Abemaciclib + Letrozole +/- Metformin for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byPanagiotis Konstantininopoulos, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This research study is studying a combination of targeted therapies as a possible treatment for estrogen-receptor positive (ER+) endometrial cancer and low-grade serous ovarian cancer. The drugs involved in this study are: * Abemaciclib (also known as Verzenio™) * Letrozole (also known as Femara®) * Metformin (also known as Glucophage®) * Zotatifin (also known as eFT226)

Eligibility Criteria

This trial is for adults with measurable, estrogen-receptor positive endometrial cancer that's recurrent or resistant to standard treatments. They must have good organ and bone marrow function, no history of certain heart conditions or uncontrolled illnesses, and not be on conflicting medications. Women must use contraception and can't be pregnant or breastfeeding.

Inclusion Criteria

My cancer is estrogen receptor-positive.

I am fully active or can carry out light work.

Participants must have normal organ and bone marrow function as defined below: Absolute neutrophil count ≥ 1,500/mcL, Platelets ≥ 100,000/mcL, Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin </= 2.0 times ULN and direct bilirubin within normal limits are permitted, AST(SGOT)/ALT(SGPT) ≤ 3× institutional ULN, Creatinine ≤ 1.5 × institutional ULN, OR Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal

+8 more

Exclusion Criteria

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

I have had heart problems or treatments within the last 6 months.

I am not taking any strong medication that affects liver enzymes.

+11 more

Participant Groups

The study tests a combination of targeted therapies: Abemaciclib (Verzenio™), Letrozole (Femara®), with or without Metformin (Glucophage®) as potential treatments for ER+ endometrial cancer. It aims to see how well these drugs work together in treating this type of cancer.

6Treatment groups

Experimental Treatment

Group I: Cohort 5Experimental Treatment3 Interventions

* Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Zotatifin is administered intravenously on days 1 and 8 of a 21-day cycle

Group II: Cohort 4Experimental Treatment3 Interventions

* Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Zotatifin is administered intravenously on days 1 and 8 of a 21-day cycle

Group III: Cohort 3Experimental Treatment3 Interventions

* Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Metformin is administered by mouth once daily

Group IV: Cohort 2Experimental Treatment2 Interventions

* Abemaciclib is administered by mouth twice daily * LY3023414 is administered by mouth twice daily

Group V: Cohort 1AExperimental Treatment2 Interventions

* Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily

Group VI: Cohort 1Experimental Treatment3 Interventions

* Abemaciclib is administered by mouth twice daily * LY3023414 is administered by mouth twice daily * Letrozole is administered by mouth once daily

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: