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NCT01797523 · ClinicalTrials.gov record · last posted 2026-07-30

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

StatusCompleted
PhasePhase 2
Started2013-10-07
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from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-07-31
Trial completed
2026-07-31
Primary endpoint(s) modified
WasClinical Benefit Rate (CBR)
NowClinical Benefit (CBR) Complete Response + Partial Response + Stable Disease Rates) Based on RECIST v1.1.
2026-07-31
Primary completion moved earlier: 2027-10-31 → 2026-02-04
2026-07-31
Completion moved earlier: 2027-10-31 → 2026-02-04
Trial Details
NCT Number NCT01797523
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Novartis, National Cancer Institute (NCI)
Conditions Endometrial Cancer
Enrollment 62 participants
Start Date 2013-10-07
Primary Completion 2026-02-04 (estimated)
Study Completion 2026-02-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-30