CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 26 enrolled / 26 target
Drug / intervention
Metformin Hydrochloride +1 moredrug
Likely dose
Not stated in 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/NCT02581137
NCT02581137Phase 2ActiveUpdate Overdue (0.2/mo)Completion was 104mo ago

M4OC-Prevent: Metformin for Oral Cancer Prevention

National Cancer Institute (NCI)·interventional·Posted Oct 20, 2015·Updated Jun 26, 2026

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis and Metformin Hydrochloride for Erythroplakia and 3 related conditions. Active but no longer recruiting, targeting 26 participants across 4 sites in 2 countries.

Signals

Enrollment appears stalled

Detailed Summary

This phase IIa trial studies how well metformin hydrochloride works in preventing oral cancer in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia). Oral premalignant lesions look like red or whitish plaques or lesions in the mouth that do not rub off and can be associated with a higher risk of cancer. Metformin hydrochloride may help prevent oral cancer from forming in patients with an oral premalignant lesion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2Active
201620172018201920202021202220232024202520262027
First PostedOct 20, 2015
Enrollment StartJun 10, 2016
Primary CompletionOct 12, 2017
Study CompletionDec 19, 2026
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.7 years ago

Arms & Interventions

Prevention (extended-release metformin hydrochloride)experimental

Patients receive extended-release metformin hydrochloride PO QD for 2 weeks and then BID for 10-12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisDrug: Metformin Hydrochloride

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Metformin Hydrochloridedrug

Given PO