CompletedPhase 2

Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer

United States28 participantsStarted 2018-08-21

Plain-language summary

The purpose of this study is to determine the effectiveness of the combination of abemaciclib and fulvestrant in treating this type of cancer and to determine the types and severity of side effects caused by treatment with abemaciclib and fulvestrant.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Patients must have recurrent or persistent endometrial carcinoma that is refractory to curative therapy or established treatments.
✓. Histologic confirmation of the original primary tumor is required.
✓. Histologic or cytologic confirmation of the recurrent/progressive disease is desired, but not required.
✓. Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, de-differentiated, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma.
✓. Patient must have hormone receptor positive (HR+) endometrial cancer confirmed by MSK pathology:

Exclusion criteria

✕. Presence of measurable disease outside the CNS
✕. No radiographic evidence of worsening upon the completion of CNSdirected therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
✕. No history of intracranial hemorrhage or spinal cord hemorrhage
✕. No ongoing requirement for dexamethasone as therapy for CNS disease (anticonvulsants at a stable dose are allowed)
✕. Screening CNS radiographic study is ≤ 6 months after most recent intervention for CNS metastases (neurological resection, radiotherapy, or brain biopsy) and ≥ 4 months after the discontinuation of corticosteroids

What they're measuring

objective response rate

Timeframe: 1 year

Trial details

NCT IDNCT03643510

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-12

View on ClinicalTrials.gov More Adenocarcinoma of Endometrium trials