Von Hippel-Lindau Disease Clinical Trial
Official title:
A Single-arm, Phase II Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease
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.
Treatment with sunitinib, 50 mg PO daily, 6 weeks courses with schedule 4/2 (4 weeks of
treatment followed by 2 weeks of rest).
Treatment until disease progression or unacceptable toxicity.
Dose reduction depending on type and severity of toxicity. At the end of treatment period
(after 8 courses), responding and well tolerating patients will be allowed to receive
sunitinib upon investigator's opinion.
Follow-up for up to 24 months from inclusion.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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