Study on Abemaciclib and Fulvestrant for Treating Recurrent Endometrial Cancer in Women

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03643510

This clinical trial is testing the effectiveness and safety of combining two drugs, abemaciclib and fulvestrant, to treat women with endometrial cancer that has returned after previous treatments.

Patient Parameters

Program Overview

The aim of this study is to find out how well the combination of abemaciclib and fulvestrant works in treating recurrent endometrial cancer and to understand the side effects that may occur with this treatment.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Good overall health with specific performance status scores.
  • May have had up to two previous chemotherapy treatments for endometrial cancer.
  • May have had one previous hormonal therapy.
  • Must have recovered from any recent surgery, radiation, or chemotherapy side effects.
  • Must be postmenopausal, either naturally or through surgery.
  • Must have a negative pregnancy test and agree to use effective birth control during the study and for one month after.
  • Must agree to provide tumor samples before and after treatment.
  • Must have measurable cancer according to specific criteria.
  • No active infections requiring antibiotics.
  • Must have recurrent or persistent endometrial cancer that hasn't responded to other treatments.
  • Must have specific types of endometrial cancer confirmed by tests.
  • Must have hormone receptor positive (HR+) endometrial cancer.
  • Must have adequate blood counts and organ function based on lab tests.
  • Must be able to swallow pills and willing to follow study procedures.

Exclusion Criteria

  • Have participated in another clinical trial within the last 30 days.
  • Have severe organ dysfunction or rapidly progressing disease.
  • Have previously been treated with certain cancer drugs.
  • Have had a stem-cell transplant.
  • Have significant liver disease or current alcohol abuse.
  • Have active infections or positive tests for hepatitis B, hepatitis C, or HIV.
  • Have uncontrolled autoimmune diseases.
  • Are pregnant or breastfeeding.
  • Have severe, uncontrolled medical conditions.
  • Have had major surgery recently or need major surgery during the study.
  • Have certain electrolyte imbalances.
  • Have untreated or active brain metastases.
  • Have conditions that prevent swallowing pills or absorbing medication.
  • Have a history of serious heart conditions or other medical issues that could interfere with the study.

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