NCT01442870

Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy

Prospective Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Metformin	Metformin

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-02-01
• Completion: 2014-11-01
• First posted: 2011-09-29
• Last updated: 2017-05-09

Locations

1 site across 1 country: United States