oral premalignant lesions MedDRA version: 9.1 Level: LLT Classification code 10024396
Conditions
Interventions
Trade Name: ACTOS*50CPR 15MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Pioglitazone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males or females with a suspected or histologically confirmed oral premalignant lesion of 8 mm or greater and width of 3 mm or greater in size. Age ≥18 years Life expectancy is > 6 months ECOG performance status is 0 or 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -active cancer or carcinoma in situ of the head and neck. -contraindication to biopsy. -congestive heart failure (New York Heart Association (NYHA) Class II-IV), uncontrolled hypertension (systolic >150 or diastolic >100), or unstable angina. The participant has any history of congestive heart failure or history of myocardial infarction within the past 6 months. The participant exhibits clinical evidence of active liver disease or history of chronic liver disease The participant has > CTCAE Grade 1 edema The participant has known diabetes and is on insulin or oral agents. The participant is receiving medical therapy for dysregulated blood sugar. The participant has a random blood glucose level >200 mg/dl.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the clinical and histologic response of oral premalignant lesions to 24 weeks of therapy with pioglitazone, defined as 50% or greater reduction in the measured product of perpendicular dimensions of the target lesion, or improvement in the degree of dysplasia or hyperplasia.;Secondary Objective: To determine the degree of change of putative biomarkers: PPAR gamma, cyclin D1 and p21 as indirect measures of pharmacological effect; TUNEL and Ki-67, transglutaminase and involucrin, 15-PGDH, loss of heterozygosity (LOH); To determine the degree of change of C-reactive protein (CRP) in serum; To assess tobacco and alcohol use among trial participants, To assess the safety of this agent in this population.;Primary end point(s): percentage of clinical or histological responses | — |
Countries
Italy
Outcome results
None listed