Actively Recruiting
Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-07-29
32
Participants Needed
1
Research Sites
349 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
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.
CONDITIONS
Official 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) cancer or endometrial cancer
- Molecular tumor board confirms CDK4/6 activation features in ovarian cancer tumor specimen
- Molecular tumor board confirms endometrial cancer specimen is 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 ovarian or endometrial cancer
- Recovery from chemotherapy effects (CTCAE grade ≤ 1) except alopecia or grade 2 peripheral neuropathy; minimum 21-day washout after last chemotherapy
- Recovery from radiotherapy effects; minimum 14-day washout after radiotherapy
- Ability to swallow oral medications
- ECOG performance status of 0-2
- Willingness and ability to comply with visits, treatments, tests, and procedures
- Written informed consent obtained prior to study procedures
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 8 g/dL; erythrocyte transfusions allowed before treatment
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN); patients with Gilbert's syndrome allowed if bilirubin ≤ 2.0 x ULN and direct bilirubin normal
- ALT and AST ≤ 3 x ULN
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose and agree to use highly effective contraception during treatment and for 3 weeks after last dose
You will not qualify if you...
- Anticipated need for major surgery or radiation therapy during the trial
- Diagnosis of second malignancy within 5 years except treated basal or squamous cell skin cancer or in situ carcinoma of cervix or breast
- Treatment with chemotherapy, surgery, blood products, or investigational agent within 3 weeks prior to enrollment
- History within 6 months of myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass graft, NYHA class III or IV heart failure, stroke or transient ischemic attack, pulmonary embolism
- Unstable brain metastases or carcinomatous meningitis
- Pregnant or breastfeeding women of childbearing potential
- Unwillingness to use adequate contraception if of childbearing potential
- Serious preexisting medical conditions that would interfere with study participation or safety (e.g., interstitial lung disease, severe dyspnea requiring oxygen, major stomach or small bowel surgery, Crohn's disease, ulcerative colitis, grade 2 or higher baseline diarrhea)
- Active bacterial infection requiring IV antibiotics, fungal infection, or detectable viral infection such as HIV or active hepatitis B or C
- Personal history of syncope of cardiovascular cause, pathological ventricular arrhythmia, or sudden cardiac arrest
- Current use or anticipated need for strong CYP3A4 inhibitors (list provided)
- Other severe acute or chronic medical or psychiatric conditions or significant lab abnormalities that may pose undue risk or interfere with trial results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
K
Kimberly Kelly
CONTACT
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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