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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03675893
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Letrozole — DRUG
    Letrozole is a hormonal therapy that works by lowering the production of estrogen in the body.
  • Abemaciclib — DRUG
    Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor.
  • LY3023414 — DRUG
    LY3023414 is a potent selective inhibitor of the class I PI3K isoforms, mTOR, and DNA-PK.
  • Metformin — DRUG
    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.
  • Zotatifin — DRUG
    Zotatifin is a selective eukaryotic initiation factor 4A (eIF4A) inhibitor.
  • Gedatolisib — DRUG
    Gedatolisib is a PI3K/AKT/mTOR (PAM) pathway inhibitor.

Study Details

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)

Key Dates

Start date
Dec 24, 2018
Status verified
Jun 2025
Primary completion
Aug 1, 2028
Completion
Aug 1, 2031

Study Design

Enrollment
180 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    * Abemaciclib is administered by mouth twice daily * LY3023414 is administered by mouth twice daily * Letrozole is administered by mouth once daily
  • Experimental: Cohort 2
    * Abemaciclib is administered by mouth twice daily * LY3023414 is administered by mouth twice daily
  • Experimental: Cohort 1A
    * Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily
  • Experimental: Cohort 3
    * Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Metformin is administered by mouth once daily
  • Experimental: Cohort 4
    * 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
  • Experimental: Cohort 5
    * 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
  • Experimental: Cohort 6
    * Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Gedatolisib is administered intravenously on days 1, 8 and 15 of a 28-day cycle
  • Experimental: Cohort 7
    * Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Gedatolisib is administered intravenously on days 1, 8 and 15 of a 28-day cycle

Primary Outcome Measure

Progression Free Survival Rate [ Time Frame: 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical Center (BIDMC)BostonMassachusetts02215
Meghan Shea, MD
(617) 667-5661
Meghan Shea, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Panagiotis Konstantinopoulos, MD
[email protected]
877-338-7425
Panagiotis Konstantinopoulos, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Cancer CenterBostonMassachusetts02214
Cesar Castro, MD
617-724-4000
Cesar Castro, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Endometrial cancerOvarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Beth Israel Deaconess Medical Center (BIDMC)· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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