TriangleNCT01956669 · OUTCOME
Percentage of Participants Achieving Clinical Benefit Rate (CBR) by Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From date of first dose of study treatment up to 55 months
What was measured
CBR was defined as the percentage of participants achieving either a confirmed complete response (CR) or confirmed partial response (PR) or Stable Disease (SD) for at least two protocol scheduled disease assessments based on RECIST1.1. CR, disappearance of all target and non-target lesions; PR, at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study enrollment, also no new lesion or progression of any non-target measurable lesion; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Only descriptive analysis performed.
Analysis population: mITT 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 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)
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 4 (Osteosarcoma)
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) | 12 |
| Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS) | 11 |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | 10 |
| Cohort 4 (Osteosarcoma) | 10 |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 4 |
| Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) | 4 |
| Cohort 7 (Hepatoblastoma) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Rhabdomyosarcoma (RMS) | 8.3 | Not reported | 0.4 | 33.9 | Not reported |
| Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS) | 27.3 | Not reported | 7.9 | 56.4 | Not reported |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | 20.0 | Not reported | 3.7 | 50.7 | Not reported |
| Cohort 4 (Osteosarcoma) | 20.0 | Not reported | 3.7 | 50.7 | Not reported |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 50.0 | Not reported | 9.8 | 90.2 | Not reported |
| Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) | 25.0 | Not reported | 1.3 | 75.1 | Not reported |
| Cohort 7 (Hepatoblastoma) | 0.0 | Not reported | 0.0 | 39.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.4
- upper Limit
- 33.9
- value
- 8.3
- group Id
- OG001
- lower Limit
- 7.9
- upper Limit
- 56.4
- value
- 27.3
- group Id
- OG002
- lower Limit
- 3.7
- upper Limit
- 50.7
- value
- 20.0
- group Id
- OG003
- lower Limit
- 3.7
- upper Limit
- 50.7
- value
- 20.0
- group Id
- OG004
- lower Limit
- 9.8
- upper Limit
- 90.2
- value
- 50.0
- group Id
- OG005
- lower Limit
- 1.3
- upper Limit
- 75.1
- value
- 25.0
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 39.3
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 6
- units
- Participants
- description
- CBR was defined as the percentage of participants achieving either a confirmed complete response (CR) or confirmed partial response (PR) or Stable Disease (SD) for at least two protocol scheduled disease assessments based on RECIST1.1. CR, disappearance of all target and non-target lesions; PR, at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study enrollment, also no new lesion or progression of any non-target measurable lesion; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Only descriptive analysis performed.
- dispersion Type
- 90% Confidence Interval
- 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 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)
- 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 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
- OG003
- title
- Cohort 4 (Osteosarcoma)
- 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 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
- OG005
- 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
- OG006
- title
- Cohort 7 (Hepatoblastoma)
- param Type
- NUMBER
- population Description
- mITT set
- reporting Status
- POSTED
- time Frame
- From date of first dose of study treatment up to 55 months
- title
- Percentage of Participants Achieving Clinical Benefit Rate (CBR) by Cohort
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice