Phase IIB Randomized, Placebo Controlled Trial of Pioglitazone for Oral Premalignant Lesions. An Inter-Consortium Collaborative Study. - ND

Conditions: oral premalignant lesions
MedDRA version: 9.1Level: LLTClassification code 10024396

Registration Number: EUCTR2009-014833-26-IT

Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

-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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures