TriangleNCT00306202 · OUTCOME
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) 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
- MEDIAN
- Unit
- hour
- 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. n=number of PK parameters included. Each participant could have more than 1 plasma 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 | 18 |
| Dasatinib 80 mg/m^2 | 25 |
| Dasatinib 100 mg/m^2 | 16 |
| Dasatinib 120 mg/m^2 | 10 |
Reported measurements
Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | NA | Not reported | NA | NA | No participants in this age group. |
| Dasatinib 80 mg/m^2 | NA | Not reported | NA | NA | No participants in this age group. |
| Dasatinib 100 mg/m^2 | NA | Not reported | NA | NA | No participants in this age group. |
| Dasatinib 120 mg/m^2 | 0.9 | Not reported | 0.9 | 0.9 | Not reported |
Children (age>=2 & <12yr; n=10; n=16; n=7; n=7)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 2.0 | Not reported | 1.0 | 4.5 | Not reported |
| Dasatinib 80 mg/m^2 | 2.0 | Not reported | 0.5 | 6.0 | Not reported |
| Dasatinib 100 mg/m^2 | 2.1 | Not reported | 1.0 | 4.1 | Not reported |
| Dasatinib 120 mg/m^2 | 2.0 | Not reported | 1.0 | 2.2 | Not reported |
Adolescents (age>=12 & <18yr ; n=8; n=8; n=9; n=2)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 2.0 | Not reported | 1.0 | 4.0 | Not reported |
| Dasatinib 80 mg/m^2 | 2.0 | Not reported | 1.0 | 4.0 | Not reported |
| Dasatinib 100 mg/m^2 | 2.0 | Not reported | 1.0 | 8.1 | Not reported |
| Dasatinib 120 mg/m^2 | 2.1 | Not reported | 2.0 | 2.1 | 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 | Not reported | NA | NA | No participants in this age group. |
| Dasatinib 80 mg/m^2 | 0.9 | Not reported | 0.9 | 0.9 | Not reported |
| Dasatinib 100 mg/m^2 | NA | Not reported | NA | NA | No participants in this age group. |
| Dasatinib 120 mg/m^2 | NA | Not reported | NA | NA | No participants in this age group. |
Total
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 2.0 | Not reported | 1.0 | 4.5 | Not reported |
| Dasatinib 80 mg/m^2 | 2.0 | Not reported | 0.5 | 6.0 | Not reported |
| Dasatinib 100 mg/m^2 | 2.0 | Not reported | 1.0 | 8.1 | Not reported |
| Dasatinib 120 mg/m^2 | 2.0 | Not reported | 0.9 | 2.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- No participants in this age group.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- No participants in this age group.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- No participants in this age group.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG003
- lower Limit
- 0.9
- upper Limit
- 0.9
- value
- 0.9
- title
- Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 4.5
- value
- 2.0
- group Id
- OG001
- lower Limit
- 0.5
- upper Limit
- 6.0
- value
- 2.0
- group Id
- OG002
- lower Limit
- 1.0
- upper Limit
- 4.1
- value
- 2.1
- group Id
- OG003
- lower Limit
- 1.0
- upper Limit
- 2.2
- value
- 2.0
- title
- Children (age>=2 & <12yr; n=10; n=16; n=7; n=7)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 4.0
- value
- 2.0
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 4.0
- value
- 2.0
- group Id
- OG002
- lower Limit
- 1.0
- upper Limit
- 8.1
- value
- 2.0
- group Id
- OG003
- lower Limit
- 2.0
- upper Limit
- 2.1
- value
- 2.1
- title
- Adolescents (age>=12 & <18yr ; n=8; n=8; n=9; n=2)
- categories
- measurements
- comment
- No participants in this age group.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 0.9
- upper Limit
- 0.9
- value
- 0.9
- comment
- No participants in this age group.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- No participants in this age group.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Above 18 years (n=0; n=1; n=0; n=0)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 4.5
- value
- 2.0
- group Id
- OG001
- lower Limit
- 0.5
- upper Limit
- 6.0
- value
- 2.0
- group Id
- OG002
- lower Limit
- 1.0
- upper Limit
- 8.1
- value
- 2.0
- group Id
- OG003
- lower Limit
- 0.9
- upper Limit
- 2.2
- value
- 2.0
- title
- Total
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 16
- 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. Tmax is the time taken to reach the maximum observed plasma concentration.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.
- 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 Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group
- type
- SECONDARY
- unit Of Measure
- hour
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Preserved source evidence · Not medical advice