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.
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
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
Single group
Abemaciclib
DrugGiven PO
Anastrozole
DrugGiven PO
Letrozole
DrugGiven PO
Proportion of patients who are progression-free
Will be calculated with corresponding 95% unadjusted exact binomial confidence interval (CI).
Objective response rate (ORR)
Assessed per Response Evaluation Criteria in Solid Tumors (RECIST).
Progression free survival (PFS)
Date of progression will be defined as the date of the first imaging or clinical exam or biochemical occurrence showing disease progression. PFS will be calculated with corresponding 95% unadjusted exact binomial confidence interval. Kaplan-Meier estimates and Kaplan Meier plots of this endpoint will be produced. Two-sided 95% confidence intervals will accompany the Kaplan-Meier estimate of the median.
Incidence of adverse events
To assess safety
Clinical benefit rate
Defined as achieving a confirmed objective response (complete response \[CR\] or partial response \[PR\]) or achieving stable disease for a minimum duration of 4 months, will be provided with the exact two-sided 95% confidence interval.
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Jonsson Comprehensive Cancer Center
Lead sponsor
Eli Lilly and Company
Collaborator
