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NCT01442870 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy
A Phase 1 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
NCT01442870: Completed Phase 1 study, sponsored by Tufts Medical Center.
NCT01442870 is a Phase 1 study that has completed, run by Tufts Medical Center. The registered enrollment target is 105 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01442870, a Phase 1 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
Study Summary
Metformin is a drug that is normally used to treat people with diabetes. New research has discovered that metformin may also kill cancer stem cells. These cancer stem cells make up only a small portion of a cancer, but may be responsible for resistance to chemotherapy or for causing recurrence of the cancer. Future studies are envisioned to that test the efficacy of administering metformin with chemotherapy. The purpose of this study is to assess the safety of administering metformin in combination with chemotherapy. Since chemotherapy and cancer itself both cause adverse events by themselves, this study is designed to have a run-in stage as well as a subsequent randomization to metformin or no metformin. The primary endpoint will compare the rate of dose-limiting toxicities between these two arms. After a period of 3 weeks for the primary endpoint comparison, all patients will receive metformin.
Primary Outcome
The primary endpoint of the study will be to determine whether metformin can be safely added to a chemotherapy regimen that is previously well tolerated. The rate of dose limiting toxicities will be compared.
Interventions
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01442870 record still lists
NCT01442870 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher).
The record links to 0 conditions, and to 1 intervention - of which Metformin is the first listed.
NCT01442870 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01442870 about?
NCT01442870 is a clinical study titled "Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy". Metformin is a drug that is normally used to treat people with diabetes. New research has discovered that metformin may also kill cancer stem cells. These cancer stem cells make up only a small portion of a cancer, but may be responsible for resistance to chemotherapy or for causing recurrence of th...
What is the current status of trial NCT01442870?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2011-09. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01442870?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT01442870?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01442870's enrollment target sits among peer trials
105 533rd of 2000 higher than 1,465 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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