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Abemaciclib in Treating Patients with Recurrent, Locally Advanced, or Metastatic Dedifferentiated Liposarcoma That Cannot Be Removed by Surgery

Trial Status: Active

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.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Mark Andrew Dickson
Phone: 646-888-4164

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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Mark Andrew Dickson

  • Primary ID 16-376
  • Secondary IDs NCI-2016-01223
  • Clinicaltrials.gov ID NCT02846987