drugset / Trial / NCT01168440

Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease

NCT01168440 ↗

NaSingle-groupOpen-labelTreatment

Summary

VHL patients may benefit from sunitinib. This study will investigate the following objectives : PRIMARY OBJECTIVE * To determine the objective response rate according to RECIST criteria, in VHL patients with advanced tumors or tumors untreatable by other means, and treated with sunitinib. SECONDARY OBJECTIVES * To evaluate the safety and tolerability of sunitinib in VHL patients according to the NCI-CTC criteria Version 3.0. * To determine the following time-to-event endpoints: overall survival, time to disease progression, progression free survival, time to response and duration of response. * To evaluate quality of life in VHL patients receiving sunitinib.

Timeline

Start
2010-03
Primary completion
2011-02
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Sunitinib Small molecule 50 mg Oral