Abemaciclib in Treating Patients with Recurrent, Locally Advanced, or Metastatic Dedifferentiated Liposarcoma That Cannot Be Removed by Surgery
- A diagnosis of dedifferentiated liposarcoma confirmed at Memorial Sloan Kettering Cancer Center (MSKCC)
- Metastatic and/or locally advanced or locally recurrent disease that is not surgically resectable
- All patients must have measurable disease as defined by RECIST 1.1; patients must also have evidence of disease progression by RECIST 1.1 within 6 months of first dose of study drug
- Any number of prior therapies (including none) is permitted; the last dose of systemic therapy (include targeted therapies) must have been given at least 4 weeks prior to initiation of therapy; patients receiving carmustine (BCNU) or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy
- Patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Absolute neutrophil count >= 1.5 x 10^9/L
- Hemoglobin >= 8.0 g/dL
- White blood cells (WBC) >= 3.0 x 10^9/L
- Platelets >= 100 x 10^9/L
- Total bilirubin =< 1.5 x upper limit of normal (ULN) except for patients with known Gilbert syndrome
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional ULN
- Creatinine =< 1.5 x ULN or creatinine clearance > 50 mL/min (calculated by Cockcroft-Gault method)
- Patients must not have current evidence of another malignancy that requires treatment
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence); women must not breast feed while on study
- Ability to understand and the willingness to sign a written informed consent document
- Ability to swallow capsules
- Patients who have not recovered from adverse events of prior therapy to =< National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1
- Patients receiving any other investigational agents
- Patients who have received prior treatment with a selective CDK4 inhibitor
- Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including human immunodeficiency virus (HIV), active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women and women who are breast-feeding
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.
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.
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.
Trial Phase Phase II
Trial Type Treatment
Memorial Sloan Kettering Cancer Center
Mark Andrew Dickson
- Primary ID 16-376
- Secondary IDs NCI-2016-01223
- Clinicaltrials.gov ID NCT02846987