RecruitingPhase 2NCT04469764

Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer

An Open Label Phase II Study of the Efficacy and Safety of Abemaciclib, a Cyclin Dependent Kinase (CDK4/6) Inhibitor in Selected Patients With Recurrent Ovarian or Endometrial Cancer


Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

32 participants

Start Date

Oct 16, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well abemaciclib works in treating patients with ovarian or endometrial cancer that has an activation of the CDK4/6 pathway and that has come back (recurrent). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib may work better for the treatment of recurrent ovarian and endometrial cancer.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is testing abemaciclib — a drug that blocks specific proteins driving cancer cell growth — in patients with recurrent ovarian cancer or endometrial cancer whose tumors have specific genetic features. This "precision medicine" approach targets patients whose tumors are most likely to respond. **You may be eligible if:** - You have ovarian, fallopian tube, primary peritoneal, or endometrial cancer that has come back after treatment - For ovarian cancer: your tumor has been tested and shows CDK4/6 activation - For endometrial cancer: your tumor is endometrioid type, hormone receptor-positive, and does not have CCNE amplification or RB loss - You have received at least one prior chemotherapy regimen for recurrent disease - You have recovered from the side effects of your prior treatment - You are able to swallow oral medications - Your general health score (ECOG) is 0-2 **You may NOT be eligible if:** - Your tumor does not have the required molecular features - You have not yet had prior chemotherapy for recurrent disease - You have not recovered from chemotherapy or radiation side effects (still at grade 2+ except stable neuropathy) - You have serious organ dysfunction or active infections 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.

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Interventions

DRUGAbemaciclib

Given PO

DRUGAnastrozole

Given PO

DRUGLetrozole

Given PO


Locations(1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

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NCT04469764


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