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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

October 7, 2013

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Endometrial Cancer
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.

Trial Locations (6)

32504

Sacred Heart Health Systems, Pensacola

77024

Memorial City Medical Center, Houston

77026

Lyndon B Johnson General Hospital, Houston

77030

University of Texas MD Anderson Cancer Center, Houston

77054

The Woman's Hospital of Texas, Houston

08043

MD Anderson Cooper Cancer Center, Voorhees Township

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER