TriangleNCT01956669 · OUTCOME
Observed Maximum Plasma Concentration (Cmax) of Pazopanib by Cohort
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
- Day 1 of Cycle 1 (0, 0.5, 1, 2, 4, 6 and 8 hours post-dose); Cycle 1 Day 15 ± 1 day (0, 0.5, 1, 2, 4, 6 and 8 hours post-dose)
What was measured
Cmax was calculated using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) and the LLOQ was 0.100 µg/mL. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.
Analysis population: PKES set
Groups in this outcome
Cohort 1: Rhabdomyosarcoma (RMS)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
Cohort 3: Ewing Sarcoma/pPNET (Ewing)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
Cohort 7 (Hepatoblastoma)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
| Group | Source count |
|---|---|
| Cohort 1: Rhabdomyosarcoma (RMS) | 4 |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | 3 |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 1 |
| Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) | 1 |
| Cohort 7 (Hepatoblastoma) | 5 |
Reported measurements
Cmax (C1D1)
| Group | Source count |
|---|---|
| Cohort 1: Rhabdomyosarcoma (RMS) | 4 |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | 3 |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 1 |
| Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) | 0 |
| Cohort 7 (Hepatoblastoma) | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Rhabdomyosarcoma (RMS) | 34.7 | 14.7 | Not reported | Not reported | Not reported |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | 35.6 | 75.9 | Not reported | Not reported | Not reported |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 0.0 | NA | Not reported | Not reported | NA: Not estimable due to insufficient number of participants with events |
| Cohort 7 (Hepatoblastoma) | 22.4 | 73.7 | Not reported | Not reported | Not reported |
Cmax (C1D15)
| Group | Source count |
|---|---|
| Cohort 1: Rhabdomyosarcoma (RMS) | 4 |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | 2 |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 1 |
| Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) | 1 |
| Cohort 7 (Hepatoblastoma) | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Rhabdomyosarcoma (RMS) | 56.7 | 53.3 | Not reported | Not reported | Not reported |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | 42.0 | 42.3 | Not reported | Not reported | Not reported |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 69.6 | NA | Not reported | Not reported | NA: Not estimable due to insufficient number of participants with events |
| Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) | 80.2 | NA | Not reported | Not reported | NA: Not estimable due to insufficient number of participants with events |
| Cohort 7 (Hepatoblastoma) | 33.4 | 95.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 14.7
- value
- 34.7
- group Id
- OG001
- spread
- 75.9
- value
- 35.6
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG002
- spread
- NA
- value
- 0.0
- group Id
- OG004
- spread
- 73.7
- value
- 22.4
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- Cmax (C1D1)
- categories
- measurements
- group Id
- OG000
- spread
- 53.3
- value
- 56.7
- group Id
- OG001
- spread
- 42.3
- value
- 42.0
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG002
- spread
- NA
- value
- 69.6
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG003
- spread
- NA
- value
- 80.2
- group Id
- OG004
- spread
- 95.9
- value
- 33.4
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- Cmax (C1D15)
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- description
- Cmax was calculated using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) and the LLOQ was 0.100 µg/mL. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG000
- title
- Cohort 1: Rhabdomyosarcoma (RMS)
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG001
- title
- Cohort 3: Ewing Sarcoma/pPNET (Ewing)
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG002
- title
- Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG003
- title
- Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG004
- title
- Cohort 7 (Hepatoblastoma)
- param Type
- GEOMETRIC_MEAN
- population Description
- PKES set
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 1 (0, 0.5, 1, 2, 4, 6 and 8 hours post-dose); Cycle 1 Day 15 ± 1 day (0, 0.5, 1, 2, 4, 6 and 8 hours post-dose)
- title
- Observed Maximum Plasma Concentration (Cmax) of Pazopanib by Cohort
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice