TriangleNCT00306202 · OUTCOME
Dasatinib Metabolite (BMS-582691) 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. n=number of PK parameters included. Each participant could have 1, 2, or 3 plasma PK 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 | 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 | NA | NA | Not reported | Not reported | No participants in this age group. |
| Dasatinib 120 mg/m^2 | 1.2 | 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=7; n=7)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 | 3.6 | 46.4 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 3.4 | 82.0 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 6.0 | 69.3 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 4.8 | 65.3 | Not reported | Not reported | 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 | 3.1 | 40.3 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 3.6 | 56.7 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 6.9 | 75.0 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 4.3 | 77.9 | 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 | 2.2 | 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 | 3.4 | 43.7 | Not reported | Not reported | Not reported |
| Dasatinib 80 mg/m^2 | 3.4 | 74.4 | Not reported | Not reported | Not reported |
| Dasatinib 100 mg/m^2 | 6.5 | 72.0 | Not reported | Not reported | Not reported |
| Dasatinib 120 mg/m^2 | 4.1 | 70.8 | 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
- No participants in this age group.
- group Id
- OG002
- 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
- OG003
- spread
- NA
- value
- 1.2
- title
- Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1)
- categories
- measurements
- group Id
- OG000
- spread
- 46.4
- value
- 3.6
- group Id
- OG001
- spread
- 82.0
- value
- 3.4
- group Id
- OG002
- spread
- 69.3
- value
- 6.0
- group Id
- OG003
- spread
- 65.3
- value
- 4.8
- title
- Children (age>=2 & <12yr; n=10; n=16; n=7; n=7)
- categories
- measurements
- group Id
- OG000
- spread
- 40.3
- value
- 3.1
- group Id
- OG001
- spread
- 56.7
- value
- 3.6
- group Id
- OG002
- spread
- 75.0
- value
- 6.9
- group Id
- OG003
- spread
- 77.9
- value
- 4.3
- 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
- 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
- 2.2
- 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
- 43.7
- value
- 3.4
- group Id
- OG001
- spread
- 74.4
- value
- 3.4
- group Id
- OG002
- spread
- 72.0
- value
- 6.5
- group Id
- OG003
- spread
- 70.8
- value
- 4.1
- 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. 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. n=number of PK parameters included. Each participant could have 1, 2, or 3 plasma PK 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 Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice