Metformin for Preventing Oral Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byScott M Lippman

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests if metformin hydrochloride can prevent oral cancer in patients with specific mouth lesions. These lesions can increase cancer risk, and metformin may help by slowing cell growth and affecting proteins related to cancer development. Metformin, widely used as a diabetes medication, has recently been reported to reduce cancer risk and improve outcomes in certain cancers.

Eligibility Criteria

This trial is for people with certain mouth lesions that could turn into cancer, specifically oral leukoplakia or erythroplakia. Participants should have a life expectancy over 3 months, be able to take pills, and not have diabetes treated with insulin or other drugs. They must also agree to use birth control and not have had any recent treatments for other cancers.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

Measurable disease - minimum lesion size of 8 x 3 mm before initial biopsy

Leukocytes >= 3,000/microliter

+10 more

Exclusion Criteria

Participants may not be receiving any other investigational agents within past 3 months

I had head and neck cancer but was treated successfully over a year ago.

I have diabetes and am taking insulin or pills for it.

+10 more

Participant Groups

The study is testing if Metformin Hydrochloride can prevent mouth cancer in patients with premalignant lesions. It's a phase IIa trial where the effects of the drug will be monitored through lab tests to see if it stops these lesions from becoming cancerous.

1Treatment groups

Experimental Treatment

Group I: Prevention (extended-release metformin hydrochloride)Experimental Treatment2 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.

Metformin Hydrochloride is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Metformin Hydrochloride for: