Study on Abemaciclib and Letrozole with or without Metformin or Zotatifin for Endometrial or Low-Grade Serous Ovarian Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03675893

Provider View

This clinical trial is exploring a combination of targeted therapies to treat estrogen-receptor positive endometrial cancer and low-grade serous ovarian cancer. The study involves the drugs Abemaciclib, Letrozole, Metformin, and Zotatifin.

Patient Parameters

Program Overview

This study is testing a combination of drugs to see if they can help slow or stop the growth of certain types of endometrial and ovarian cancer. The drugs being tested are Abemaciclib, Letrozole, Metformin, and Zotatifin. Abemaciclib and Letrozole are already used for other conditions, while Metformin is commonly used for diabetes but is being tested here for cancer. Zotatifin is a new drug being studied. The goal is to find out if these drugs, used alone or together, can effectively treat these cancers.

Description

This is a Phase II clinical trial, which means it is testing whether the drugs are effective for treating specific types of cancer. The drugs being studied include Abemaciclib, which helps stop cancer cell growth, and Letrozole, which lowers estrogen levels to slow cancer growth. Metformin, usually used for diabetes, is being tested for its potential to stop cancer cell growth. Zotatifin is a new drug that may help stop cancer cells from growing. The study aims to see if these drugs, used alone or in combination, can slow or stop the growth of endometrial and ovarian cancer cells.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed endometrial cancer that has come back or spread, or is resistant to standard treatments.
  • For certain groups, have low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum.
  • Have estrogen-receptor positive cancer, meaning the cancer cells have a certain marker.
  • Have at least one tumor that can be measured by scans or exams.
  • Be 18 years or older.
  • Be in good overall health, with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have normal organ and bone marrow function based on specific blood tests.
  • For some groups, must not have functioning ovaries or must be on hormonal suppression.
  • Women of childbearing potential must use effective birth control during and for three months after treatment.
  • Be able to understand and sign a consent form.
  • Be able to swallow pills.
  • Have a previous tumor sample available for analysis.

Exclusion Criteria

  • Have had recent chemotherapy, immune therapy, or major surgery within four weeks before starting the study.
  • Have had recent radiation therapy within two weeks before starting the study.
  • Have previously been treated with CDK4/6 inhibitors, except for certain groups.
  • Are currently taking metformin if joining a specific group.
  • Have known brain metastases.
  • Have allergies to similar drugs being used in the study.
  • Need to take certain medications that interact with the study drugs.
  • Have uncontrolled illnesses or conditions that would interfere with the study.
  • Have a history of certain heart problems within six months before joining the study.
  • Are pregnant or breastfeeding.
  • Have had another type of cancer within the past five years, with some exceptions.
  • Are HIV-positive due to increased risk of infections.
  • Have uncontrolled high blood pressure.

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