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Study of Abemaciclib in Dedifferentiated Liposarcoma

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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

Tracking Information
First Submitted Date  ICMJE July 25, 2016
First Posted Date  ICMJE July 27, 2016
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
progression-free [ Time Frame: 12 weeks ]
Progression includes both disease progression (as defined by RECIST 1.1) and death from any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02846987 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Abemaciclib in Dedifferentiated Liposarcoma
Official Title  ICMJE Phase 2 Study of Abemaciclib (LY2835219) in Dedifferentiated Liposarcoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sarcoma
  • Dedifferentiated Liposarcoma
Intervention  ICMJE Drug: Abemaciclib
Other Name: LY2835219
Study Arms  ICMJE Experimental: Abemaciclib (LY2835219)
Patients will be treated with abemaciclib 200 mg bid.
Intervention: Drug: Abemaciclib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2019)
33
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2016)
30
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark Dickson, MD 646-888-4164
Contact: William Tap, MD 646-888-4163
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02846987
Other Study ID Numbers  ICMJE 16-376
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Mark Dickson, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP