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NCT03076281 · ClinicalTrials.gov registry record · Phase 2
Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03076281: Clinical Trial Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT03076281 is a Phase 2 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 7 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
NCT03076281, a Phase 2 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well metformin hydrochloride and doxycycline work in treating patients with head and neck squamous cell carcinoma that can be removed by surgery. Metformin hydrochloride may reduce the metabolic activity of cancer cells and of surrounding supportive tissue. Doxycycline may minimize toxic side effects of anti-cancer therapy. Giving metformin hydrochloride and doxycycline may work better in treating patients with head and neck squamous cell carcinoma.
Primary Outcome
Within-patient change in IHC scores will be analyzed using the Wilcoxon signed-rank test. Comparisons will be made between pretreatment and post-treatment within each of the cohorts. Caveolin-1 (CAV1) immunohistochemistry (IHC) will be performed on pre- and post-treatment tumor specimens. The mean percentage of fibroblasts expressing CAV1 will be compared before and after treatment.
Interventions
- DRUG Metformin Hydrochloride
- DRUG Doxycycline
- DRUG Metformin +Doxycycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2017-04-03 |
| Est. Completion | 2018-12-03 |
| Phase | Phase 2 |
Why NCT03076281 stopped before completion
NCT03076281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 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 3 interventions - of which Metformin Hydrochloride is the first listed.
NCT03076281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03076281 about?
NCT03076281 is a clinical study titled "Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma". This randomized phase II trial studies how well metformin hydrochloride and doxycycline work in treating patients with head and neck squamous cell carcinoma that can be removed by surgery. Metformin hydrochloride may reduce the metabolic activity of cancer cells and of surrounding supportive tissue....
What is the current status of trial NCT03076281?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2017-04-03. Estimated completion is 2018-12-03.
What interventions are being tested in trial NCT03076281?
The interventions under investigation include: Metformin Hydrochloride (DRUG), Doxycycline (DRUG), Metformin +Doxycycline (DRUG).
Who is sponsoring clinical trial NCT03076281?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03076281's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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