TriangleNCT00306202 · OUTCOME
Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) 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/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. Cmax is the maximum observed concentration of drug substance in plasma.
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
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 | 20 |
| Dasatinib 80 mg/m^2 | 25 |
| Dasatinib 100 mg/m^2 | 19 |
| Dasatinib 120 mg/m^2 | 10 |
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 | Not reported | Not reported | 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 | 30.6 | 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 | 53.8 | 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=11; n=16; n=9; n=7)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 110.6 | 61.8 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 142.5 | 80.2 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 111.2 | 82.6 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 208.4 | 78.5 | Not reported | Not reported | Not reported |
Adolescents (age>=12; n=9; n=8; n=9; n=2)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 92.6 | 50.6 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 116.5 | 73.0 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 235.1 | 59.0 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 123.3 | 68.3 | 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 | 143.2 | 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 | 102.1 | 58.0 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 133.6 | 77.6 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 148.1 | 75.0 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 163.9 | 87.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- No participants in this age group.
- group Id
- OG000
- spread
- 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
- 30.6
- 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
- 53.8
- title
- Infants and Toddlers (age>2yr; n=0; n=0; n=1; n=1)
- categories
- measurements
- group Id
- OG000
- spread
- 61.8
- value
- 110.6
- group Id
- OG001
- spread
- 80.2
- value
- 142.5
- group Id
- OG002
- spread
- 82.6
- value
- 111.2
- group Id
- OG003
- spread
- 78.5
- value
- 208.4
- title
- Children (age>=2 & <12yr; n=11; n=16; n=9; n=7)
- categories
- measurements
- group Id
- OG000
- spread
- 50.6
- value
- 92.6
- group Id
- OG001
- spread
- 73.0
- value
- 116.5
- group Id
- OG002
- spread
- 59.0
- value
- 235.1
- group Id
- OG003
- spread
- 68.3
- value
- 123.3
- title
- Adolescents (age>=12; 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
- 143.2
- 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
- 58.0
- value
- 102.1
- group Id
- OG001
- spread
- 77.6
- value
- 133.6
- group Id
- OG002
- spread
- 75.0
- value
- 148.1
- group Id
- OG003
- spread
- 87.6
- value
- 163.9
- title
- Total
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 10
- units
- Participants
- description
- PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.
- 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 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: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice