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Cyclin-Dependent Kinase Inhibitor

Abemaciclib + Fulvestrant for Endometrial Cancer

Phase 2

Waitlist Available

Led By Angela Green, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior bilateral oophorectomy

History of hysterectomy

Must not have

Received prior treatment with fulvestrant, everolimus, temsirolimus, ridaforolimus or another mTor inhibitor, or any CDK4 and CDK6 inhibitor

Known HIV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug combo to see if it's more effective than current treatments for this type of cancer, and what kind of side effects it causes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, common ones from similar treatments include nausea, fatigue, risk of infection due to low blood cell counts, hot flashes from hormonal therapy like fulvestrant and possible liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had both of my ovaries surgically removed.

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I have had a hysterectomy.

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I have received chemotherapy with radiation to enhance its effect.

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I am 18 years old or older.

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My endometrial cancer has come back or hasn't responded to treatment.

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My endometrial cancer is mostly made up of endometrioid cells.

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I have fully recovered from radiotherapy and it has been at least 14 days since my last session.

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My cancer is one of the specified types of epithelial cell cancer.

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I am fully active or able to carry out light work, with a high level of self-care.

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I am very active and can carry out all my daily activities without help.

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I am 60 years old or older.

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I am postmenopausal due to surgery or naturally.

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My endometrial cancer is hormone receptor positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am HIV positive.

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I have a significant history of liver problems or currently abuse alcohol.

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My autoimmune disease isn't controlled by basic anti-inflammatory medication.

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I have not had a heart attack or severe heart issues in the last 6 months.

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I have moderate to severe heart failure.

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I have a condition that affects how my body absorbs food.

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My cancer has spread to my internal organs, causing a crisis.

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I have had a stem-cell transplant.

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I do not have any severe illnesses that are not under control.

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I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.

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My cancer has spread to the lining of my brain and spinal cord.

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I have untreated brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

objective response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3790

Abemaciclib

2019

Completed Phase 2

~1890