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NCT00586924 · OUTCOME

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox for Cycle 1 on Day 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
hours
Interval / dispersion
Full Range
Time frame
Cycle 1 Day 1: pre-infusion; at 15 minutes (min) during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 hours (h) post infusion

What was measured

The Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox.

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 hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
5 mcg/kg0.508Not reported0.3830.633Not reported
10 mcg/kg0.467Not reported0.4500.483Not reported
20 mcg/kg0.367Not reported0.2330.500Not reported
30 mcg/kg0.467Not reported0.4170.517Not reported
40 mcg/kg0.267Not reported0.2500.417Not reported
50 mcg/kg0.417Not reported0.2500.500Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.383
        upper Limit
        0.633
        value
        0.508
      2. group Id
        OG001
        lower Limit
        0.450
        upper Limit
        0.483
        value
        0.467
      3. group Id
        OG002
        lower Limit
        0.233
        upper Limit
        0.500
        value
        0.367
      4. group Id
        OG003
        lower Limit
        0.417
        upper Limit
        0.517
        value
        0.467
      5. group Id
        OG004
        lower Limit
        0.250
        upper Limit
        0.417
        value
        0.267
      6. group Id
        OG005
        lower Limit
        0.250
        upper Limit
        0.500
        value
        0.417
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 Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox.
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: pre-infusion; at 15 minutes (min) during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 hours (h) post infusion
title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox for Cycle 1 on Day 1
type
PRIMARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice