in Metastatic Renal Cancer
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
- To evaluate the objective response rate [ Time Frame: two years ] [ Designated as safety issue: No ]
- To evaluate the toxicity and the safety profile [ Time Frame: two years ] [ Designated as safety issue: No ]
- To evaluate the overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]
|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|