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NCT00586924 · OUTCOME

AUC Accumulation Ratio of Moxetumomab Pasudotox for Cycle 1

A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia · Source last updated 2019-04-02

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

Measure
MEDIAN
Unit
ratio
Interval / dispersion
Full Range
Time frame
Cycle 1 Day 1 and Day 5: pre-infusion, at 15 min during the infusion, at the end of infusion, and at 1, 1.5, 2, 4, 8, and 12 h post infusion

What was measured

The AUC accumulation ratio of moxetumomab pasudotox was calculated as the geometric mean ratio of AUC(0-last) on the last day and the first day of a multiple dose regimen: Day 5/Day 1.

Analysis population: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.

Groups in this outcome

5 mcg/kg

Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

10 mcg/kg

Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

20 mcg/kg

Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

30 mcg/kg

Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

40 mcg/kg

Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

50 mcg/kg

Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

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

Analysis denominator · Participants

GroupSource count
5 mcg/kg2
10 mcg/kg3
20 mcg/kg2
30 mcg/kg2
40 mcg/kg4
50 mcg/kg11

Reported measurements

Source class 1
Values in ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
5 mcg/kg2.62Not reported1.224.02Not reported
10 mcg/kg3.08Not reported2.613.39Not reported
20 mcg/kg3.09Not reported0.03286.15Not reported
30 mcg/kg1.93Not reported1.202.66Not reported
40 mcg/kg12.4Not reported1.9925.0Not reported
50 mcg/kg3.63Not reported1.7321.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.22
        upper Limit
        4.02
        value
        2.62
      2. group Id
        OG001
        lower Limit
        2.61
        upper Limit
        3.39
        value
        3.08
      3. group Id
        OG002
        lower Limit
        0.0328
        upper Limit
        6.15
        value
        3.09
      4. group Id
        OG003
        lower Limit
        1.20
        upper Limit
        2.66
        value
        1.93
      5. group Id
        OG004
        lower Limit
        1.99
        upper Limit
        25.0
        value
        12.4
      6. group Id
        OG005
        lower Limit
        1.73
        upper Limit
        21.8
        value
        3.63
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      11
    units
    Participants
description
The AUC accumulation ratio of moxetumomab pasudotox was calculated as the geometric mean ratio of AUC(0-last) on the last day and the first day of a multiple dose regimen: Day 5/Day 1.
dispersion Type
Full Range
groups
  1. description
    Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    OG000
    title
    5 mcg/kg
  2. description
    Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    OG001
    title
    10 mcg/kg
  3. description
    Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    OG002
    title
    20 mcg/kg
  4. description
    Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    OG003
    title
    30 mcg/kg
  5. description
    Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    OG004
    title
    40 mcg/kg
  6. description
    Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    OG005
    title
    50 mcg/kg
param Type
MEDIAN
population Description
The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 and Day 5: pre-infusion, at 15 min during the infusion, at the end of infusion, and at 1, 1.5, 2, 4, 8, and 12 h post infusion
title
AUC Accumulation Ratio of Moxetumomab Pasudotox for Cycle 1
type
PRIMARY
unit Of Measure
ratio

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Preserved source evidence · Not medical advice