Phase 2 Study of Elacestrant for Treating Estrogen Receptor Positive Uterine Sarcomas

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT07467772

Provider View

This clinical trial is testing the safety and effectiveness of a drug called elacestrant in treating advanced uterine sarcomas that are positive for estrogen receptors. Elacestrant works by blocking estrogen receptors, which may help slow or stop the growth of these cancers.

Patient Parameters

Program Overview

The study aims to evaluate how well elacestrant works and how safe it is for patients with advanced uterine sarcomas that have estrogen receptors. Elacestrant is a drug that targets and blocks estrogen receptors, potentially slowing down or stopping the growth of cancers that rely on estrogen. The study involves various procedures, including medical tests and scans, to monitor the participants' health and the drug's effects. Approximately 30 participants will be involved in this study, which is supported by Stemline-Menarini.

Description

This study is open to patients with advanced uterine sarcomas that are positive for estrogen receptors. Elacestrant, the study drug, is not yet approved by the FDA for this type of cancer. Participants will undergo several procedures, including blood and urine tests, imaging scans like CT or MRI, and heart monitoring through ECGs. The study will involve about 30 participants, and the drug is provided by Stemline-Menarini. Participants will be closely monitored for any side effects and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of specific types of uterine sarcoma, such as uterine leiomyosarcoma or endometrial stromal sarcoma.
  • Tumor must show strong estrogen receptor presence in most cells.
  • Cancer must be advanced or spread and not treatable with surgery.
  • Must have measurable tumors that can be tracked with scans.
  • Must be 18 years or older.
  • Must be in good health with adequate organ function.
  • Must not have had other invasive cancers in the past 5 years, except for certain skin or cervical cancers.
  • Must have completed any previous cancer treatments and recovered from side effects.
  • Must be able to swallow pills and willing to follow study procedures.
  • Women of childbearing age must use effective contraception during and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot be taking other experimental drugs.
  • Cannot have allergies to similar drugs as elacestrant.
  • Cannot have rapidly worsening cancer that poses immediate health risks.
  • Cannot have uncontrolled health issues like infections or heart disease.
  • Cannot have psychiatric or social issues that prevent following the study.
  • Cannot be taking certain medications that interact with the study drug.
  • Cannot be pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute02215BostonMassachusetts

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