E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
oral premalignant lesions |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024396 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
percentage of clinical or histological responses |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |