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NCT03441360 · FLOW

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Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS) · Source last updated 2022-10-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Pediatric participants with rhabdomyosarcoma (RMS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 milligrams per meter square (mg/m\^2). Participants continued to receive study therapy until progression of disease, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    FG000
    title
    Eribulin Mesylate 1.4 mg/m^2: RMS
  2. description
    Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    FG001
    title
    Eribulin Mesylate 1.4 mg/m^2: NRSTS
  3. description
    Pediatric participants with Ewing sarcoma (EWS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    FG002
    title
    Eribulin Mesylate 1.4 mg/m^2: EWS
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      Radiological disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Clinical disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 24 participants were screened, of which 1 was screen failure and 23 participants were enrolled, out of which 21 participants were randomized and treated in the study and 2 were not treated due to withdrawal of consent and rapid disease progression (1 participant from each arm).
recruitment Details
Participants took part in the study at 38 investigative sites in the United States from 17 April 2018 to 21 January 2022.
Complete source fields
groups
  1. description
    Pediatric participants with rhabdomyosarcoma (RMS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 milligrams per meter square (mg/m\^2). Participants continued to receive study therapy until progression of disease, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    FG000
    title
    Eribulin Mesylate 1.4 mg/m^2: RMS
  2. description
    Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    FG001
    title
    Eribulin Mesylate 1.4 mg/m^2: NRSTS
  3. description
    Pediatric participants with Ewing sarcoma (EWS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    FG002
    title
    Eribulin Mesylate 1.4 mg/m^2: EWS
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      Radiological disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Clinical disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 24 participants were screened, of which 1 was screen failure and 23 participants were enrolled, out of which 21 participants were randomized and treated in the study and 2 were not treated due to withdrawal of consent and rapid disease progression (1 participant from each arm).
recruitment Details
Participants took part in the study at 38 investigative sites in the United States from 17 April 2018 to 21 January 2022.

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Preserved source evidence · Not medical advice