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Vismodegib in Advanced Chondrosarcomas
NCT01267955Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Dec 2010
- Primary completion
- Jun 2018
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules
- Drugs
- vismodegib
- Conditions
- chondrosarcoma
01
Overview
Phase 2, open-label, single-arm trial of vismodegib in chondrosarcoma, sponsored by National Cancer Institute. Primary endpoint: Clinical Benefit Rate at 6 months. Started Dec 2010; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (vismodegib)
Patients receive vismodegib PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
03
Who it enrols
Patients with advanced, metastatic, or unresectable chondrosarcoma who have progressed on prior therapy (up to 3 lines), with adequate organ function and performance status.
04
Endpoints
Primary
Clinical Benefit Rate
Secondary
Progression-free Survival
Overall Survival
Duration of Response
Mutational Status of Patched 1 and Smoothened
Expression Pattern of Hedgehog Signaling Molecules
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