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NCT01816659 · ClinicalTrials.gov registry record · Phase 1
An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01816659: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01816659 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01816659, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn more about the possible effects of metformin extended release (ER) in patients with colon cancer or adenomas who are about to have surgery. The safety of this drug will also be studied. Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is also designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease.
Primary Outcome
Primary outcome measure is change in the percentage of Ki67-positive-staining cells between the baseline colonoscopy and surgery in the colon rectal cancer/non-resectable adenoma samples.
Interventions
- DRUG Metformin ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
Why NCT01816659 stopped before completion
NCT01816659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Metformin ER is the first listed.
NCT01816659 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01816659 about?
NCT01816659 is a clinical study titled "An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin". The goal of this clinical research study is to learn more about the possible effects of metformin extended release (ER) in patients with colon cancer or adenomas who are about to have surgery. The safety of this drug will also be studied. Metformin-ER is commonly used to control blood sugar levels ...
What is the current status of trial NCT01816659?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2013-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01816659?
The interventions under investigation include: Metformin ER (DRUG).
Who is sponsoring clinical trial NCT01816659?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01816659's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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