- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05727761
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
April 22, 2024 updated by: University of Minnesota
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Beverly Wuertz
- Phone Number: 612-625-3090
- Email: knier003@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
Contact:
- Beverly Wuertz
- Phone Number: 612-625-3090
- Email: knier003@umn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: oral leukoplakia patients
36 total high risk oral leukoplakia patients.
|
Treatment with pioglitazone-metformin (15mg/500mg) twice a day for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical change in leukoplakia
Time Frame: after 12 weeks of intervention or at early termination.
|
a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions
|
after 12 weeks of intervention or at early termination.
|
histologic change in leukoplakia
Time Frame: after 12 weeks of intervention or at early termination.
|
reduction of the leukoplakia grade in > 50% of treated participants
|
after 12 weeks of intervention or at early termination.
|
Change in Ki-67
Time Frame: After 12 weeks of intervention or at early termination
|
Ki-67 proliferative indices in lesions
|
After 12 weeks of intervention or at early termination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frank Ondrey, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 15, 2024
Primary Completion (Estimated)
March 15, 2026
Study Completion (Estimated)
March 15, 2027
Study Registration Dates
First Submitted
January 19, 2023
First Submitted That Met QC Criteria
February 4, 2023
First Posted (Actual)
February 14, 2023
Study Record Updates
Last Update Posted (Actual)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENT-2022-31139
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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