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NCT03441360 · OUTCOME

Overall Survival (OS)

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the day of first dose to the day of death, up to approximately 45 months

What was measured

OS was defined as the time from the first dose date to the date of death.

Analysis population: The FAS included all participants who receive at least 1 dose of study drug.

Groups in this outcome

Eribulin Mesylate 1.4 mg/m^2: RMS

Pediatric participants with RMS 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.

Eribulin Mesylate 1.4 mg/m^2: NRSTS

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.

Eribulin Mesylate 1.4 mg/m^2: EWS

Pediatric participants with 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Eribulin Mesylate 1.4 mg/m^2: RMS8
Eribulin Mesylate 1.4 mg/m^2: NRSTS8
Eribulin Mesylate 1.4 mg/m^2: EWS5

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Eribulin Mesylate 1.4 mg/m^2: RMS5.08Not reported1.746.47Not reported
Eribulin Mesylate 1.4 mg/m^2: NRSTS6.95Not reported0.7216.26Not reported
Eribulin Mesylate 1.4 mg/m^2: EWS7.89Not reported2.5029.80Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.74
        upper Limit
        6.47
        value
        5.08
      2. group Id
        OG001
        lower Limit
        0.72
        upper Limit
        16.26
        value
        6.95
      3. group Id
        OG002
        lower Limit
        2.50
        upper Limit
        29.80
        value
        7.89
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      5
    units
    Participants
description
OS was defined as the time from the first dose date to the date of death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Pediatric participants with RMS 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
    OG000
    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
    OG001
    title
    Eribulin Mesylate 1.4 mg/m^2: NRSTS
  3. description
    Pediatric participants with 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
    OG002
    title
    Eribulin Mesylate 1.4 mg/m^2: EWS
param Type
MEDIAN
population Description
The FAS included all participants who receive at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From the day of first dose to the day of death, up to approximately 45 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice