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.
PRIMARY OBJECTIVE: I. To obtain an estimate of the proportion of patients' progression-free at 16 weeks (16 week progression free survival \[PFS\] rate) in patients with recurrent ovarian (including fallopian tube and primary peritoneal) or recurrent endometrial cancer following treatment with abemaciclib as a molecularly matched targeted therapy. SECONDARY OBJECTIVE: I. To assess objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST), progression free survival (PFS) and safety following treatment with abemaciclib as a molecularly matched targeted therapy. EXPLORATORY OBJECTIVES: I. To explore the relationship between response to abemaciclib and somatic gene alterations that lead to CDK4/6 activation in ovarian cancer. II. To explore the relationship between response to abemaciclib and hormone receptor expression levels as well as somatic gene alterations that lead to CDK4/6 activation in endometrial cancer. OUTLINE: Patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Patients with tumors that are hormone receptor positive also receive anastrozole or letrozole per standard of care. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days, and then every 12 weeks up to 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGProportion of patients who are progression-free
Will be calculated with corresponding 95% unadjusted exact binomial confidence interval (CI).
Time frame: At 16 weeks
Objective response rate (ORR)
Assessed per Response Evaluation Criteria in Solid Tumors (RECIST).
Time frame: Up to 1 year
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.
Time frame: Time from registration until date of progression or death, assessed up to 1 year
Incidence of adverse events
To assess safety
Time frame: At 16 weeks and up to 90 days after completion of treatment
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.
Time frame: Up to 1 year after completion of treatment
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