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RESOLVE: Abemaciclib + Letrozole +/- Metformin or Zotatifin in Endometrial or Low-Grade Serous Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:
RESOLVE: letRozole abEmaciclib combinationS in endOmetriaL and oVarian cancEr: A Multi-Cohort Phase 2 Study of Letrozole/Abemaciclib Alone and in Combination With Metformin and Zotatifin

Clinical Trial Summary

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)

Clinical Trial Description

This is a Phase II clinical trial. Phase II clinical trials evaluate whether investigational drugs are effective against a specific disease. "Investigational" means that the drugs are being studied. The U.S. Food and Drug Administration (FDA) has not approved abemaciclib or letrozole for your specific disease but it has been approved for other uses. The FDA has approved metformin for diabetes but is considered investigational for its use in cancer. The FDA has not approved zotatifin as a treatment for any disease. Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor. CDK inhibitors work to stop cancer cell growth. Letrozole is a hormonal therapy that works by lowering the production of estrogen in your body. Estrogen may help to stimulate cancer cells to grow, so lowering the levels of estrogen in your body may work to slow cancer cell growth. Metformin is an antihyperglycemic drug most commonly used to lower the amount of blood sugar in the blood and increase the body's sensitivity to insulin. Metformin also works on cancer cells to stop cancer cell growth and promote cancer cell death. Zotatifin is a selective eukaryotic initiation factor 4A (eIF4A) inhibitor. Selective eIF4A inhibition works by stopping cancer cell growth and enhancing CDK inhibition. In this research study, we are hoping to learn whether the combination of abemaciclib and letrozole alone, with metformin, or with zotatifin is effective at slowing or stopping endometrial and/or ovarian cancer cell growth. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03675893
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Panagiotis Konstantinopoulos, MD
Phone 877-338-7425
Email PanagiotisA_Konstantinopoulos@DFCI.HARVARD.EDU
Status Recruiting
Phase Phase 2
Start date December 24, 2018
Completion date August 1, 2029
View Details
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