Abemaciclib + Fulvestrant for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byAngela Green, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for women over 18 with recurrent endometrial cancer who've had a hysterectomy and/or oophorectomy, are postmenopausal, and may have had limited prior treatments. They should be in good health otherwise, not pregnant or breastfeeding, willing to use contraception if of childbearing potential, and able to swallow pills.

Inclusion Criteria

I have had both of my ovaries surgically removed.

Agreement to pre- and post-treatment tumor biopsies

Disease that is measurable as per RECIST v1.1

+33 more

Exclusion Criteria

I have been treated with specific cancer drugs like fulvestrant or CDK4/6 inhibitors.

I am HIV positive.

Serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study

+19 more

Participant Groups

The study tests the effectiveness of combining two drugs: Abemaciclib and Fulvestrant in treating recurrent endometrial cancer. It also examines the side effects of this treatment combination on participants.

1Treatment groups

Experimental Treatment

Group I: Fulvestrant in Combination with AbemaciclibExperimental Treatment2 Interventions

Eligible patients will take Abemaciclib 150 milligrams mg orally once every 12 hours on days 1-28. Fulvestrant will be dosed 500mg intramuscularly (IM) on days 1 and 15 during cycle 1 and then on Day 1 during subsequent cycles. Each cycle will be 28 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, or study termination.

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Verzenio for:

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for: