NCT02684058 · OUTCOME
AUCtau for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors · Source last updated 2023-12-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hr * ng/ml
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
What was measured
PK parameters were calculated by standard non-compartmental analysis. AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state
Analysis population: Participants who received at least one dose of dabrafenib with an evaluable AUCtau PK parameter
Groups in this outcome
HGG Cohort: Dabrafenib and Trametinib
Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
LGG Cohort: Dabrafenib and Trametinib
Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 34 |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 47 |
|---|
Reported measurements
Dabrafenib
Analysis denominator · Participants
| Group | Source count |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 34 |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 47 |
|---|
Values in hr * ng/ml · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 4300 | 44.7 | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 4910 | 54.0 | Not reported | Not reported | Not reported |
|---|
Carboxy-dabrafenib
Analysis denominator · Participants
| Group | Source count |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 29 |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 47 |
|---|
Values in hr * ng/ml · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 71200 | 34.0 | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 60700 | 45.7 | Not reported | Not reported | Not reported |
|---|
Desmethyl-dabrafenib
Analysis denominator · Participants
| Group | Source count |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 27 |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 44 |
|---|
Values in hr * ng/ml · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 3360 | 57.7 | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 3660 | 66.9 | Not reported | Not reported | Not reported |
|---|
Hydroxy-dabrafenib
Analysis denominator · Participants
| Group | Source count |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 33 |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 47 |
|---|
Values in hr * ng/ml · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 2840 | 35.7 | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 2960 | 47.4 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 44.7
- value
- 4300
- group Id
- OG001
- spread
- 54.0
- value
- 4910
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 47
- units
- Participants
- title
- Dabrafenib
- categories
- measurements
- group Id
- OG000
- spread
- 34.0
- value
- 71200
- group Id
- OG001
- spread
- 45.7
- value
- 60700
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 47
- units
- Participants
- title
- Carboxy-dabrafenib
- categories
- measurements
- group Id
- OG000
- spread
- 57.7
- value
- 3360
- group Id
- OG001
- spread
- 66.9
- value
- 3660
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 44
- units
- Participants
- title
- Desmethyl-dabrafenib
- categories
- measurements
- group Id
- OG000
- spread
- 35.7
- value
- 2840
- group Id
- OG001
- spread
- 47.4
- value
- 2960
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 47
- units
- Participants
- title
- Hydroxy-dabrafenib
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 47
- units
- Participants
- description
- PK parameters were calculated by standard non-compartmental analysis. AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
- id
- OG000
- title
- HGG Cohort: Dabrafenib and Trametinib
- description
- Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
- id
- OG001
- title
- LGG Cohort: Dabrafenib and Trametinib
- param Type
- GEOMETRIC_MEAN
- population Description
- Participants who received at least one dose of dabrafenib with an evaluable AUCtau PK parameter
- reporting Status
- POSTED
- time Frame
- Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
- title
- AUCtau for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
- type
- SECONDARY
- unit Of Measure
- hr * ng/ml
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Preserved source evidence · Not medical advice
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