Abemaciclib for Recurrent Ovarian or Endometrial Cancer
This study is looking at how well abemaciclib works for people with ovarian, fallopian tube, primary peritoneal, or endometrial cancer that has come back (recurrent). Your tumor must show specific features of "CDK4/6 activation" to be eligible. Abemaciclib is a targeted therapy that aims to stop cancer cells from growing by blocking certain enzymes. Some patients will also receive anastrozole or letrozole if their tumors are hormone receptor positive. The main goal is to see what percentage of patients are progression-free (meaning their cancer has not gotten worse) after 16 weeks of treatment. This study is for women and plans to enroll 32 participants.
- Study design
- This is an interventional study with a planned enrollment of 32 women. It is a single-arm study, meaning all participants receive the same treatment.
- What's involved
- You would take abemaciclib by mouth twice a day for 28-day cycles. If your tumor is hormone receptor positive, you would also take anastrozole or letrozole by mouth.
- Compensation
- Not stated in the trial record.
- Follow-up
- After your study treatment ends, you will have follow-up appointments for 30 days, and then every 12 weeks for up to one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04469764
Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer
Recruiting
PHASE2All AgesInterventionalTreatmentJonsson Comprehensive Cancer CenterInvestigator-initiated
~32 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:AbemaciclibAnastrozoleLetrozole
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients who are progression-free
Measured over At 16 weeks
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Gottfried E Konecny · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) cancer or endometrial cancer
Molecular tumor board confirms that patient's archival ovarian cancer tumor specimen has been assessed using standard of care genomic profiling and demonstrates CDK4/6 activation features
Molecular tumor board confirms that patient's archival endometrial cancer tumor specimen has been assessed using standard of care genomic profiling and is of endometrioid histology, has positive hormone receptor expression and lack of Cyclin E gene (CCNE) amplification or retinoblastoma susceptibility gene product (RB) loss
At least one prior chemotherapy regimen for the treatment of recurrent ovarian or endometrial cancer
Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] grade =\< 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and study initiation
Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and study initiation
The patient is able to swallow oral medications
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Informed consent must be obtained in writing for all patients prior to performing study/screening procedures and prior to registration into the study
Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
Platelets \>= 100 x 10\^9/L
Hemoglobin \>= 8 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion
Total bilirubin =\< 1.5 x upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin =\< 2.0 times ULN and direct bilirubin within normal limits are permitted
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN
Female participants of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of abemaciclib and agree to use a highly effective contraception method during the treatment period and for 3 weeks following the last dose of abemaciclib
Exclusion
Anticipation of immediate need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the trial
Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri or breast
Treatment with chemotherapy, surgery, blood products, or an investigational agent within 3 weeks of trial enrollment
Any of the following within 6 months prior to trial registration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism
Unstable brain metastases or carcinomatous meningitis
Patient of child-bearing potential is evidently pregnant or is breast feeding. A woman with child bearing potential is defined as not surgically sterile or being post-menopausal for less than 6 months
Patient of child-bearing potential is not willing to use adequate contraceptive precautions. Adequate effective method of contraception are those which result in low failure rates, less than 1% per year, such as non-hormonal intrauterine device (IUD), condoms, sexual abstinence or vasectomized partner
The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)
The patient has active bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment
The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
Current use or anticipated need for: Food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, tilithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delaviridine)
Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial
What this trial measures
- Proportion of patients who are progression-freeAt 16 weeks
Will be calculated with corresponding 95% unadjusted exact binomial confidence interval (CI).