NCT00889057

Sorafenib in Relapsed High Grade Osteosarcoma

Phase II, Open Label, Non-randomized Study of Second or Third Line Treatment With Sorafenib (BAY 43-9006) in Patients Affected by Relapsed High-grade Osteosarcoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Italian Sarcoma Group · Network
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Aim of this exploratory phase II study is to assess the clinical activity of sorafenib as single agent, in terms of percentage of patients with high grade advanced osteosarcoma free from progression following 4 months of therapy

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	sorafenib	400 mg bid until progression or inacceptable toxicity

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-12-01
• Completion: 2011-06-01
• First posted: 2009-04-28
• Last updated: 2013-03-28

Locations

4 sites across 1 country: Italy