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NCT02171260 · OUTCOME

Number of Participants With Clinically Significant Vital Sign Values

This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas · Source last updated 2019-01-15

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)

Analysis population: The SAS included all participants who received at least one dose of study drug.

Groups in this outcome

Part A1: Eribulin Mesylate 1.1 mg/m^2

Participants received eribulin mesylate 1.1 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.

Part A1: Eribulin Mesylate 1.4 mg/m^2

Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.

Part A1: Eribulin Mesylate 1.8 mg/m^2

Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.

Part A1: Eribulin Mesylate PK Expansion

Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.

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

Analysis denominator · Participants

GroupSource count
Part A1: Eribulin Mesylate 1.1 mg/m^26
Part A1: Eribulin Mesylate 1.4 mg/m^26
Part A1: Eribulin Mesylate 1.8 mg/m^25
Part A1: Eribulin Mesylate PK Expansion5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A1: Eribulin Mesylate 1.1 mg/m^20Not reportedNot reportedNot reportedNot reported
Part A1: Eribulin Mesylate 1.4 mg/m^20Not reportedNot reportedNot reportedNot reported
Part A1: Eribulin Mesylate 1.8 mg/m^20Not reportedNot reportedNot reportedNot reported
Part A1: Eribulin Mesylate PK Expansion0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      5
    units
    Participants
groups
  1. description
    Participants received eribulin mesylate 1.1 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
    id
    OG000
    title
    Part A1: Eribulin Mesylate 1.1 mg/m^2
  2. description
    Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
    id
    OG001
    title
    Part A1: Eribulin Mesylate 1.4 mg/m^2
  3. description
    Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
    id
    OG002
    title
    Part A1: Eribulin Mesylate 1.8 mg/m^2
  4. description
    Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
    id
    OG003
    title
    Part A1: Eribulin Mesylate PK Expansion
param Type
COUNT_OF_PARTICIPANTS
population Description
The SAS included all participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
title
Number of Participants With Clinically Significant Vital Sign Values
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice