MedTrace Logo

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

NCT03675893 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-06-15

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Letrozole

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

DRUG

Abemaciclib

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

DRUG

LY3023414

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

DRUG

Metformin

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.

DRUG

Zotatifin

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

DRUG

Gedatolisib

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

Sponsors & Collaborators

Principal Investigators

  • Panagiotis Konstantininopoulos, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-24
Primary Completion
2028-08-01
Completion
2031-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03675893 on ClinicalTrials.gov