Abemaciclib for Treating Recurrent Ovarian or Endometrial Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04469764

Provider View

This study is testing how well the drug abemaciclib works for patients with ovarian or endometrial cancer that has returned and involves a specific cell growth pathway. The drug may help stop tumor growth by blocking certain enzymes needed for cell growth.

Patient Parameters

Program Overview

This phase II study is exploring the effectiveness of abemaciclib in treating patients with ovarian or endometrial cancer that has come back and involves the CDK4/6 pathway. Abemaciclib may help stop the growth of cancer cells by blocking enzymes necessary for cell growth. The study aims to see if abemaciclib is more effective for treating these recurrent cancers.

Description

The main goal of this study is to find out how many patients remain free from cancer progression 16 weeks after starting treatment with abemaciclib. This drug is used as a targeted therapy for patients with recurrent ovarian or endometrial cancer.

Secondary goals include assessing how well the cancer responds to treatment, how long patients remain free from cancer progression, and the safety of abemaciclib.

Researchers will also explore how genetic changes in the cancer and hormone receptor levels affect the response to abemaciclib.

Patients will take abemaciclib by mouth twice a day in 28-day cycles. If their tumors are hormone receptor positive, they will also receive anastrozole or letrozole as part of standard care. Treatment cycles will continue as long as the cancer does not progress and side effects are manageable.

After finishing the study treatment, patients will be monitored for 30 days and then every 12 weeks for up to a year.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of ovarian or endometrial cancer.
  • Cancer must show activation of the CDK4/6 pathway based on genetic testing.
  • Have had at least one previous chemotherapy treatment for recurrent cancer.
  • Must have recovered from any side effects of previous treatments.
  • Be able to swallow pills.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Agree to follow study procedures and attend scheduled visits.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after treatment.

Exclusion Criteria

  • Need for major surgery or radiation therapy during the study.
  • Have another cancer diagnosed within the last 5 years, except for certain skin or cervical cancers.
  • Recent treatment with chemotherapy, surgery, or investigational drugs.
  • Recent serious heart or blood vessel problems.
  • Unstable brain metastases or cancer in the brain lining.
  • Pregnant or breastfeeding women.
  • Not willing to use effective birth control.
  • Have serious medical conditions that could interfere with the study.
  • Have active infections or certain viral infections.
  • Have a history of serious heart rhythm problems.
  • Currently using or needing certain medications that interact with the study drug.
  • Have other severe medical or psychiatric conditions that could affect safety or study participation.

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