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Nelfinavir in Head and Neck Squamous Cell Carcinoma
NCT02207439Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2014
- Primary completion
- May 2021
- Countries
- 1
- Sponsor
- Abramson Cancer Center
- Modality
- Small Molecules
- Drugs
- nelfinavir
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, open-label, single-arm trial of nelfinavir in head and neck squamous cell carcinoma (HNSCC), sponsored by Abramson Cancer Center. Primary endpoint: Locoregional Control at 5 years. Started Jul 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Single Arm Phase 2
Patients receive a Nelfinavir lead-in followed by concurrent Nelfinavir and chemoradiation.
03
Who it enrols
Adult patients (18+) with locally advanced (Stage III, IVa, or IVb), p16-negative squamous cell carcinoma of the head and neck, eligible for definitive chemoradiation. Patients must have an ECOG performance status of 0-2 and must not have received prior head and neck radiation or recent chemotherapy. Exclusions include known HIV, pregnancy, and use of specific contraindicated medications.
04
Endpoints
Primary
Locoregional Control
Secondary
Decrease in Hypoxia From Nelfinavir
Change in Glucose Metabolism From Nelfinavir
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