TriangleNCT02124772 · OUTCOME
Average Steady State Plasma Concentration (Cavg) of Trametinib When Administered Alone (Monotherapy)
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
- pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.
What was measured
Pharmacokinetic (PK) parameters were calculated based on trametinib plasma concentrations by using non-compartmental methods. The average steady state plasma concentration (Cavg) of trametinib was calculated as the ratio of area under the curve (AUC)/tau, where tau = 24 h for trametinib.
Analysis population: All subjects who received at least one dose of trametinib in Part A and B and provided an evaluable PK profile with a value for the outcome measure
Groups in this outcome
Part A - TMT 0.0125 mg/kg/Day
Participants treated with trametinib 0.0125 mg/kg/day
Part A - TMT 0.025 mg/kg/Day
Participants treated with trametinib 0.025 mg/kg/day
Part A - TMT 0.032 mg/kg/Day
Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
Part A - TMT 0.04 mg/kg/Day
Participants treated with trametinib 0.04 mg/kg/day
Part B - Neuroblastoma
Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
Part B - LGG Fusion
Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
Part B - NF-1 With PN
Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
Part B - BRAF V600 Mutant Solid Tumor
Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
Part B - All Tumor Types TMT 0.025 mg/kg/Day
Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day
| Group | Source count |
|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 3 |
| Part A - TMT 0.025 mg/kg/Day | 18 |
| Part A - TMT 0.032 mg/kg/Day | 9 |
| Part A - TMT 0.04 mg/kg/Day | 15 |
| Part B - Neuroblastoma | 9 |
| Part B - LGG Fusion | 10 |
| Part B - NF-1 With PN | 10 |
| Part B - BRAF V600 Mutant Solid Tumor | 9 |
| Part B - All Tumor Types TMT 0.025 mg/kg/Day | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 5.76 | 24.8 | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 13.9 | 27.1 | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 15.2 | 16.9 | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 21.3 | 20.7 | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 15.1 | 36.0 | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 13.2 | 40.4 | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 13.5 | 25.1 | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 15.8 | 42.8 | Not reported | Not reported | Not reported |
| Part B - All Tumor Types TMT 0.025 mg/kg/Day | 14.3 | 35.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 24.8
- value
- 5.76
- group Id
- OG001
- spread
- 27.1
- value
- 13.9
- group Id
- OG002
- spread
- 16.9
- value
- 15.2
- group Id
- OG003
- spread
- 20.7
- value
- 21.3
- group Id
- OG004
- spread
- 36.0
- value
- 15.1
- group Id
- OG005
- spread
- 40.4
- value
- 13.2
- group Id
- OG006
- spread
- 25.1
- value
- 13.5
- group Id
- OG007
- spread
- 42.8
- value
- 15.8
- group Id
- OG008
- spread
- 35.8
- value
- 14.3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 38
- units
- Participants
- description
- Pharmacokinetic (PK) parameters were calculated based on trametinib plasma concentrations by using non-compartmental methods. The average steady state plasma concentration (Cavg) of trametinib was calculated as the ratio of area under the curve (AUC)/tau, where tau = 24 h for trametinib.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants treated with trametinib 0.0125 mg/kg/day
- id
- OG000
- title
- Part A - TMT 0.0125 mg/kg/Day
- description
- Participants treated with trametinib 0.025 mg/kg/day
- id
- OG001
- title
- Part A - TMT 0.025 mg/kg/Day
- description
- Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
- id
- OG002
- title
- Part A - TMT 0.032 mg/kg/Day
- description
- Participants treated with trametinib 0.04 mg/kg/day
- id
- OG003
- title
- Part A - TMT 0.04 mg/kg/Day
- description
- Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
- id
- OG004
- title
- Part B - Neuroblastoma
- description
- Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
- id
- OG005
- title
- Part B - LGG Fusion
- description
- Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
- id
- OG006
- title
- Part B - NF-1 With PN
- description
- Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
- id
- OG007
- title
- Part B - BRAF V600 Mutant Solid Tumor
- description
- Participants (all tumor types in Part B) treated with trametinib 0.025 mg/kg/day
- id
- OG008
- title
- Part B - All Tumor Types TMT 0.025 mg/kg/Day
- param Type
- GEOMETRIC_MEAN
- population Description
- All subjects who received at least one dose of trametinib in Part A and B and provided an evaluable PK profile with a value for the outcome measure
- reporting Status
- POSTED
- time Frame
- pre dose, 1, 2, 4, 7, 10 and 24 hours post trametinib dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.
- title
- Average Steady State Plasma Concentration (Cavg) of Trametinib When Administered Alone (Monotherapy)
- type
- PRIMARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice