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NCT00099021 · ClinicalTrials.gov registry record · Phase 2

Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
21
Enrollment target

NCT00099021: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00099021 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00099021, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
21 participants
Enrollment target

Study 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.

Primary Outcome

Overall Response= reviewing both the clinical and histological responses and assigning the worst category. Complete Response (CR) = Clinical CR and Histologic CR, or Histologic CR Partial Response (PR) = Clinical CR or PR and Histologic PR or Stable Disease (SD) Stable Disease (SD) = Clinical SD and Histologic PR or SD Progressive Disease (PD) = Clinical PD and/or Histologic PD

Interventions

  • DRUG pioglitazone hydrochloride

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2003-06
Est. Completion 2008-06-27
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00099021 record still lists

NCT00099021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 1 intervention - of which pioglitazone hydrochloride is the first listed.

NCT00099021 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00099021 about?

NCT00099021 is a clinical study titled "Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia". 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 ...

What is the current status of trial NCT00099021?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2003-06. Estimated completion is 2008-06-27.

What interventions are being tested in trial NCT00099021?

The interventions under investigation include: pioglitazone hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00099021?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00099021's enrollment target sits among peer trials

21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00099021, the US trial registry maintained by the National Library of Medicine. NCT00099021 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.