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Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients with Advanced Liposarcoma or Leiomyosarcoma.

Status Approved

  • First Submitted Date

    2019/01/11

  • Registered Date

    2019/02/22

  • Last Updated Date

    2019/02/11

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003547
    Unique Protocol ID 4-2017-0933
    Public/Brief Title A study to evaluatethe safety and efficacy of eribulin in combination with gemcitabine in previously treated patients with advanced Liposarcoma or Leimyosarcoma.
    Scientific Title Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients with Advanced Liposarcoma or Leiomyosarcoma.
    Acronym
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 4-2017-0933
    Approval Date 2017-11-22
    Institutional Review Board Name Yonsei University Health System, Severance Hospital, Institutional Review Board
    Institutional Review Board Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Institutional Review Board Telephone 02-2228-0435
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Hyosong Kim
    Title MD
    Telephone +82-2-2228-8124
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1 Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Public Queries
    Name Jeongrim Choo
    Title CRC
    Telephone +82-2-2228-8048
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1 Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Updating Information
    Name Jeongrim Choo
    Title CRC
    Telephone +82-2-2228-8048
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1 Yonsei-ro, Seodaemun-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 3
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2018-03-20 Actual
    Target Number of Participant 37
    Primary Completion Date 2019-02-28 , Anticipated
    Study Completion Date 2019-08-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-03-20 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Asan Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2019-03-29 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Samsung Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2019-03-29 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Chong Kun Dang
    Organization Type Pharmaceutical Company
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University Health System, Severance Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The eribulin, a microtubule-dynamics inhibitor was approved for specific subtypes of STS. Eribulin demonstrated significantly better OS compared to dacarbazine in previously treated patients with liposarcoma and leiomyosarcoma and approved as standard treatment.  However, the median progression free survival (PFS) and response rate (RR) was similar for both groups which remains modest outcome of 2.6 months of PFS and 4% of RR. Therefore, to improve antitumor activity, further combination strategy is strongly warranted. Based on the previous studies, we suggest phase II trial of eribulin and gemcitabine combination in previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or liposarcoma.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase2
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Non-RCT
    Intervention Type Drug  
    Intervention Description
    Patient with metastatic/ recurrent liposarcoma and Leisarcoma who had previously one or two chemotherapy with eeibuline and gemcitabine is repeated untile the disease progression. 
    Syringe the required amount of eribulin from the appropriate number of vials. The dose is 1.4 mg / m2 for 5 minutes intravenously. If necessary, the dose may be diluted in up to 100 mL of saline solution prior to intravenous administration. Gemcitabine doses 1000 mg / m2 intravenously for 30 minutes. After completion of the eribulin injection, intravenously inject gemcitabine. One cycle is 3 weeks, and the treatment is carried out on the 1st day and the 8th day for each cycle.
    Number of Arms 1
    Arm 1

    Arm Label

    Eribulin, Gemcitabine

    Target Number of Participant

    37

    Arm Type

    Experimental

    Arm Description

    Elibulin 1.4mg/m2 Intravenous for 5minutes. 
    Gemcitabine 1000mg/m2 intraveoust for 30 minutes. 
    Day 1& Day 8 every 3 weeks.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C41.9)Malignant neoplasm of bone and articular cartilage, unspecified 

    Liposarcoma or Leiomyosarcoma
    Rare Disease Yes
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    1.Histologically confirmed advanced liposarcoma or leiomyosarcoma with 1-2 prior chemotherapy including anthracycline (unless contraindicated) : neoadjuvnat or adjuvant chemotherapy is counted as one regimen
    2. ECOG(Eastern Cooperative Oncology Group) performance status of 0-2
    3. Measurable or evaluable disease (RECIST 1.1.) 
    4. Adequate laboratory findings
    - Hemoglobin ≥ 9.0 g/dL 
    - Absolute neutrophil count (ANC) ≥ 1000 /µL 
    - Platelet ≥ 75,000/ µL
    - Total Bilirubin:  ≤ 1.5 × UNL (upper normal limit) (≤ 2 × UNL in patients with liver metastasis)
    - Serum Creatinine: ≤1.5 X upper limit of normal (ULN) OR ≥ Creatinine Clearance 60 mL/min (Cockcroft-Gault) for patients with creatinine levels > 1.5 X institutional ULN 
    - AST(SGOT)/ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis)
    - Alkaline Phosphatase (ALP): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver or bone metastasis)
    - Prothrombin time and partial thromboplastin time (PTT) : ≤1.5 X ULN
    5.Female patient of childbearing potential has a negative serum or urine pregnancy  test within 72 hours prior
    Exclusion Criteria
    1. More than 3 prior cytotoxic agents 
    2. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2  weeks prior to entering the study 
    3. Uncontrolled or active CNS(Central nervous system) metastasis and/or carcinomatous meningitis  
    4. Patient has known hypersensitivity to the components of study drugs or its analogs.
    5. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
    6. Long QT Syndrome ≥480 ms
    7. peripheral neuropathy ≥2 with previous treatment 
    8. unstable cardiovascular disease 
    9. Symptomatic interstitial lung disease (ILD) or presence of ILD on chest X-ray
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Progression free survival rate at 12 weeks
    Timepoint
    every 6weeks up to 12weeks : will be based on RECIST version 1.1
    Secondary Outcome(s) 1
    Outcome
    Adverse event
    Timepoint
    Every visit
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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