Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099021
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2004-12-08
Brief Title:
Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase IIa Cancer Prevention Trial of the PPAR Gamma Agonist Pioglitazone in Oral Leukoplakia
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
PRIMARY OBJECTIVES
I Determine whether pioglitazone pioglitazone hydrochloride reverses leukoplakia in patients with hyperplastic or dysplastic oral cavity or oropharyngeal leukoplakia
SECONDARY OBJECTIVES
I Determine the safety and tolerability of this drug in these patients
OUTLINE This is an open-label study
Patients receive pioglitazone hydrochloride orally PO once daily QD for 12 weeks in the absence of disease progression unacceptable toxicity or the development of carcinoma
Patients are followed up at 4 8 12 and 16 weeks
I Determine whether pioglitazone pioglitazone hydrochloride reverses leukoplakia in patients with hyperplastic or dysplastic oral cavity or oropharyngeal leukoplakia
SECONDARY OBJECTIVES
I Determine the safety and tolerability of this drug in these patients
OUTLINE This is an open-label study
Patients receive pioglitazone hydrochloride orally PO once daily QD for 12 weeks in the absence of disease progression unacceptable toxicity or the development of carcinoma
Patients are followed up at 4 8 12 and 16 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CN15000 | OTHER | US NIH GrantContract Award Number | None |
| NCI-2009-00862 | REGISTRY | None | None |
| CDR0000393562 | None | None | None |
| 2001LS068 | None | None | None |
| 0109 M 07254 | OTHER | None | None |
| N01-CN-15000 | OTHER | None | None |