Elacestrant + Everolimus for Endometrial Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial tests how well elacestrant with everolimus works for the treatment of estrogen receptor (ER) positive endometrial cancer that has come back after a period of improvement (recurrent), that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Estrogen can cause the growth of cancer cells. Elacestrant lowers the amount of estrogen made by the body. This may help stop the growth of cancer cells that need estrogen to grow. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping cancer cells from reproducing and by decreasing blood supply to the cancer cells. Giving elacestrant with everolimus may be effective for treating patients with recurrent, advanced or metastatic ER positive endometrial cancer.
Who Is on the Research Team?
Jordyn Silverstein, MD
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with estrogen receptor (ER) positive endometrial (uterine) cancer that has come back, spread nearby, or to other parts of the body. Participants should have advanced or metastatic disease and be able to undergo study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive elacestrant and everolimus orally once daily on days 1-28 of each 28-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Elacestrant
- Everolimus
Trial Overview
The study is testing a combination of two drugs—elacestrant and everolimus—to see if they work together against ER-positive endometrial cancer that has returned or spread. Imaging scans and questionnaires are also part of the research.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive elacestrant PO QD and everolimus PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan with or without PET scan or MRI and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
Stemline Therapeutics, Inc.
Industry Sponsor
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