Study of Abemaciclib in Dedifferentiated Liposarcoma

Phase 2 Study of Abemaciclib (LY2835219) in Dedifferentiated Liposarcoma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sarcoma; Dedifferentiated Liposarcoma
• Intervention / Treatment: Drug: Abemaciclib

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abemaciclib (LY2835219); Patients will be treated with abemaciclib 200 mg bid.	Drug: Abemaciclib; Other Names: LY2835219

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Mark Dickson, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimated): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: LY2835219; Abemaciclib i; 16-376
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Adipose Tissue; Liposarcoma
• Other Study ID Numbers: 16-376