Abemaciclib + Letrozole for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Gynecologic Oncology Group

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a phase II single arm trial to determine the percentage of patients without evidence of disease progression on abemaciclib and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer at 6 months. Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.

Eligibility Criteria

This trial is for adults with advanced, persistent, or recurrent endometrioid endometrial cancer that can't be cured by surgery or radiotherapy. Participants must have measurable disease, no more than two prior systemic therapies (only one may include chemo), and good organ function. They cannot join if they've had CDK4/6 inhibitors before, other cancer types like clear cell or serous cancers, known allergies to the drugs being tested, active infections, CNS metastases, HIV infection, certain medical conditions affecting drug absorption or bleeding risk.

Inclusion Criteria

I've had chemotherapy for early-stage cancer or for a pelvic recurrence.

My cancer's MMR, MSI, and hormone receptor status have been tested and reported if available.

My cancer is endometrioid type, confirmed by surgery or biopsy.

+24 more

Exclusion Criteria

I have taken medication that targets CDK4/6 for my cancer.

My cancer has spread to my brain.

I do not have any ongoing serious infections.

+14 more

Participant Groups

The trial tests how well patients with specific endometrial cancer respond to a combination of Abemaciclib and Letrozole after six months without their disease getting worse. It's a phase II study where all participants receive the same treatment until it's not tolerated anymore or until the disease progresses.

1Treatment groups

Experimental Treatment

Group I: Abemaciclib and LetrozoleExperimental Treatment2 Interventions

Study treatment will consist of abemaciclib 150mg orally twice a day and letrozole 2.5mg orally once a day.

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: