Metformin + LR-IUD for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byVictoria Bae-Jump, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

Purpose: This is an open label, single-arm, single-center study of the addition of metformin to standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment of 30 evaluable non-surgical patients with either complex atypical hyperplasia (CAH; n=15) or grade 1 endometrial adenocarcinoma (EC; n=15). Participants:Women, over the age of 18 years, with biopsy-proven CAH/EC who are not candidates for surgical management, and therefore are planned to start standard of care treatment with the LR-IUD Procedures (methods): subjects will be given oral metformin therapy for 12 months, or until disease progression occurs (whichever occurs first), in addition to LR-IUD treatment. Serial endometrial biopsies will be performed, as per standard of care, to assess disease status.

Eligibility Criteria

This trial is for women over 18 with complex atypical hyperplasia or grade 1 endometrial cancer who can't have surgery due to high risk or desire to preserve fertility. They must be able to start treatment with a levonorgestrel-releasing intrauterine device and not have used metformin recently, nor should they have significant kidney, liver issues, or certain infections.

Inclusion Criteria

I am considered a high risk for surgery due to my health status.

I am a woman who can have children and have a negative pregnancy test.

My condition is either complex atypical hyperplasia or grade 1 endometrial cancer.

See 6 more

Exclusion Criteria

Recent (< 4 weeks) active, documented, cervical infection

I have not been exposed to iodinated contrast agents in the last 48 hours.

My cancer has a mix of certain cell types.

See 7 more

Treatment Details

Interventions

Metformin (Anti-diabetic drug)

Trial OverviewThe study tests the addition of oral metformin therapy for up to 12 months alongside standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment in non-surgical patients. It aims to evaluate the effectiveness of this combination in treating CAH and EC by monitoring disease progression through regular biopsies.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: MetforminExperimental Treatment1 Intervention

Metformin, 850 mg. twice daily.

Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Glucophage for: