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NCT02325401 · ClinicalTrials.gov registry record · Phase 1
Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 1 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02325401: Completed Phase 1 study, sponsored by University of Cincinnati.
NCT02325401 is a Phase 1 study that has completed, run by University of Cincinnati. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02325401, a Phase 1 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this research study is to test the safety of adding metformin to standard of care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments and radiation for 7 weeks. Metformin is a medication that is currently used to treat diabetes. Increasing amounts of metformin will be given to groups of patients already receiving normal treatment for their cancer to see if metformin causes any good effects by killing your cancer or bad effects (side effects).
Primary Outcome
Cohorts of patients received escalating doses of metformin (2000 mg, 2550 mg, or 3000 mg divided into daily doses) with a 7-day to 14-day lead-in prior to CRT based on the modified toxicity probability interval design to allow for possible re-escalation after previous de-escalation and to maximize the ability to identify the maximum tolerated dose (MTD). Patients continued to receive metformin for the duration of CRT as tolerated.
Interventions
- DRUG Cisplatin
- RADIATION Radiation Therapy
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-05-11 |
| Est. Completion | 2020-02-21 |
| Phase | Phase 1 |
What the finished NCT02325401 record still lists
NCT02325401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT02325401 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02325401 about?
NCT02325401 is a clinical study titled "Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma". The purpose of this research study is to test the safety of adding metformin to standard of care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments and radiation for 7 weeks. Metformin is a medication that is currently used to treat diabetes. Increasing amounts of...
What is the current status of trial NCT02325401?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2015-05-11. Estimated completion is 2020-02-21.
What interventions are being tested in trial NCT02325401?
The interventions under investigation include: Cisplatin (DRUG), Radiation Therapy (RADIATION), Metformin (DRUG).
Who is sponsoring clinical trial NCT02325401?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02325401's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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