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NCT02581137 · ClinicalTrials.gov registry record · Phase 2
Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion
A Phase 2 study of Oral Leukoplakia and Oral Cavity Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 4
- Study locations
NCT02581137: Active Phase 2 study of Oral Leukoplakia and Oral Cavity Carcinoma, sponsored by National Cancer Institute (NCI).
NCT02581137 is a Phase 2 study of Oral Leukoplakia and Oral Cavity Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 26 participants, below the 44-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (41% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02581137, a Phase 2 study of Oral Leukoplakia and Oral Cavity Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase IIa trial studies how well metformin hydrochloride works in preventing oral cancer in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia). Oral premalignant lesions look like red or whitish plaques or lesions in the mouth that do not rub off and can be associated with a higher risk of cancer. Metformin hydrochloride may help prevent oral cancer from forming in patients with an oral premalignant lesion.
Primary Outcome
Number of participants with complete and partial clinical response to metformin intervention. Criteria for complete and partial clinical response are: Complete Response (CR): Disappearance of all evidence of lesion(s). Partial Response (PR): Greater than or equal to 50% reduction in the sum of the products of diameters of lesion(s) measurable at baseline. Non-measurable lesion(s) may not increase greater than or equal to 25% in size and no new lesion may appear.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Metformin Hydrochloride
Study Locations (4)
British Columbia
- BC Cancer Research Centre - Vancouver
- University of British Columbia Hospital - Vancouver
California
- UC San Diego Medical Center - Hillcrest - San Diego
Minnesota
- University of Minnesota/Masonic Cancer Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2016-06-10 |
| Est. Completion | 2026-12-19 |
| Phase | Phase 2 |
What the registry record for NCT02581137 still lists
NCT02581137 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 44-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (41% lower).
The record links to 4 conditions, with Oral Leukoplakia appearing as the primary indexed condition, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02581137 reports a single indexed study location in British Columbia, California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT02581137 about?
NCT02581137 is a clinical study titled "Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion". This phase IIa trial studies how well metformin hydrochloride works in preventing oral cancer in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia). Oral premalignant lesions look like red or whitish plaques or lesions in the mouth that do not rub off and can be associated...
What is the current status of trial NCT02581137?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2016-06-10. Estimated completion is 2026-12-19.
What conditions does trial NCT02581137 study?
This clinical trial studies the following conditions: Oral Leukoplakia, Oral Cavity Carcinoma, Erythroplakia, Hyperplasia.
What interventions are being tested in trial NCT02581137?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Metformin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02581137?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02581137 being conducted?
This trial has 4 study locations across California, Minnesota, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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