Actively Recruiting
Ph 2 Elacestrant in ER Positive Uterine Sarcomas
Led by Dana-Farber Cancer Institute · Updated on 2026-04-21
30
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
S
Stemline Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Ph 2 Elacestrant in ER Positive Uterine Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Histologically confirmed uterine sarcoma subtype: uterine leiomyosarcoma, endometrial stromal sarcoma, uterine adenosarcoma, or uterine PEComa
- Tumor with moderate to strong estrogen receptor expression (≥75% of tumor cells)
- Locally advanced or metastatic disease not suitable for surgery
- Measurable disease with lesions ≥20 mm by chest x-ray or ≥10 mm by CT, MRI, or clinical exam
- ECOG performance status 0, 1, or 2
- Adequate organ and marrow function including specified levels for hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, and kidney function
- HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months
- Participants with chronic hepatitis B or treated hepatitis C with undetectable viral load
- Treated brain metastases with no progression on follow-up imaging
- Disease-free from prior invasive cancers for over 5 years except certain skin or cervical cancers
- Completed prior chemotherapy or radiotherapy at least 2 weeks before study entry (6 weeks for certain drugs)
- Recovered from prior treatment side effects except alopecia
- Cardiac function assessed as New York Heart Association Class 2B or better
- QTc interval below 450 msec
- Ability to comply with study procedures and swallow pills
- Willingness and ability to sign informed consent
- Use of adequate contraception during and for 6 months after treatment if of childbearing potential
- Postmenopausal status or use of GnRH agonists as specified
You will not qualify if you...
- Receiving any other investigational agents
- Allergic reactions to elacestrant or similar compounds
- Rapidly progressive symptomatic disease with risk of life-threatening complications
- Uncontrolled illnesses including infection, diabetes, heart disease, or hypertension
- Psychiatric or social conditions limiting study compliance
- Treatment with strong CYP3A inducers or inhibitors within 2 weeks before study treatment that cannot be replaced
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
S
Suzanne George, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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