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Clinical Trial Summary

This is a phase I, single-center, non-randomized, 3+3 dose-escalation study of alpha lipoic acid given during chemotherapy-radiation in HNSCC patients with non-metastatic disease.


Clinical Trial Description

The study will be completed when the MTD and RP2D are determined. This will be either when 2 or more patients have a DLT at a particular dose level, or when 6 patients have completed treatment at the highest dose level (600 mg TID). The final 3 patients enrolled at the highest tolerated dose will also complete PK studies. ;


Study Design


Related Conditions & MeSH terms

  • HNSCC
  • Squamous Cell Carcinoma of Head and Neck

NCT number NCT04042935
Study type Interventional
Source University of Colorado, Denver
Contact
Status Completed
Phase Phase 1
Start date February 27, 2020
Completion date September 24, 2021

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