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ACTIVE NOT RECRUITING
NCT01797523
PHASE2

A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

The goal of this clinical research study is to learn if the combination of everolimus, letrozole, and metformin can help to control recurrent or progressive endometrial cancer. The safety of this drug combination will also be studied. Everolimus is designed to block a protein inside cancer cells that is involved in cancer growth. Letrozole is designed to block a protein from making estrogen. This may interfere with the growth of cancer cells. Metformin is commonly used to control blood sugar levels in patients with diabetes. It is designed to lower insulin levels, which may slow or stop the growth of endometrial cancer cells.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2013-10-07

Completion Date

2027-10-31

Last Updated

2025-11-06

Healthy Volunteers

No

Interventions

DRUG

Metformin

500 mg by mouth daily for 4 days on Days 1 - 4 of Cycle 0 and then 2 times a day (about 12 hours apart) every day after that. Metformin taken for 7 - 10 days in Cycle 0 before Cycle 1 begins.

DRUG

Letrozole

2.5 mg tablet by mouth once daily in a 28 day cycle.

DRUG

Everolimus

10 mg by mouth once daily in a 28 day cycle.

Locations (6)

Sacred Heart Health Systems

Pensacola, Florida, United States

MD Anderson Cooper Cancer Center

Voorhees Township, New Jersey, United States

Memorial City Medical Center

Houston, Texas, United States

Lyndon B Johnson General Hospital

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

The Woman's Hospital of Texas

Houston, Texas, United States