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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 8 weeks of treatment, then every 12 weeks, up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Objective Response Rate
Secondary outcome measures
Median Overall Survival (OS)
Median Progression Free Survival (PFS)
Number of Participants With Adverse Events (All Grades)
+1 more

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

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
~3240

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,720,993 Total Patients Enrolled
3 Trials studying Endometrial Cancer
72 Patients Enrolled for Endometrial Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,432 Total Patients Enrolled
21 Trials studying Endometrial Cancer
5,412 Patients Enrolled for Endometrial Cancer
Pamela T. Soliman, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Letrozole and RAD001 With Advanced or Recurrent Endometrial Cancer
2010. "Letrozole and RAD001 With Advanced or Recurrent Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01068249.
All > Endometrial Cancer
~9 spots leftby Apr 2028
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