Sunitinib in Metastatic Renal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01034878|
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : December 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Renal Cell||Drug: Sunitinib||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034878
|Istituto Clinco Humanitas|
|Rozzano, Milano, Italy, 20089|
|Principal Investigator:||Armando Santoro, MD||Istituto Clinico Humanitas|