TriangleNCT01956669 · OUTCOME
Time to Reach Peak or Maximum Concentration (Tmax) of Pazopanib by Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Hours
- Interval / dispersion
- Full Range
- 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
Tmax 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
Tmax (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) | 1 | Not reported | 0.00 | 2.00 | Not reported |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | 2.02 | Not reported | 1.00 | 5.97 | Not reported |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 0.00 | Not reported | 0.00 | 0.00 | Not reported |
| Cohort 7 (Hepatoblastoma) | 2.00 | Not reported | 0.00 | 6.00 | Not reported |
Tmax (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) | 2.50 | Not reported | 2.00 | 3.03 | Not reported |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | 1.00 | Not reported | 1.00 | 1.00 | Not reported |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 3.47 | Not reported | 3.47 | 3.47 | Not reported |
| Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) | 3.03 | Not reported | 3.03 | 3.03 | Not reported |
| Cohort 7 (Hepatoblastoma) | 3.00 | Not reported | 0.98 | 4.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 2.00
- value
- 1
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 5.97
- value
- 2.02
- group Id
- OG002
- lower Limit
- 0.00
- upper Limit
- 0.00
- value
- 0.00
- group Id
- OG004
- lower Limit
- 0.00
- upper Limit
- 6.00
- value
- 2.00
- 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
- Tmax (C1D1)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.00
- upper Limit
- 3.03
- value
- 2.50
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 1.00
- value
- 1.00
- group Id
- OG002
- lower Limit
- 3.47
- upper Limit
- 3.47
- value
- 3.47
- group Id
- OG003
- lower Limit
- 3.03
- upper Limit
- 3.03
- value
- 3.03
- group Id
- OG004
- lower Limit
- 0.98
- upper Limit
- 4.00
- value
- 3.00
- 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
- Tmax (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
- Tmax 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
- Full Range
- 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
- MEDIAN
- 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
- Time to Reach Peak or Maximum Concentration (Tmax) of Pazopanib by Cohort
- type
- SECONDARY
- unit Of Measure
- Hours
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Preserved source evidence · Not medical advice