A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma
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|ClinicalTrials.gov Identifier: NCT01797523|
Recruitment Status : Active, not recruiting
First Posted : February 22, 2013
Last Update Posted : January 27, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Metformin Drug: Letrozole Drug: Everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma|
|Actual Study Start Date :||October 7, 2013|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Letrozole + Metformin + RAD001
Patients have a 7-10 day lead in period where they take Metformin alone. The starting dose of Metformin 500 mg by mouth daily for 4 days and then increased to 500 mg by mouth twice a day. Everolimus and Letrozole added and considered the start of Cycle #1.
Everolimus administered by mouth as once daily dose of 10 mg. Letrozole 2.5 mg tablet by mouth once daily. The oral dose of Everolimus should be taken together with the daily dose of Letrozole 2.5mg.
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.
2.5 mg tablet by mouth once daily in a 28 day cycle.
Other Name: Femara
10 mg by mouth once daily in a 28 day cycle.
- Clinical Benefit Rate (CBR) [ Time Frame: 8 weeks ]Clinical benefit rate (CBR) determined by combining the complete response rate, partial response rate, and stable disease rate. Response evaluated by repeat imaging (CT or MRI) using RECIST 1.1 at the completion of the second cycle (8 weeks + 7 days of treatment).
- Progression-Free Survival (PFS) [ Time Frame: 6 months ]Survival determined by measuring the time from study entry (1st treatment) to progression (PFS) or death (OS). Progression-free survival (PFS) and overall survival (OS) estimated with the Kaplan-Meier product-limit estimator.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797523
|United States, Florida|
|Sacred Heart Health Systems|
|Pensacola, Florida, United States, 32504|
|United States, New Jersey|
|MD Anderson Cooper Cancer Center|
|Voorhees, New Jersey, United States, 08043|
|United States, Texas|
|Memorial City Medical Center|
|Houston, Texas, United States, 77024|
|Lyndon B Johnson General Hospital|
|Houston, Texas, United States, 77026|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|The Woman's Hospital of Texas|
|Houston, Texas, United States, 77054|
|Principal Investigator:||Pamela Soliman, MD||M.D. Anderson Cancer Center|