NCT01168440

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Von Hippel-Lindau Disease

Interventions

Type	Name	Description
DRUG	Sunitinib	Sunitinib, 50 mg PO daily, 6 weeks courses with schedule 4/2 (4 weeks of treatment followed by 2 weeks of rest).

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-07-23
• Last updated: 2012-09-13

Locations

3 sites across 1 country: France