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Sorafenib in Non-GIST Sarcomas
NCT00245102Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2005
- Primary completion
- Mar 2011
- Countries
- 1
- Sponsor
- National Cancer Institute
- 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 National Cancer Institute. Primary endpoint: Overall Response Rate up to 4 weeks. Started Sep 2005; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Sorafenib
Patients receive oral sorafenib twice daily.
03
Who it enrols
Patients with metastatic, locally advanced, or recurrent sarcoma (excluding GIST) who have received no more than 1 prior chemotherapy regimen (or 3 for specific subtypes).
04
Endpoints
Primary
Overall Response Rate
Secondary
Progression-Free Survival
Overall Survival
Pharmacokinetics
Frequency of B-raf mutations
Ras-raf kinase pathway activation
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