NCT02846987

Brief Summary

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 Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
2mo left

Started Jul 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jul 2016Jul 2026

Study Start

First participant enrolled

July 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

10 years

First QC Date

July 25, 2016

Last Update Submit

June 4, 2025

Conditions

SarcomaDedifferentiated Liposarcoma

Keywords

Abemaciclib iLY283521916-376

Outcome Measures

Primary Outcomes (1)

  • progression-free

    Progression includes both disease progression (as defined by RECIST 1.1) and death from any cause.

    12 weeks

Study Arms (1)

Abemaciclib (LY2835219)

EXPERIMENTAL

Patients will be treated with abemaciclib 200 mg bid.

Drug: Abemaciclib

Interventions

AbemaciclibDRUG
Also known as: LY2835219
Abemaciclib (LY2835219)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +4 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

SarcomaLiposarcoma

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Adipose Tissue

Study Officials

  • Mark Dickson, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 27, 2016

Study Start

July 1, 2016

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

June 5, 2025

Record last verified: 2025-06

Locations

US(1)