Clinical Trials /

Study of Abemaciclib in Dedifferentiated Liposarcoma

NCT02846987

Description:

The purpose of this study is to test any good and bad effects of the study drug called Abemaciclib. Abemaciclib could shrink your cancer but it could also cause side effects. Researchers hope to learn if the study drug will delay the growth of the cancer or shrink the cancer by at least one quarter compared to its present size. Abemaciclib is not FDA approved and has not been tested in liposarcoma, but it has shrunk tumors in patients with breast cancer, lymphoma, and lung cancer.

Related Conditions:
  • Dedifferentiated Liposarcoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Abemaciclib in Dedifferentiated Liposarcoma
  • Official Title: Phase 2 Study of Abemaciclib (LY2835219) in Dedifferentiated Liposarcoma

Clinical Trial IDs

  • ORG STUDY ID: 16-376
  • NCT ID: NCT02846987

Conditions

  • Sarcoma
  • Dedifferentiated Liposarcoma

Interventions

DrugSynonymsArms
AbemaciclibLY2835219Abemaciclib (LY2835219)

Purpose

The purpose of this study is to test any good and bad effects of the study drug called Abemaciclib. Abemaciclib could shrink your cancer but it could also cause side effects. Researchers hope to learn if the study drug will delay the growth of the cancer or shrink the cancer by at least one quarter compared to its present size. Abemaciclib is not FDA approved and has not been tested in liposarcoma, but it has shrunk tumors in patients with breast cancer, lymphoma, and lung cancer.

Trial Arms

NameTypeDescriptionInterventions
Abemaciclib (LY2835219)ExperimentalPatients will be treated with abemaciclib 200 mg bid.
  • Abemaciclib

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:progression-free
Time Frame:12 weeks
Safety Issue:
Description:Progression includes both disease progression (as defined by RECIST 1.1) and death from any cause.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Abemaciclib i
  • LY2835219
  • 16-376

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