Study of Abemaciclib in Dedifferentiated Liposarcoma

Inclusion Criteria:

- A diagnosis of dedifferentiated liposarcoma confirmed at 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 2 4 weeks prior to
initiation of therapy. Patients receiving 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.

- Age ≥ 18 years.

- ECOG performance status 0 or 1

- Adequate organ and marrow function as defined below (ULN indicates institutional upper
limit of normal):

- Absolute neutrophil count ≥ 1.510^9/L

- Hemoglobin ≥ 8.0 g/dL

- WBC ≥ 3.0 x 10^9/L

- Platelets ≥ 100 x 10^9/L

- Total bilirubin ≤ 1.5 x ULN except for patients with known Gilbert syndrome

- AST(SGOT)/ALT(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

Exclusion Criteria:

- Patients who have not recovered from adverse events of prior therapy to ≤ NCI
CTCAEv4.0 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 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.