NCT00306202 · OUTCOME

Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) 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: GEOMETRIC_MEAN
Unit: ng/mL/mg/m^2
Interval / dispersion: Geometric Coefficient of Variation
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. Dose Normalized Cmax is the maximum observed concentration of drug substance in plasma normalized for different dasatinib dose levels.

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

Group	Source count
Dasatinib 60 mg/m^2 QD Starting Dose	53

Reported measurements

Infants and Toddlers (age<2 years old; n=2)

Values in ng/mL/mg/m^2 · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Dasatinib 60 mg/m^2 QD Starting Dose	1.0	15.2	Not reported	Not reported	Not reported

Children (age>=2 and <12 years old; n=43)

Values in ng/mL/mg/m^2 · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Dasatinib 60 mg/m^2 QD Starting Dose	1.9	79.9	Not reported	Not reported	Not reported

Adolescents (age>=12 and <18 years old; n=28)

Values in ng/mL/mg/m^2 · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Dasatinib 60 mg/m^2 QD Starting Dose	1.0	69.7	Not reported	Not reported	Not reported

Above 18 Years (n=1)

Values in ng/mL/mg/m^2 · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Dasatinib 60 mg/m^2 QD Starting Dose	0.9	NA	Not reported	Not reported	Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.

Total (n=74)

Values in ng/mL/mg/m^2 · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Dasatinib 60 mg/m^2 QD Starting Dose	1.5	86.9	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
15.2
value
1.0
title
Infants and Toddlers (age<2 years old; n=2)
categories
measurements
group Id
OG000
spread
79.9
value
1.9
title
Children (age>=2 and <12 years old; n=43)
categories
measurements
group Id
OG000
spread
69.7
value
1.0
title
Adolescents (age>=12 and <18 years old; n=28)
categories
measurements
comment
Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.
group Id
OG000
spread
NA
value
0.9
title
Above 18 Years (n=1)
categories
measurements
group Id
OG000
spread
86.9
value
1.5
title
Total (n=74)

denoms

counts
group Id
OG000
value
53
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

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

GEOMETRIC_MEAN

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 Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group

type

SECONDARY

unit Of Measure

ng/mL/mg/m^2

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Preserved source evidence · Not medical advice