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)
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.
None
Single group
Elacestrant
DrugSelective estrogen receptor degrader, tablet taken orally per protocol.
Objective Response Rate (ORR)
ORR is defined as proportion of participants achieving partial response (PR) or better on treatment per the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 (Eisenhauer et al. Eur J Ca 2009; section 11.0).
Treatment-Related Grade 3-4 Adverse Event (AE) Rate
Percentage of participants who experience an AE of grade 3 or 4 with treatment attribution of possible, probable or definite per Common Toxicity Adverse Event Criteria (CTCAE) version 5 on treatment.
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Dana-Farber Cancer Institute
Lead sponsor
Stemline Therapeutics, Inc.
Collaborator
