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Not Yet RecruitingNCT07467772

Ph 2 Elacestrant in ER Positive Uterine Sarcomas

A Phase 2 Study Evaluating the Efficacy of Elacestrant in Patients With Estrogen Receptor Positive Uterine Sarcomas

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Dana-Farber Cancer Institute · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

This study is to evaluate the efficacy and safety of elacestrant, in participants with advanced estrogen receptor (ER)-positive uterine sarcomas. The name of the study drug involved in this research study is: -Elacestrant (a type of selective estrogen receptor degrader)

Detailed description

This is a single-arm, open-label, phase 2 study evaluating the efficacy and safety of elacestrant in participants with advanced estrogen receptor (ER)-positive uterine sarcomas. Elacestrant is designed to block estrogen receptors, which may slow down or stop the growth of cancers that rely on estrogen to grow. The U.S. Food and Drug Administration (FDA) has not approved elacestrant as a treatment for ER positive uterine sarcoma. The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, and electrocardiograms (ECGs). It is expected that about 30 people will take part in this research study. Stemline-Menarini is supporting this research study by providing the study drug.

Conditions

Interventions

TypeNameDescription
DRUGElacestrantSelective estrogen receptor degrader, tablet taken orally per protocol.

Timeline

Start date
2026-02-01
Primary completion
2027-07-01
Completion
2028-04-01
First posted
2026-03-12
Last updated
2026-03-12

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07467772. Inclusion in this directory is not an endorsement.