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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 is a Phase 1 study that has completed, run by Tufts Medical Center. The registered enrollment target is 105 participants.
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.
Interventions
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01442870
The ClinicalTrials.gov registry entry for NCT01442870 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Metformin is the first listed.
NCT01442870 reports 0 study locations.
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.
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