Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Abemaciclib in Dedifferentiated Liposarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02846987
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Sarcoma Dedifferentiated Liposarcoma Drug: Abemaciclib Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Abemaciclib (LY2835219) in Dedifferentiated Liposarcoma
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Abemaciclib

Arm Intervention/treatment
Experimental: Abemaciclib (LY2835219)
Patients will be treated with abemaciclib 200 mg bid.
Drug: Abemaciclib
Other Name: LY2835219




Primary Outcome Measures :
  1. progression-free [ Time Frame: 12 weeks ]
    Progression includes both disease progression (as defined by RECIST 1.1) and death from any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846987


Contacts
Layout table for location contacts
Contact: Mark Dickson, MD 646-888-4164
Contact: William Tap, MD 646-888-4163

Locations
Layout table for location information
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mark Dickson, MD    646-888-4164      
Contact: William Tap, MD    646-888-4163      
Principal Investigator: Mark Dickson, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Eli Lilly and Company
Investigators
Layout table for investigator information
Principal Investigator: Mark Dickson, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02846987     History of Changes
Other Study ID Numbers: 16-376
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: July 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
Abemaciclib i
LY2835219
16-376
Additional relevant MeSH terms:
Layout table for MeSH terms
Liposarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Adipose Tissue