CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
pioglitazone hydrochloridedrug
Likely dose
Pioglitazone hydrochloride orally (specific dose not specified)AI-extracted
Key inclusion· 5
  • ✓Diagnosis of oral cavity or oropharyngeal leukoplakia with biopsy-proven hyperplasia in high-risk areas (floor of mouth, mobile tongue, oropharynx) or any erythroplakia lesion
  • ✓Mild, moderate, or severe dysplasia at any site of oral cavity or oropharynx within the lesion
  • ✓Measurable lesion clinically characterized by leukoplakia, erythroplakia, or erythroleukoplakia, assessable by bi-directional measurements
  • ✓Life expectancy greater than 3 months
Key exclusion· 7
  • ✕No prior radiotherapy to the oral cavity
  • ✕No prior thiazolidinediones
  • ✕No invasive carcinoma within past 60 months except nonmelanoma skin cancer or carcinoma in situ of cervix
  • ✕No concurrent malignancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00099021
NCT00099021Phase 2Completed
CompareCT.gov

A Phase IIa Cancer Prevention Trial of the PPAR Gamma Agonist Pioglitazone in Oral Leukoplakia

National Cancer Institute (NCI)·interventional·Posted Dec 9, 2004·Updated Feb 11, 2022

In Brief

A Phase 2 clinical trial evaluating pioglitazone hydrochloride for Head and Neck Cancer and Oral Leukoplakia. Completed, enrolled 21 participants across 1 site.

Detailed Summary

This phase II trial studies how well pioglitazone hydrochloride works in preventing head and neck cancer in patients who have oral leukoplakia. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of pioglitazone hydrochloride may be effective in preventing head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Oral Leukoplakia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 9, 2004
Enrollment StartJun 1, 2003
Primary CompletionJun 27, 2008
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 21.6 years ago

Interventions

pioglitazone hydrochloridedrug

Given PO