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NCT01849276 · ClinicalTrials.gov registry record · Phase 1
Metformin+Cytarabine for the Treatment of Relapsed/Refractory AML
A Phase 1 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01849276: Clinical Trial Phase 1 study, sponsored by Northwestern University.
NCT01849276 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01849276, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of the study is to determine if metformin in combination with cytarabine is safe and effective. Participants in this research study have acute myeloid leukemia (AML) that has come back after initial treatment or has not gone away with initial therapy.There is evidence that metformin directly kills leukemia cells. Laboratory data have also shown that combinations of metformin with cytarabine are more efficient than each agent alone in killing leukemia cells in the laboratory.
Primary Outcome
To determine the maximum tolerated dose (MTD) by assessing the adverse events of metformin in combination with cytarabine in evaluating toxicity. Assessments will occur daily during cytarabine administration and at least twice weekly following treatment until blood count recovery.
Interventions
- OTHER laboratory biomarker analysis
- DRUG metformin hydrochloride
- DRUG cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-03-11 |
| Est. Completion | 2016-01-21 |
| Phase | Phase 1 |
Why NCT01849276 stopped before completion
NCT01849276 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01849276 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01849276 about?
NCT01849276 is a clinical study titled "Metformin+Cytarabine for the Treatment of Relapsed/Refractory AML". The purpose of the study is to determine if metformin in combination with cytarabine is safe and effective. Participants in this research study have acute myeloid leukemia (AML) that has come back after initial treatment or has not gone away with initial therapy.There is evidence that metformin dire...
What is the current status of trial NCT01849276?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2015-03-11. Estimated completion is 2016-01-21.
What interventions are being tested in trial NCT01849276?
The interventions under investigation include: laboratory biomarker analysis (OTHER), metformin hydrochloride (DRUG), cytarabine (DRUG).
Who is sponsoring clinical trial NCT01849276?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01849276's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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