TriangleNCT00306202 · OUTCOME
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by 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/mg/m^2
- 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, normalized by dasatinib dose level.
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 QD Starting Dose
Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Strata 1, 2/3, and 4: 60 mg/m\^2 starting dose; 80 mg/m\^2 escalated/dose level 2; Stratum 4: 100 mg/m\^2 escalated/dose level 3 and 120 mg/m\^2 escalated/dose level 4. QD, as long as clinical benefit was observed.
| Group | Source count |
|---|---|
| Dasatinib 60 mg/m^2 QD Starting Dose | 53 |
Reported measurements
Infants and Toddlers (age<2 years old; n=2)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 QD Starting Dose | 2.8 | 4.6 | Not reported | Not reported | Not reported |
Children (age>=2 and <12 years old; n=40)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 QD Starting Dose | 6.1 | 95.7 | Not reported | Not reported | Not reported |
Adolescents (age>=12 and <18 years old; n=28)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 QD Starting Dose | 3.8 | 66.8 | Not reported | Not reported | Not reported |
Above 18 Years (n=1)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 QD Starting Dose | 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. |
Total (n=71)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 60 mg/m^2 QD Starting Dose | 4.9 | 98.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 4.6
- value
- 2.8
- title
- Infants and Toddlers (age<2 years old; n=2)
- categories
- measurements
- group Id
- OG000
- spread
- 95.7
- value
- 6.1
- title
- Children (age>=2 and <12 years old; n=40)
- categories
- measurements
- group Id
- OG000
- spread
- 66.8
- value
- 3.8
- title
- Adolescents (age>=12 and <18 years old; n=28)
- categories
- measurements
- comment
- Due to insufficient number of participants in this age group (only 1 participant), CV% could not be calculated.
- group Id
- OG000
- spread
- NA
- value
- 2.2
- title
- Above 18 Years (n=1)
- categories
- measurements
- group Id
- OG000
- spread
- 98.1
- value
- 4.9
- title
- Total (n=71)
- denoms
- counts
- group Id
- OG000
- value
- 53
- 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, normalized by dasatinib dose level.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Strata 1, 2/3, and 4: 60 mg/m\^2 starting dose; 80 mg/m\^2 escalated/dose level 2; Stratum 4: 100 mg/m\^2 escalated/dose level 3 and 120 mg/m\^2 escalated/dose level 4. QD, as long as clinical benefit was observed.
- id
- OG000
- title
- Dasatinib 60 mg/m^2 QD Starting Dose
- 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: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group
- type
- SECONDARY
- unit Of Measure
- ng.h/mL/mg/m^2
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Preserved source evidence · Not medical advice