TriangleNCT00306202 · OUTCOME
Concentration of Dasatinib in Cerebrospinal Fluid (CSF) 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
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- 4 hours after oral dose
What was measured
Concentration of dasatinib in CSF was assessed only in participants who had lumbar puncture during the treatment. y=years
Analysis population: All treated participants with CSF samples available. n=number of PK parameters included. Each participant could have more than 1 CSF profiles sampled, depending on the number of times the dose of dasatinib was escalated.
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 | 4 |
| Dasatinib 80 mg/m^2 | 10 |
| Dasatinib 100 mg/m^2 | 6 |
| Dasatinib 120 mg/m^2 | 1 |
Reported measurements
Children (age>=2 & <12 y; n=3, n=9, n=3, n=1)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 1.1 | 0.2 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 1.5 | 0.6 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 1.7 | 0.4 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 3.8 | NA | Not reported | Not reported | Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated. |
Adolescents (age>=12 & <18 y; n=1; n=1; n=3; n=0)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 1.1 | NA | Not reported | Not reported | Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated. |
| Dasatinib 80 mg/m^2 | 1.0 | NA | Not reported | Not reported | Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated. |
| Dasatinib 100 mg/m^2 | 2.6 | 0.6 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | NA | NA | Not reported | Not reported | No participants in this age group. |
Total (Children + Adolescents;n=4; n=10; n=6; n=1)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 1.1 | 0.1 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 1.4 | 0.6 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 2.1 | 0.7 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 3.8 | NA | Not reported | Not reported | Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.2
- value
- 1.1
- group Id
- OG001
- spread
- 0.6
- value
- 1.5
- group Id
- OG002
- spread
- 0.4
- value
- 1.7
- comment
- Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated.
- group Id
- OG003
- spread
- NA
- value
- 3.8
- title
- Children (age>=2 & <12 y; n=3, n=9, n=3, n=1)
- categories
- measurements
- comment
- Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated.
- group Id
- OG000
- spread
- NA
- value
- 1.1
- comment
- Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated.
- group Id
- OG001
- spread
- NA
- value
- 1.0
- group Id
- OG002
- spread
- 0.6
- value
- 2.6
- comment
- No participants in this age group.
- group Id
- OG003
- spread
- NA
- value
- NA
- title
- Adolescents (age>=12 & <18 y; n=1; n=1; n=3; n=0)
- categories
- measurements
- group Id
- OG000
- spread
- 0.1
- value
- 1.1
- group Id
- OG001
- spread
- 0.6
- value
- 1.4
- group Id
- OG002
- spread
- 0.7
- value
- 2.1
- comment
- Due to insufficient number of participants in this age group (only 1 participant), standard deviation could not be calculated.
- group Id
- OG003
- spread
- NA
- value
- 3.8
- title
- Total (Children + Adolescents;n=4; n=10; n=6; n=1)
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- Concentration of dasatinib in CSF was assessed only in participants who had lumbar puncture during the treatment. y=years
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- All treated participants with CSF samples available. n=number of PK parameters included. Each participant could have more than 1 CSF profiles sampled, depending on the number of times the dose of dasatinib was escalated.
- reporting Status
- POSTED
- time Frame
- 4 hours after oral dose
- title
- Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice