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Aromatase inhibitor

Everolimus + Letrozole for Endometrial Cancer

Phase 2
Waitlist Available
Led By Pamela T. 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
Patients must have adequate hepatic function
Baseline lipid levels (triglycerides, cholesterol) must be </= grade 1
Must not have
Patients who have previously received RAD001 or another mTOR inhibitor or letrozole or another aromatase inhibitor
Patients who have uterine sarcomas or mixed malignant mullerian tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 8 weeks of treatment, then every 12 weeks, up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a combination of everolimus and letrozole can help control endometrial cancer that has come back or is progressing. The safety of this drug combination will also be studied.

Who is the study for?
This trial is for adults with advanced or recurrent endometrial cancer that has progressed. Participants must have tried fewer than two chemotherapy regimens, not be pregnant, and have no severe concurrent diseases. They should not have used certain cancer treatments recently and must not be of childbearing potential.
What is being tested?
The study tests the effectiveness and safety of combining RAD001 (Everolimus) with Letrozole in controlling recurrent or progressive endometrial cancer. It aims to find out if this drug combination can help patients whose disease has returned or worsened after treatment.
What are the potential side effects?
Possible side effects include immune system suppression leading to increased infection risk, hormonal changes, blood lipid alterations, digestive issues, and potential allergic reactions to the drugs' components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is working well.
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My cholesterol and triglyceride levels are within normal limits.
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My kidneys work well, with a function over 50cc/min.
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I am 18 years old or older.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My endometrial cancer has come back or is getting worse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously taken RAD001, mTOR inhibitors, letrozole, or aromatase inhibitors.
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I have uterine sarcoma or a mixed malignant mullerian tumor.
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My cancer recurrence can potentially be cured with surgery or radiation.
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I do not have severe liver, kidney, or digestive diseases.
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My ovaries are functioning normally.
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I have a known history of heart disease.
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I have a history of severe lung problems.
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I have untreated brain metastases.
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I have cancer cells in the fluid around my brain and spinal cord.
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I am allergic to everolimus or similar medications.
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I am not currently on chemotherapy or radiotherapy and haven't been for the last 4 weeks.
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I am on long-term steroids or other drugs that affect my immune system.
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I am currently taking antibiotics for an active infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 8 weeks of treatment, then every 12 weeks, up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 8 weeks of treatment, then every 12 weeks, up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Objective Response Rate
Secondary study objectives
Median Overall Survival (OS)
Median Progression Free Survival (PFS)
Number of Participants With Adverse Events (All Grades)

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538
10%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole

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 + RAD001Experimental Treatment2 Interventions
Letrozole and RAD001 (Everolimus)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RAD001 (Everolimus)
2010
Completed Phase 2
~80
Letrozole
2002
Completed Phase 4
~3590

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,261 Total Patients Enrolled
3 Trials studying Endometrial Cancer
72 Patients Enrolled for Endometrial Cancer
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,305 Total Patients Enrolled
22 Trials studying Endometrial Cancer
6,219 Patients Enrolled for Endometrial Cancer
Pamela T. Soliman, MDPrincipal InvestigatorM.D. Anderson Cancer Center
~8 spots leftby Apr 2028
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