Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have had a biopsy confirming abnormal tissue growth (hyperplasia) in high-risk mouth areas such as the floor of the mouth, the movable part of the tongue, or the throat, OR any level of abnormal cell changes (dysplasia or hyperplasia) in a red patch (erythroplakia) in the mouth, OR mild to severe abnormal cell changes anywhere in the mouth or throat area.
• People who have a visible white or red patch (leukoplakia, erythroplakia, or a mixed red/white patch) in the mouth or throat that can be measured in two directions and is large enough (at least 4mm x 8mm) to allow a small punch biopsy to be taken from it.
• People aged 18 years or older at the time of signing consent.
• People whose kidneys, liver, and other organs are functioning adequately, confirmed by tests done within 14 days before the study start.
• People who are able to swallow a tablet whole (not crushed) and complete 12 weeks of twice-daily medication, as assessed by the treating doctor.
• People with a Body Mass Index (BMI) of 18.5 or above (a standard measure of body weight relative to height).
• People who are sexually active and able to become pregnant who agree to use an adequate form of contraception — such as a hormonal method used continuously for at least 3 months before the study, a barrier method, or abstinence — for the entire time they are in the study.
• People who voluntarily provide written consent before any study-related activities begin.

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant.
• People who have been diagnosed with Type 1 or Type 2 diabetes and are currently being treated with insulin or any diabetes medication. (People with Type 2 diabetes managed through diet and/or exercise alone may still be considered, provided all other criteria are met.)
• People who are currently taking another experimental drug that has not been approved by the FDA for any use.
• People who have had an allergic reaction to drugs with a similar chemical or biological makeup to the study medications ACTOplus Met, pioglitazone, or metformin.
• People for whom a biopsy would not be medically safe, as the study requires a small 4mm punch biopsy of the lesion and nearby normal tissue both before and after the 12-week treatment period.
• People with a history of bladder cancer, including non-invasive (in situ) bladder cancer.
• People who have had an invasive cancer — other than certain skin cancers (non-melanoma) or non-invasive cervical cancer — that was active within the 18 months before the study baseline visit. (People whose cancer was fully treated and has shown no signs of returning in the 18 months before the baseline visit may still be considered.)

Important: Always verify eligibility with the trial site directly before applying.