drugset / Trial / NCT02325401

Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT02325401 ↗

Phase 1 Completed 20 enrolled University of Cincinnati
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to test the safety of adding metformin to standard of care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments and radiation for 7 weeks. Metformin is a medication that is currently used to treat diabetes. Increasing amounts of metformin will be given to groups of patients already receiving normal treatment for their cancer to see if metformin causes any good effects by killing your cancer or bad effects (side effects).

Timeline

Start
2015-05-11
Primary completion
2017-12-26
Completion
2020-02-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 2000 mg Oral
Subject Metformin Small molecule 2550 mg Oral
Subject Metformin Small molecule 3000 mg Oral
Background Cisplatin Other / unclassified 100 mg/m2 —

Indications