Actively Recruiting
An Open Label Phase II Study of Abemaciclib, a CDK4/6 Inhibitor, in Patients with Recurrent Ovarian or Endometrial Cancer
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-07-29
32
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well abemaciclib works for women with recurrent ovarian or endometrial cancer that involves activation of the CDK4/6 pathway. This phase II trial aims to measure how many patients remain free from cancer progression at 16 weeks and to assess the treatment's response rate, progression-free survival, and safety. The study also explores how genetic changes and hormone receptor levels relate to treatment response in these cancers. Participants receive abemaciclib by mouth twice daily in 28-day cycles. Those with hormone receptor-positive tumors also take anastrozole or letrozole following standard care. Treatment continues as long as the cancer does not worsen and side effects are manageable. After treatment ends, patients are followed for 30 days, then every 12 weeks for up to one year to monitor their health. During the study, patients undergo regular visits for treatment, tests, and assessments. Researchers evaluate cancer progression using established criteria and monitor for side effects and overall benefit. Blood tests confirm eligibility and safety, and participants must be able to take oral medications and maintain their scheduled visits. The main outcome measured is the proportion of patients without cancer progression at 16 weeks.
CONDITIONS
Brief Title
Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed ovarian epithelial (including fallopian tube and primary peritoneal) or endometrial cancer
- Tumor shows CDK4/6 activation confirmed by molecular profiling
- Endometrial cancer tumors must be endometrioid histology with positive hormone receptor expression and no Cyclin E gene amplification or retinoblastoma gene loss
- At least one prior chemotherapy regimen for recurrent cancer with recovery from acute effects (except alopecia or grade 2 neuropathy)
- Completed and recovered from radiotherapy at least 14 days prior to study start
- Ability to swallow oral medications
- ECOG performance status of 0-2
- Willingness and ability to comply with visits, treatment, and tests
- Informed consent obtained
- Adequate blood counts and liver function tests
- Negative pregnancy test and agreement to use effective contraception if of childbearing potential
You will not qualify if you...
- Need for immediate major surgery or radiation during the trial
- Diagnosis of a second malignancy within 5 years (exceptions apply)
- Recent treatment (chemotherapy, surgery, investigational agents) within 3 weeks
- History of serious cardiovascular events within 6 months
- Unstable brain metastases or carcinomatous meningitis
- Pregnant or breastfeeding women, or unwillingness to use contraception if of childbearing potential
- Serious preexisting medical conditions that increase risk or interfere with study
- Active infections requiring IV antibiotics or known active viral infections
- Personal history of serious cardiac arrhythmias or sudden cardiac arrest
- Current or anticipated use of strong CYP3A4 inhibitors
- Other severe acute or chronic conditions or lab abnormalities that pose undue risk or interfere with participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive abemaciclib orally twice daily on days 1-28 of each cycle. Those with hormone receptor positive tumors also receive anastrozole or letrozole per standard of care. Treatment cycles repeat every 28 days until disease progression or unacceptable toxicity.
Visits occur every 28 days with each treatment cycle
Duration - 30 days initially, then every 12 weeks up to 1 year
After completing study treatment, participants are followed up to monitor safety and disease status.
Follow-up visits every 12 weeks for up to 1 year
Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
G
Gina A Khachatrian
K
Kimberly Kelly
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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