Combination treatment of pioglitazone and metformin for high-risk oral lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase IIa clinical trial investigates the effects of a combination treatment using pioglitazone and metformin on patients with oral leukoplakia, a precancerous condition. Participants will receive 15mg of pioglitazone and 500mg of metformin twice daily for 12 weeks. The primary goal is to assess clinical and histologic changes in leukoplakia, aiming for a significant reduction in lesion grade and size. The study will also evaluate the correlation between clinical improvement and changes in Ki-67 proliferative indices in the lesions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Biopsy proven hyperplasia in high risk anatomic areas (floor of mouth, mobile tongue, oropharynx). Hyperplasia or dysplasia of any grade in any erythroplakia lesion. Mild, moderate or severe dysplasia within the lesion at any site of the oral cavity or oropharynx.
* Must have objective evidence of oral leukoplakia that is measurable in 2 dimensions per RECIST. The lesion(s) may be clinically characterized by leukoplakia, erythroplakia, erythro/leukoplakia. Lesions may be located in the oral cavity or oropharynx. However, the index lesion must be located in an anatomic site accessible by punch biopsy and be a minimum of 4mm x 8 mm to permit a 4mm punch biopsy.
* Age 18 years or older at the time of consent.
* Evidence of adequate organ function within 14 days prior to Day 1
* Able to comply with treatment (i.e. able to swallow a tablet whole, not crushed) and complete a 12 week course of twice daily medication as required by this study in the opinion of the treating investigator.
* Body mass index (BMI) is ≥ 18.5.
* Sexually active persons of child-bearing potential agrees to use adequate contraception (a hormonal method that has been in continual use for a minimum of 3 months prior to the study screening visit, a barrier method, or abstinence) for the duration of study participation.
* Provides voluntary written consent prior to the performance of any research related activity.

Exclusion Criteria:

* Pregnant or breastfeeding or planning to become pregnant.
* A concurrent diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent. Participants whose Type II diabetes is controlled with diet and/or exercise alone are eligible provided they meet all other eligibility criteria.
* Participant is taking another investigational agent (not approved by the FDA for any indication).
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ACTOplus Met, pioglitazone or metformin.
* Any contraindication to biopsy - this study requires a 4 mm punch biopsy of a lesion and of nearby normal tissue prior to treatment and at the end of the 12 week treatment period.
* History of bladder cancer, including in situ bladder cancer.
* History of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) active within 18 months prior to the baseline study visit. (Participants who have a history of cancer that was curatively treated without evidence of recurrence in the 18 months prior to the baseline study visit are considered eligible).

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• HealthPartners
  Saint Paul, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Frank Ondrey — University of Minnesota
• Study coordinator: Beverly Wuertz
• Email: knier003@umn.edu
• Phone: 612-625-3090

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.