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NCT00306202 · OUTCOME

Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group

Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia · Source last updated 2021-02-26

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
During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).

What was measured

PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.

Analysis population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.

Groups in this outcome

Dasatinib 60 mg/m^2 QD Starting Dose

Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Strata 1, 2/3, and 4: 60 mg/m\^2 starting dose; 80 mg/m\^2 escalated/dose level 2; Stratum 4: 100 mg/m\^2 escalated/dose level 3 and 120 mg/m\^2 escalated/dose level 4. QD, as long as clinical benefit was observed.

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

Analysis denominator · Participants

GroupSource count
Dasatinib 60 mg/m^2 QD Starting Dose53

Reported measurements

Infants and Toddlers (age<2 years old; n=2)
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dasatinib 60 mg/m^2 QD Starting Dose0.50.00.50.5Not reported
Children (age>=2 and <12 years old; n=43)
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dasatinib 60 mg/m^2 QD Starting Dose1.158.60.54.1Not reported
Adolescents (age>=12 and <18 years old; n=28)
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dasatinib 60 mg/m^2 QD Starting Dose1.082.20.56.0Not reported
Above 18 Years (n=1)
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dasatinib 60 mg/m^2 QD Starting Dose0.9NA0.90.9Not reported
Total (n=74)
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dasatinib 60 mg/m^2 QD Starting Dose1.070.90.56.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        spread
        0.0
        upper Limit
        0.5
        value
        0.5
    title
    Infants and Toddlers (age<2 years old; n=2)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        spread
        58.6
        upper Limit
        4.1
        value
        1.1
    title
    Children (age>=2 and <12 years old; n=43)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        spread
        82.2
        upper Limit
        6.0
        value
        1.0
    title
    Adolescents (age>=12 and <18 years old; n=28)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        spread
        NA
        upper Limit
        0.9
        value
        0.9
    title
    Above 18 Years (n=1)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        spread
        70.9
        upper Limit
        6.0
        value
        1.0
    title
    Total (n=74)
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    units
    Participants
description
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.
dispersion Type
Full Range
groups
  1. description
    Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Strata 1, 2/3, and 4: 60 mg/m\^2 starting dose; 80 mg/m\^2 escalated/dose level 2; Stratum 4: 100 mg/m\^2 escalated/dose level 3 and 120 mg/m\^2 escalated/dose level 4. QD, as long as clinical benefit was observed.
    id
    OG000
    title
    Dasatinib 60 mg/m^2 QD Starting Dose
param Type
MEDIAN
population Description
All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.
reporting Status
POSTED
time Frame
During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
title
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice