This phase II trial studies how well abemaciclib works in treating patients with dedifferentiated liposarcoma that has come back or has spread from where it started to other places in the body and cannot be removed by surgery. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02846987.
PRIMARY OBJECTIVE:
I. To determine the proportion of patients with advanced/metastatic dedifferentiated liposarcoma who are progression-free at 12 weeks (progression-free survival [PFS], defined as Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 complete response [CR] + partial response [PR] + stable disease [SD]) when treated with abemaciclib.
SECONDARY OBJECTIVES:
I. Best overall response rate (RR) by RECIST 1.1.
II. Median progression-free survival and clinical benefit rate.
III. Overall survival.
IV. Correlate outcome with results of tumor biopsies.
OUTLINE:
Patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3-4 weeks.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMark Andrew Dickson