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NCT01956669 · OUTCOME

Area Under the Plasma Concentration-time Curve Calculated From Time 0 to 8 h Postdose (AUC0-8h) and Calculated to the Last Quantifiable Concentration Point (AUClast) of Pazopanib 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
GEOMETRIC_MEAN
Unit
ng*hr/mL
Interval / dispersion
Geometric Coefficient of Variation
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

AUC0-8h and AUClast were 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 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)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

AUC0-8h (C1D1)

Analysis denominator · Participants

GroupSource count
Cohort 1: Rhabdomyosarcoma (RMS)2
Cohort 3: Ewing Sarcoma/pPNET (Ewing)2
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)0
Cohort 7 (Hepatoblastoma)3
Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1: Rhabdomyosarcoma (RMS)19519.0Not reportedNot reportedNot reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)21493.2Not reportedNot reportedNot reported
Cohort 7 (Hepatoblastoma)13560.2Not reportedNot reportedNot reported
AUC0-8h (C1D15)

Analysis denominator · Participants

GroupSource 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
Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1: Rhabdomyosarcoma (RMS)38855.9Not reportedNot reportedNot reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)26636.1Not reportedNot reportedNot reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)475NANot reportedNot reportedNA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)566NANot reportedNot reportedNA: Not estimable due to insufficient number of participants with events
Cohort 7 (Hepatoblastoma)22989.5Not reportedNot reportedNot reported
AUClast (C1D1)

Analysis denominator · Participants

GroupSource count
Cohort 1: Rhabdomyosarcoma (RMS)2
Cohort 3: Ewing Sarcoma/pPNET (Ewing)3
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)0
Cohort 7 (Hepatoblastoma)5
Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1: Rhabdomyosarcoma (RMS)19419.6Not reportedNot reportedNot reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)18965.8Not reportedNot reportedNot reported
Cohort 7 (Hepatoblastoma)13560.2Not reportedNot reportedNot reported
AUClast (C1D15)

Analysis denominator · Participants

GroupSource 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
Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1: Rhabdomyosarcoma (RMS)96658.1Not reportedNot reportedNot reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)63335.4Not reportedNot reportedNot reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)1230NANot reportedNot reportedNA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)1490NANot reportedNot reportedNA: Not estimable due to insufficient number of participants with events
Cohort 7 (Hepatoblastoma)60785.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.0
        value
        195
      2. group Id
        OG001
        spread
        93.2
        value
        214
      3. group Id
        OG004
        spread
        60.2
        value
        135
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        3
      units
      Participants
    title
    AUC0-8h (C1D1)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.9
        value
        388
      2. group Id
        OG001
        spread
        36.1
        value
        266
      3. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG002
        spread
        NA
        value
        475
      4. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG003
        spread
        NA
        value
        566
      5. group Id
        OG004
        spread
        89.5
        value
        229
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        5
      units
      Participants
    title
    AUC0-8h (C1D15)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.6
        value
        194
      2. group Id
        OG001
        spread
        65.8
        value
        189
      3. group Id
        OG004
        spread
        60.2
        value
        135
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        5
      units
      Participants
    title
    AUClast (C1D1)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        58.1
        value
        966
      2. group Id
        OG001
        spread
        35.4
        value
        633
      3. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG002
        spread
        NA
        value
        1230
      4. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG003
        spread
        NA
        value
        1490
      5. group Id
        OG004
        spread
        85.0
        value
        607
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        5
      units
      Participants
    title
    AUClast (C1D15)
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      5
    units
    Participants
description
AUC0-8h and AUClast were 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
Geometric Coefficient of Variation
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 3: Ewing Sarcoma/pPNET (Ewing)
  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 5: Measurable Neuroblastoma (mNeuroblastoma)
  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 6: Evaluable Neuroblastoma (eNeuroblastma)
  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 7 (Hepatoblastoma)
param Type
GEOMETRIC_MEAN
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
Area Under the Plasma Concentration-time Curve Calculated From Time 0 to 8 h Postdose (AUC0-8h) and Calculated to the Last Quantifiable Concentration Point (AUClast) of Pazopanib by Cohort
type
SECONDARY
unit Of Measure
ng*hr/mL

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Preserved source evidence · Not medical advice