Spots Global Cancer Trial Database for Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
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Trial Identification
Brief Title: Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Official Title: Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Study ID: NCT05727761
Conditions
Interventions
Study Description
Brief Summary: This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks. The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin. Outcomes are defined as are a reduction of the leukoplakia grade in \> 50% of treated participants and a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions. In addition, participants who show clinical and histologic improvement should correlate with a significant reduction of Ki-67 proliferative indices in lesions of these participants as compared to baseline.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Minnesota, Minneapolis, Minnesota, United States
Contact Details
Name: Frank Ondrey
Affiliation: University of Minnesota
Role: PRINCIPAL_INVESTIGATOR
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