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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional




Official Title: A Single-arm, Phase II Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease

Brief 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.