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mTOR inhibitor
Everolimus + Letrozole + Metformin for Endometrial Cancer
Phase 2
Waitlist Available
Led By Pamela Soliman, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate bone marrow function as shown by: ANC >/= 1.5 x 10^9/L, Platelets >/= 100 x 10^9/L, Hb >9 g/dL
Patients must have histologically-confirmed advanced or recurrent endometrial carcinoma (endometrioid and mixed tumors, any grade) that is refractory to curative therapy or established treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test if everolimus, letrozole, and metformin can help control endometrial cancer that has come back or is progressing. Researchers will also study if the combination is safe.
Who is the study for?
This trial is for adults with advanced or recurrent endometrial carcinoma that's resistant to standard treatments. Participants can have had no more than two prior chemo regimens, must not be pregnant or of child-bearing potential, and should have adequate organ function. They cannot join if they've had other cancers (except certain skin cancers) in the past 3 years, known hypersensitivity to everolimus, uncontrolled brain metastases, severe liver impairment, active infections, or are on immunosuppressants.Check my eligibility
What is being tested?
The study tests a combination of three drugs: Everolimus (blocks cancer growth proteins), Letrozole (interferes with estrogen production affecting cancer cell growth), and Metformin (commonly used for diabetes but may slow cancer by lowering insulin levels). The aim is to see if this combo controls endometrial cancer better and understand its safety profile.See study design
What are the potential side effects?
Potential side effects include blood sugar changes due to Metformin; fatigue; increased risk of infection; hormonal changes from Letrozole; and possible organ inflammation from Everolimus. Each drug has its own set of risks which will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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My endometrial cancer is advanced, has returned, and doesn't respond to standard treatments.
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I am 18 years old or older.
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I haven't taken any cancer treatments, including immunotherapy or hormone therapy, for the last 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Benefit Rate (CBR)
Secondary outcome measures
Progression-Free Survival (PFS)
Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Letrozole + Metformin + RAD001Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Metformin
2006
Completed Phase 4
~2430
Letrozole
2002
Completed Phase 4
~3240
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,605 Total Patients Enrolled
74 Trials studying Endometrial Cancer
73,312 Patients Enrolled for Endometrial Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,740 Total Patients Enrolled
21 Trials studying Endometrial Cancer
5,392 Patients Enrolled for Endometrial Cancer
NovartisIndustry Sponsor
1,610 Previous Clinical Trials
2,719,208 Total Patients Enrolled
3 Trials studying Endometrial Cancer
52 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to everolimus or similar medications.My cancer has returned in a specific area and can be treated with surgery or radiation.I have a condition like metabolic acidosis and take metformin.I have had 2 or fewer chemotherapy treatments for recurrent endometrial cancer.I am willing and able to follow the study's requirements.I haven't had major surgery or significant injury in the last 4 weeks and don't expect to need major surgery soon.I am on long-term steroids or other drugs that weaken my immune system, but I can use creams or inhalers.I am not pregnant or breastfeeding and use effective birth control.I cannot become pregnant because I am surgically sterile or have been menopausal for over a year.I have a tumor that can be measured and has not been previously treated with radiation.My blood tests show normal white blood cells, platelets, and hemoglobin levels.I do not have severe liver disease, HIV, major gut issues that affect drug absorption, or a bleeding disorder.I haven't had any cancer except skin cancer in the last 3 years.I do not have uncontrolled brain cancer or need steroids for brain cancer.I have been treated with an mTOR inhibitor before.My endometrial cancer is advanced, has returned, and doesn't respond to standard treatments.I haven't had any live vaccines in the last week and will avoid them during the study.I have been treated with letrozole before.I am 18 years old or older.I haven't taken any cancer treatments, including immunotherapy or hormone therapy, for the last 4 weeks.I haven't had any cancer treatments in the last 4 weeks.I have had radiation therapy before.My cancer is a specific type of uterine cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Letrozole + Metformin + RAD001
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you tell me what conditions are typically helped by Metformin?
"Metformin is most often used to manage waldenstrom macroglobulinemia, but it can also be useful for treating side effects from tamoxifen, lung, and advanced carcinoid tumors."
Answered by AI
Can you please share what other research studies have included Metformin?
"Metformin was first trialed in 1995 at the National Institutes of Health Clinical Center. As of now, there have been a total of 1673 completed studies. However, there are still 430 active clinical trials, many of which are based in Voorhees, New jersey."
Answered by AI
Is this study looking for more participants?
"This trial, as indicated by clinicaltrials.gov, is not currently looking for patients. The trial was first posted on October 7th, 2013 and was edited most recently on August 18th, 2022. However, there are nearly 3200 other trials that are presently recruiting candidates."
Answered by AI
Has the FDA greenlit Metformin for public consumption?
"While there is data supporting Metformin's safety, there is currently none to suggest that it is an effective treatment. Therefore, it received a score of 2."
Answered by AI
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