TriangleNCT01956669 · OUTCOME
Percentage of Participants Achieving Objective Response Rate (ORR) in Subjects' With Tumors of Secondary Interest (Osteosarcoma, mNeuroblastoma, eNeuroblastoma or Hepatoblastoma)
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
ORR was defined as the percentage of participants achieving either a Complete Response (CR) or partial Response (PR) based on the Investigator review. For solid tumors with measurable diseases, such as osteosarcoma, the responses was 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. For neuroblastoma with bone marrow response, morphology was determined by hematoxylin and eosin staining of the marrow and aspirates. For neuroblastoma MIBG+ only, the responses was assessed using Curie scale for lesion scoring; For hepatoblastoma, assessment may have included the serum AFP response, in addition to the RECIST1.1 methodology. Only descriptive analysis performed.
Analysis population: mITT set
Groups in this outcome
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 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 4 (Osteosarcoma) | 0.0 | Not reported | 0.0 | 25.9 | Not reported |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 0.0 | Not reported | 0.0 | 52.7 | Not reported |
| Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) | 0.0 | Not reported | 0.0 | 52.7 | 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
- 0.0
- upper Limit
- 25.9
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 52.7
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 52.7
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 39.3
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- ORR was defined as the percentage of participants achieving either a Complete Response (CR) or partial Response (PR) based on the Investigator review. For solid tumors with measurable diseases, such as osteosarcoma, the responses was 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. For neuroblastoma with bone marrow response, morphology was determined by hematoxylin and eosin staining of the marrow and aspirates. For neuroblastoma MIBG+ only, the responses was assessed using Curie scale for lesion scoring; For hepatoblastoma, assessment may have included the serum AFP response, in addition to the RECIST1.1 methodology. 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 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
- OG001
- 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
- OG002
- 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
- OG003
- 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 Objective Response Rate (ORR) in Subjects' With Tumors of Secondary Interest (Osteosarcoma, mNeuroblastoma, eNeuroblastoma or Hepatoblastoma)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice