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
Jonsson Comprehensive Cancer Center
Lead sponsor
Eli Lilly and Company
Collaborator