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NCT02917629 · ClinicalTrials.gov registry record · Phase 2
ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT02917629: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02917629 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02917629, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This randomized phase IIb trial studies how well ACTOplus met extended release (XR) works in treating in patients with stage I-IV oral cavity or oropharynx cancer that are undergoing definitive treatment. Chemoprevention is the use of drugs to keep oral cavity or oropharynx cancer from forming or coming back. The use of ACTOplus met XR may slow disease progression in patients with oral cavity or oropharynx cancer.
Primary Outcome
Baseline, post-exposure, absolute change in Ki-67, and difference in absolute change between the ACTOplus met XR and placebo subjects will all be summarized with descriptive statistics. Ki-67 is a semi-quantitative immune-histochemistry analysis in which a computer generates an analysis based on the staining within tumor and normal cells leading to a score which is an indirect measure of cellular proliferation. Will compare the difference in absolute change in Ki-67 between the ACTOplus met XR a
Interventions
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
- DRUG Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-05-31 |
| Est. Completion | 2019-08-28 |
| Phase | Phase 2 |
Why NCT02917629 stopped before completion
NCT02917629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02917629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02917629 about?
NCT02917629 is a clinical study titled "ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment". This randomized phase IIb trial studies how well ACTOplus met extended release (XR) works in treating in patients with stage I-IV oral cavity or oropharynx cancer that are undergoing definitive treatment. Chemoprevention is the use of drugs to keep oral cavity or oropharynx cancer from forming or co...
What is the current status of trial NCT02917629?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2018-05-31. Estimated completion is 2019-08-28.
What interventions are being tested in trial NCT02917629?
The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet (DRUG).
Who is sponsoring clinical trial NCT02917629?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02917629's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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