At a glance
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M4OC-Prevent: Metformin for Oral Cancer Prevention
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
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
Timeline
Arms & Interventions
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.
Interventions
Correlative studies
Given PO