TriangleNCT00306202 · OUTCOME
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng.h/mL
- 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. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.
Analysis population: All treated participants with plasma samples available. Each participant could have more than 1 plasma 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
Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
Dasatinib 80 mg/m^2
Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
Dasatinib 100 mg/m^2
Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.
Dasatinib 120 mg/m^2
Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.
| Group | Source count |
|---|---|
| Dasatinib 60 mg/m^2 | 19 |
| Dasatinib 80 mg/m^2 | 25 |
| Dasatinib 100 mg/m^2 | 18 |
| Dasatinib 120 mg/m^2 | 9 |
Reported measurements
Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | NA | NA | NA | NA | No participants in this age group. |
| Dasatinib 80 mg/m^2 | NA | NA | Not reported | Not reported | No participants in this age group. |
| Dasatinib 100 mg/m^2 | 100.8 | NA | Not reported | Not reported | Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated. |
| Dasatinib 120 mg/m^2 | 134.9 | NA | Not reported | Not reported | Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated. |
Children (age>=2 & <12yr; n=10; n=16; n=8; n=6)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 295.0 | 63.5 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 490.8 | 96.7 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 373.5 | 82.0 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 676.7 | 99.9 | Not reported | Not reported | Not reported |
Adolescents (age>=12 & <18yr; n=9; n=8; n=9; n=2)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 320.8 | 59.1 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 488.1 | 35.0 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 787.0 | 76.2 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 526.1 | 56.6 | Not reported | Not reported | Not reported |
Above 18 years (n=0; n=1; n=0; n=0)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | NA | NA | Not reported | Not reported | No participants in this age group. |
| Dasatinib 80 mg/m^2 | 367.2 | NA | Not reported | Not reported | Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated. |
| Dasatinib 100 mg/m^2 | NA | NA | Not reported | Not reported | No participants in this age group. |
| Dasatinib 120 mg/m^2 | NA | NA | Not reported | Not reported | No participants in this age group. |
Total
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 307.0 | 60.2 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 484.3 | 88.9 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 504.1 | 89.6 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 534.9 | 103.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- No participants in this age group.
- group Id
- OG000
- lower Limit
- NA
- spread
- NA
- upper Limit
- NA
- value
- NA
- comment
- No participants in this age group.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.
- group Id
- OG002
- spread
- NA
- value
- 100.8
- comment
- Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.
- group Id
- OG003
- spread
- NA
- value
- 134.9
- title
- Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1)
- categories
- measurements
- group Id
- OG000
- spread
- 63.5
- value
- 295.0
- group Id
- OG001
- spread
- 96.7
- value
- 490.8
- group Id
- OG002
- spread
- 82.0
- value
- 373.5
- group Id
- OG003
- spread
- 99.9
- value
- 676.7
- title
- Children (age>=2 & <12yr; n=10; n=16; n=8; n=6)
- categories
- measurements
- group Id
- OG000
- spread
- 59.1
- value
- 320.8
- group Id
- OG001
- spread
- 35.0
- value
- 488.1
- group Id
- OG002
- spread
- 76.2
- value
- 787.0
- group Id
- OG003
- spread
- 56.6
- value
- 526.1
- title
- Adolescents (age>=12 & <18yr; n=9; n=8; n=9; n=2)
- categories
- measurements
- comment
- No participants in this age group.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.
- group Id
- OG001
- spread
- NA
- value
- 367.2
- comment
- No participants in this age group.
- group Id
- OG002
- spread
- NA
- value
- NA
- comment
- No participants in this age group.
- group Id
- OG003
- spread
- NA
- value
- NA
- title
- Above 18 years (n=0; n=1; n=0; n=0)
- categories
- measurements
- group Id
- OG000
- spread
- 60.2
- value
- 307.0
- group Id
- OG001
- spread
- 88.9
- value
- 484.3
- group Id
- OG002
- spread
- 89.6
- value
- 504.1
- group Id
- OG003
- spread
- 103.9
- value
- 534.9
- title
- Total
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 9
- units
- Participants
- description
- PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG000
- title
- Dasatinib 60 mg/m^2
- description
- Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG001
- title
- Dasatinib 80 mg/m^2
- description
- Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG002
- title
- Dasatinib 100 mg/m^2
- description
- Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG003
- title
- Dasatinib 120 mg/m^2
- param Type
- GEOMETRIC_MEAN
- population Description
- All treated participants with plasma samples available. Each participant could have more than 1 plasma 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: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group
- type
- SECONDARY
- unit Of Measure
- ng.h/mL
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Preserved source evidence · Not medical advice