RecruitingPhase 2NCT03675893

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

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


Sponsor

Dana-Farber Cancer Institute

Enrollment

180 participants

Start Date

Dec 24, 2018

Study Type

INTERVENTIONAL

Conditions

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) * Gedatolisib (also known as PF-05212384)


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing various combinations of targeted drugs — including abemaciclib, letrozole, metformin, zotatifin, and gedatolisib — for women with endometrial cancer (uterine cancer) or low-grade serous ovarian cancer that has come back or spread after prior treatment. **You may be eligible if...** - You have been diagnosed with recurrent or metastatic endometrial cancer, or low-grade serous ovarian cancer - Your cancer has been confirmed by biopsy - You have had prior standard treatment but your cancer continued to grow or came back - You are in adequate overall health with acceptable organ function **You may NOT be eligible if...** - You have had too many prior chemotherapy regimens (specific limits apply per study group) - You have active brain metastases - You have serious heart problems (such as uncontrolled high blood pressure or a recent heart attack) - You are pregnant or breastfeeding - You are on medications that significantly interact with the study drugs - You have uncontrolled diabetes (for groups including metformin) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLetrozole

Letrozole is a hormonal therapy that works by lowering the production of estrogen in the body.

DRUGAbemaciclib

Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor.

DRUGLY3023414

LY3023414 is a potent selective inhibitor of the class I PI3K isoforms, mTOR, and DNA-PK.

DRUGMetformin

Metformin inhibits mitochondrial adenosine-5'-triphosphate (ATP) synthesis, resulting in activation of the AMPK (5' AMP-activated protein kinase) pathway through LKB1, eventually causing inhibition of the mTOR pathway and subsequent reduction in protein synthesis and cellular proliferation.

DRUGZotatifin

Zotatifin is a selective eukaryotic initiation factor 4A (eIF4A) inhibitor.

DRUGGedatolisib

Gedatolisib is a PI3K/AKT/mTOR (PAM) pathway inhibitor.


Locations(3)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03675893


Related Trials