CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Metformin +2 moredrug
Likely dose
Metformin 2000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02325401
NCT02325401Phase 1Completed
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A Phase I Dose-finding Study of Metformin in Combination With Concurrent Cisplatin and Radiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

University of Cincinnati·interventional·Posted Dec 25, 2014·Updated Jun 11, 2020

In Brief

A Phase 1 clinical trial evaluating Metformin, Cisplatin, and 1 other intervention for Head and Neck Cancer. Completed, enrolled 20 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 25, 2014
Enrollment StartMay 11, 2015
Primary CompletionDec 26, 2017
Study CompletionFeb 21, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.5 years ago

Interventions

Metformindrug

Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.

Cisplatindrug

Dosed at 100mg/m2 on days 1, 22, and 43

Radiation Therapyradiation

70 Gy in 2 Gy once daily fractions of 35 fractions