Ph 2 Elacestrant in ER Positive Uterine Sarcomas

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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)

Eligibility criteria

Qualifiers

True abstinence when this is in line with the preferred and usual lifestyle of the participant. [Periodic abstinence (e.g., calendar, ovulation, symptothermal post-ovulation methods) and withdrawal are not acceptable methods of contraception].

Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female participants, the vasectomized male partner should be the sole partner.

Condom with spermicidal foam/gel/film/cream/suppository.

Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Elacestrant

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Dana-Farber Cancer Institute

Lead sponsor

Stemline Therapeutics, Inc.

Collaborator