TriangleNCT01956669 · OUTCOME
Progression Free Survival (PFS) as Assessed by the Investigator by Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From date of first dose of study treatment up to 59 months
What was measured
PFS was defined as the interval between the date of first dose of study medication and the earliest date of disease progression or death due to any cause. Disease progression was based on radiographic evidence, and assessments made by the investigator. According to RECIST1.1, disease progression was defined as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions. For participants who did not progress or die, PFS was censored at the date of last adequate assessment or date of last adequate assessment prior to initiation of new anti-cancer therapy. 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) | 1.8 | Not reported | 1.0 | 1.8 | Not reported |
| Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS) | 1.8 | Not reported | 0.3 | 13.8 | Not reported |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | 2.3 | Not reported | 0.2 | 13.5 | Not reported |
| Cohort 4 (Osteosarcoma) | 1.9 | Not reported | 0.5 | 5.3 | Not reported |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 4.9 | Not reported | 0.8 | 6.4 | Not reported |
| Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) | 5.4 | Not reported | 3.6 | 24.4 | Not reported |
| Cohort 7 (Hepatoblastoma) | 1.8 | Not reported | 0.5 | 1.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 1.8
- value
- 1.8
- group Id
- OG001
- lower Limit
- 0.3
- upper Limit
- 13.8
- value
- 1.8
- group Id
- OG002
- lower Limit
- 0.2
- upper Limit
- 13.5
- value
- 2.3
- group Id
- OG003
- lower Limit
- 0.5
- upper Limit
- 5.3
- value
- 1.9
- group Id
- OG004
- lower Limit
- 0.8
- upper Limit
- 6.4
- value
- 4.9
- group Id
- OG005
- lower Limit
- 3.6
- upper Limit
- 24.4
- value
- 5.4
- group Id
- OG006
- lower Limit
- 0.5
- upper Limit
- 1.9
- value
- 1.8
- 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
- PFS was defined as the interval between the date of first dose of study medication and the earliest date of disease progression or death due to any cause. Disease progression was based on radiographic evidence, and assessments made by the investigator. According to RECIST1.1, disease progression was defined as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions. For participants who did not progress or die, PFS was censored at the date of last adequate assessment or date of last adequate assessment prior to initiation of new anti-cancer therapy. 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
- MEDIAN
- population Description
- mITT set
- reporting Status
- POSTED
- time Frame
- From date of first dose of study treatment up to 59 months
- title
- Progression Free Survival (PFS) as Assessed by the Investigator by Cohort
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice