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NCT02171260 · OUTCOME

AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Eribulin Mesylate

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
MEAN
Unit
hour * nanogram per milliliter (h*ng/mL)
Interval / dispersion
Standard Deviation
Time frame
Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose

Analysis population: The PAS included all participants who had sufficient PK data to derive at least one PK parameter.

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 hour * nanogram per milliliter (h*ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A1: Eribulin Mesylate 1.1 mg/m^2744.0353.03Not reportedNot reportedNot reported
Part A1: Eribulin Mesylate 1.4 mg/m^2758.2303.38Not reportedNot reportedNot reported
Part A1: Eribulin Mesylate 1.8 mg/m^21363.01378.53Not reportedNot reportedNot reported
Part A1: Eribulin Mesylate PK Expansion1010.8538.94Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        353.03
        value
        744.0
      2. group Id
        OG001
        spread
        303.38
        value
        758.2
      3. group Id
        OG002
        spread
        1378.53
        value
        1363.0
      4. group Id
        OG003
        spread
        538.94
        value
        1010.8
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
dispersion Type
Standard Deviation
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
MEAN
population Description
The PAS included all participants who had sufficient PK data to derive at least one PK parameter.
reporting Status
POSTED
time Frame
Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose
title
AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Eribulin Mesylate
type
PRIMARY
unit Of Measure
hour * nanogram per milliliter (h*ng/mL)

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Preserved source evidence · Not medical advice