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A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma

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ClinicalTrials.gov Identifier: NCT03810976
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : June 16, 2022
Information provided by (Responsible Party):
Hyo Song Kim, Yonsei University

Brief 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, investigators suggest phase II trial of eribulin and gemcitabine combination in previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or liposarcoma.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: Eribulin, gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients With Advanced Liposarcoma or Leiomyosarcoma
Actual Study Start Date : March 27, 2018
Actual Primary Completion Date : May 30, 2022
Actual Study Completion Date : May 30, 2022

Arm Intervention/treatment
Experimental: eribulin+gemcitabine
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.
Drug: Eribulin, gemcitabine
Elibulin 1.4mg/m2 Intravenous for 5minutes. Day 1& Day 8 every 3 weeks Gemcitabine 1000mg/m2 intraveoust for 30 minutes, Day 1& Day 8 every 3 weeks

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 12 weeks ]
    To evaluate antitumor efficacy of eribulin and gemcitabine combination

Secondary Outcome Measures :
  1. adverse event [ Time Frame: through study completion, an average of 6 months ]
    to evaluate safety

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed advanced liposarcoma or leiomyosarcoma with 1-2 prior chemotherapy including anthracycline (unless contraindicated)
  2. ECOG performance status of 0-2
  3. Measurable or evaluable disease (RECIST 1.1.)
  4. Adequate laboratory findings

    • Hb ≥ 9.0 g/dL
    • Absolute neutrophil count ≥ 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 : ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver or bone metastasis)
    • Prothrombin time and partial thromboplastin time : ≤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 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

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): NCT03810976

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Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
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Responsible Party: Hyo Song Kim, professor, Yonsei University
ClinicalTrials.gov Identifier: NCT03810976    
Other Study ID Numbers: 4-2017-0933
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Neoplasms, Adipose Tissue
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs