Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 8:56 AM
Study NCT ID:
NCT05237960
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2022-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
M4OC-Prevent 2.0: Phase IIb Trial of Metformin for Oral Cancer Prevention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose patients absorb from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood. This trial may help researchers determine if metformin can stop changes in the mouth that are related to pre-cancer growths in the mouth.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the histological response to metformin hydrochloride (metformin) intervention in the target lesion.
SECONDARY OBJECTIVES:
I. Clinical response to metformin intervention in the target lesion. II. Effect of metformin on cell proliferation (Ki67) and its molecular targets (pS6 and nuclear YAP) in the target lesion.
III. Metformin effect on serum metabolic markers (C-peptide, glucose and HbA1c).
IV. Trough plasma metformin concentrations.
EXPLORATORY OBJECTIVES:
I. Expression of dysregulated molecular mechanisms in the target lesion, including, in order of priority, p53, PTEN, p16, EGFR, and pEGFR.
II. Immune cell infiltration and markers of inflammation in the target lesion. III. Analysis of genomic alterations in the target lesion and blood deoxyribonucleic acid (DNA).
IV. Microbiome in oral rinses.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive extended release metformin hydrochloride orally (PO) once daily (QD) for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and biopsy at baseline and week 24.
ARM II: Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and biopsy at baseline and week 24.
After completion of study treatment, patients are followed for up to 3 weeks.
I. To determine the histological response to metformin hydrochloride (metformin) intervention in the target lesion.
SECONDARY OBJECTIVES:
I. Clinical response to metformin intervention in the target lesion. II. Effect of metformin on cell proliferation (Ki67) and its molecular targets (pS6 and nuclear YAP) in the target lesion.
III. Metformin effect on serum metabolic markers (C-peptide, glucose and HbA1c).
IV. Trough plasma metformin concentrations.
EXPLORATORY OBJECTIVES:
I. Expression of dysregulated molecular mechanisms in the target lesion, including, in order of priority, p53, PTEN, p16, EGFR, and pEGFR.
II. Immune cell infiltration and markers of inflammation in the target lesion. III. Analysis of genomic alterations in the target lesion and blood deoxyribonucleic acid (DNA).
IV. Microbiome in oral rinses.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive extended release metformin hydrochloride orally (PO) once daily (QD) for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and biopsy at baseline and week 24.
ARM II: Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and biopsy at baseline and week 24.
After completion of study treatment, patients are followed for up to 3 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-00596 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| Pending12 | OTHER | University of Arizona Cancer Center - Prevention Research Clinic | View | |
| UAZ21-07-01 | OTHER | DCP | View | |
| P30CA023074 | NIH | None | https://reporter.nih.gov/quic… | View |
| UG1CA242596 | NIH | None | https://reporter.nih.gov/quic… | View |