Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium
OBJECTIVES:
Primary
- Determine the response rate in patients with progressive metastatic transitional cell
carcinoma of the urothelium treated with sunitinib malate.
- Determine the safety of this regimen in these patients.
Secondary
- Determine the time to disease progression in patients treated with this regimen.
- To determine time to tumor progression (TTP) for sunitinib malate on a continuous
dosing schedule for treatment of metastatic urothelial carcinoma.
- To estimate sunitinib and SU012662 trough plasma concentration (Ctrough) data for
the continuous daily schedule and to determine potential association with efficacy
and safety.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate as measured by RECIST criteria
2 years
No
Dean F. Bajorin, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
06-081
NCT00397488
September 2006
February 2012
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |