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Sorafenib in Advanced Soft Tissue Sarcoma
NCT00406601Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2006
- Primary completion
- Jun 2010
- Countries
- 1
- Sponsor
- Humanitas Research Hospital
- Modality
- Small Molecules
- Drugs
- sorafenib
- Conditions
- soft tissue sarcoma (STS)
01
Overview
Phase 2, open-label, single-arm trial of sorafenib in soft tissue sarcoma (STS), sponsored by Humanitas Research Hospital. Primary endpoint: Progression Free Survival Rate at 6 months. Started Nov 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Sorafenib
Sorafenib 800 mg/day orally on a continuous basis
03
Who it enrols
Adult patients with histologically documented, progressive, advanced or metastatic soft tissue sarcoma who have received prior anthracycline-based therapy, with ECOG PS 0-2 and adequate organ function.
04
Endpoints
Primary
Progression Free Survival Rate
Secondary
Overall Response Rate
Overall Disease Control Rate
Overall Survival
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