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Pralatrexate in Recurrent/Metastatic HNSCC
NCT01183065Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2010
- Primary completion
- Apr 2014
- Countries
- 1
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Modality
- Small Molecules
- Drugs
- pralatrexate
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, open-label, single-arm trial of pralatrexate in head and neck squamous cell carcinoma (HNSCC), sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoint: Overall Response Rate at 2 years. Started Aug 2010; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Pralatrexate Arm
Pralatrexate with Vitamin B12 and Folic Acid supplementation
03
Who it enrols
Patients with histopathologically confirmed recurrent/metastatic HNSCC who have received prior systemic chemotherapy, have measurable disease, and adequate organ function.
04
Endpoints
Primary
Overall Response Rate
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