Everolimus + Letrozole +/- Ribociclib for Endometrial Cancer

Recruiting at 1 trial location

Overseen By Pamela T Soliman

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: CYP3A4/5 inducers/inhibitors, Warfarin

Disqualifiers: Uterine sarcomas, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 28 days per cycle, repeated until disease progression or unacceptable toxicity

90 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Pamela T. Soliman

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Your platelet count should be at least 100 billion per liter at the screening.

Exclusion Criteria

I haven't had cancer in the last 3 years, except for certain skin cancers or treated cervical cancer.

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

I haven't had any cancer treatments in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ribociclib, everolimus, and letrozole or everolimus and letrozole alone on a 28-day cycle

28 days per cycle, repeated until disease progression or unacceptable toxicity

Daily oral administration

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

30 days initially, then every 3 months

1 visit at 30 days, then quarterly visits

What Are the Treatments Tested in This Trial?

Interventions

• Everolimus
• Letrozole
• Ribociclib

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm II (everolimus, letrozole) Experimental Treatment 2 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 Treatment 3 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 for the following indications:

Approved in United States as Afinitor for:

• Advanced renal cell carcinoma
• Subependymal giant cell astrocytoma
• Progressive neuroendocrine tumors of pancreatic origin
• Advanced hormone receptor-positive, HER2-negative breast cancer
• Tuberous sclerosis complex-associated partial-onset seizures

Approved in European Union as Votubia for:

• Subependymal giant cell astrocytoma
• Renal angiomyolipoma
• Tuberous sclerosis complex-associated partial-onset seizures

Approved in United States as Zortress for:

• Prevention of organ rejection in kidney transplant patients

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+