Everolimus + Letrozole +/- Ribociclib for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Pamela T. Soliman | MD Anderson Cancer ...

Overseen ByPamela T. Soliman

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new drug combination for advanced or recurrent endometrial cancer. It targets patients whose cancer has spread or returned. The treatment works by blocking enzymes needed for cancer cell growth and by stopping the cells from dividing or spreading. Anlotinib is a new drug that targets multiple aspects of cancer growth.

Eligibility Criteria

This trial is for patients with advanced or recurrent endometrial carcinoma who have had no more than two prior chemotherapy regimens and are not currently pregnant or breastfeeding. They must be able to provide informed consent, have a GOG performance status of 0 to 1, and meet specific blood count and organ function criteria. Prior radiation therapy and letrozole treatment are acceptable under certain conditions.

Inclusion Criteria

My kidney function, measured by eGFR, is adequate.

My disease cannot be cured with treatment and is getting worse.

My liver function tests are within the required range.

My kidney function is within the normal range.

I am fully active or restricted in physically strenuous activity but can do light work.

I have at least one tumor that can be measured and has not been previously treated with radiation.

I haven't taken any cancer treatments or immunologic agents for the last 4 weeks.

I have been diagnosed with a specific type of uterine cancer.

Exclusion Criteria

I haven't had major surgery or recovered from its major side effects within the last 14 days.

I am allergic to ribociclib, everolimus, or their ingredients.

I am not taking strong CYP3A4/5 drugs, certain supplements, hormone therapies, or warfarin.

I do not have serious heart problems or abnormal heart rhythms.

I have severe liver disease.

I have previously been treated with an mTOR inhibitor.

I do not have major stomach or bowel problems that could affect how I absorb medication.

My cancer is a specific type of uterine cancer.

I don't have Long QT syndrome, sudden death in family, or risk factors for Torsades de Pointe.

Participant Groups

The study is testing the effectiveness of everolimus combined with letrozole, with or without ribociclib, in treating endometrial cancer that has spread or returned. Ribociclib blocks enzymes needed for cell growth while everolimus and letrozole work by killing cells, stopping division, or preventing spread.

2Treatment groups

Experimental Treatment

Group I: Arm II (everolimus, letrozole)Experimental Treatment2 Interventions

Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (ribociclib, everolimus, letrozole)Experimental Treatment3 Interventions

Patients receive ribociclib PO QD, everolimus PO QD, and letrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

🇺🇸 Approved in United States as Afinitor for: