drugset / Trial / NCT02207439

Phase II Trial of Nelfinavir With Concurrent Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

NCT02207439

Phase 2 Completed 18 enrolled Abramson Cancer Center at Penn Medicine
NaSingle-groupOpen-labelDiagnostic

Summary

This is a Phase II trial of definitive chemoradiotherapy (CTRT) given with the protease inhibitor,Nelfinavir (NFV), in patients with locally advanced head and neck. Eligible patients will receive a "lead-in" period of Nelfinavir (1250 mg po bid) for 7-14 days prior to initiation of CTRT. Nelfinavir will then be given concurrently with platinum-based chemotherapy and radiation therapy (planned total dose of 70 Gy over 7 weeks).

Timeline

Start
2014-07
Primary completion
2021-05
Completion
2022-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Nelfinavir Other / unclassified 1250 mg Oral