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NCT01956669 · OUTCOME

Duration of Response (DOR) by Cohort

Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors · Source last updated 2020-08-12

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

DoR was defined as the time from initial response to the first documented disease progression or death due to any cause, and was determined only for those participants from the mITT population with a confirmed response (CR or PR). 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource 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
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: Rhabdomyosarcoma (RMS)NANot reportedNANANA: Not estimable due to insufficient number of participants with events
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)NANot reportedNANANA: Not estimable due to insufficient number of participants with events
Cohort 3: Ewing Sarcoma/pPNET (Ewing)NANot reportedNANANA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)NANot reportedNANANA: Not estimable due to insufficient number of participants with events
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)NANot reportedNANANA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)NANot reportedNANANA: Not estimable due to insufficient number of participants with events
Cohort 7 (Hepatoblastoma)NANot reportedNANANA: Not estimable due to insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      5. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      6. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      7. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG006
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      6
    units
    Participants
description
DoR was defined as the time from initial response to the first documented disease progression or death due to any cause, and was determined only for those participants from the mITT population with a confirmed response (CR or PR). Only descriptive analysis performed.
dispersion Type
90% Confidence Interval
groups
  1. 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)
  2. 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)
  3. 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)
  4. 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)
  5. 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)
  6. 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)
  7. 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
Duration of Response (DOR) by Cohort
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice