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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

Must not have

Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: a. Symptomatic congestive heart failure of New York heart Association Class III or IV; b. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease; c. Severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air; d. Active (acute or chronic) or uncontrolled severe infections

Patients with a known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus, temsirolimus) or to its excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to everolimus or similar medications.

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My cancer has returned in a specific area and can be treated with surgery or radiation.

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I am not pregnant or breastfeeding and use effective birth control.

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I haven't had any cancer except skin cancer in the last 3 years.

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I do not have uncontrolled brain cancer or need steroids for brain cancer.

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I have been treated with an mTOR inhibitor before.

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I haven't had any cancer treatments in the last 4 weeks.

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My cancer is a specific type of uterine cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Benefit Rate (CBR)

Secondary study objectives

Progression-Free Survival (PFS)

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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