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

PHASE2RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

December 24, 2018

Primary Completion Date

August 1, 2028

Study Completion Date

August 1, 2031

Conditions
Endometrial CancerOvarian Cancer
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.

Trial Locations (3)

02214

RECRUITING

Massachusetts General Hospital Cancer Center, Boston

02215

RECRUITING

Beth Israel Deaconess Medical Center (BIDMC), Boston

RECRUITING

Dana Farber Cancer Institute, Boston

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

collaborator

Effector Therapeutics

INDUSTRY

collaborator

Celcuity Inc

INDUSTRY

lead

Dana-Farber Cancer Institute

OTHER