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NCT01956669 · OUTCOME

Summary for Change From Baseline Levels of Plasma Biomarkers by High and Low Pazopanib Steady State Trough Concentration and 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: MEAN
Unit: picogram/milliliter (pg/mL)
Interval / dispersion: Standard Deviation
Time frame: predose Cycle 1 Day 1, Cycle 2 Day 1

What was measured

Participants with steady state trough concentration median levels for the following biomarker parameters (proto-oncogene c-KIT (c-KIT), Fibroblast growth factor (FGF), Placental growth factor PGF), Angiopoietin-1 receptor (TIE2), Vascular endothelial growth factor A (VEGF-A), Vascular endothelial growth factor C (VEGF-C), Vascular endothelial growth factor D (VEGF-D), Vascular endothelial growth factor receptor 1 (VEGFR-1) and Vascular endothelial growth factor receptor 2 (VEGFR-2)) above the median levels were classified as high or below median levels were classified as low. Only descriptive analysis performed.

Analysis population: Biomarker set. Only patient with steady state trough plasma Pazopanib concentration included in the analysis.

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

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	12
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	11
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	9
Cohort 4 (Osteosarcoma)	9
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	3
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	4
Cohort 7 (Hepatoblastoma)	3

Reported measurements

c-KIT high trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	0
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	1
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	-76081.1	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	-40512.6	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	-51199.4	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

c-KIT low trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	1
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	1
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	0
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	-13480.5	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	-44973.7	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	-48764.1	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	-35678.6	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

FGF high trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	0
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	1
Cohort 4 (Osteosarcoma)	0
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	0
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	-7.0	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

FGF low trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	0
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	0
Cohort 4 (Osteosarcoma)	0
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	0
Cohort 7 (Hepatoblastoma)	0

PGF high trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	0
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	1
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	78.3	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	15.6	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	45.4	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

PGF low trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	1
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	0
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	0
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	5.6	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	28.3	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

TIE2 high trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	0
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	1
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	2553.0	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	-509.4	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	-2708.2	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

TIE2 low trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	1
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	1
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	0
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	1212.4	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	-1514.9	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	-918.4	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	-473.0	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGF-A high trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	0
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	1
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	358.8	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	34.3	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	-73.3	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGF-A low trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	1
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	1
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	0
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	2436.6	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	18.5	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	52.3	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	39.7	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGF-C high trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	0
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	0
Cohort 4 (Osteosarcoma)	0
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	0
Cohort 7 (Hepatoblastoma)	0

VEGF-C low trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	0
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	0
Cohort 4 (Osteosarcoma)	0
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	0
Cohort 7 (Hepatoblastoma)	0

VEGF-D high trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	0
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	1
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	88.0	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	139.7	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	187.5	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGF-D low trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	1
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	1
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	0
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	423.2	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	44.1	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	153.5	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	90.8	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGFR-1 high trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	0
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	1
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	-217.5	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	955.6	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	-49.7	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGFR-1 low trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	1
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	1
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	0
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	484.1	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	-67.2	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	-7.7	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	-741.3	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGFR-2 high trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	0
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	0
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	1
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	-2620.0	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	-16136.9	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	-16838.7	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGFR-2 low trough concentration

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	1
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	1
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	0
Cohort 4 (Osteosarcoma)	1
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	0
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1
Cohort 7 (Hepatoblastoma)	0

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	-12130.8	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	-7795.4	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 4 (Osteosarcoma)	-8588.1	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	-10529.6	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

Complete source fields

classes

categories
measurements
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG002
spread
NA
value
-76081.1
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG003
spread
NA
value
-40512.6
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG005
spread
NA
value
-51199.4
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
units
Participants
title
c-KIT high trough concentration
categories
measurements
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG000
spread
NA
value
-13480.5
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG001
spread
NA
value
-44973.7
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG003
spread
NA
value
-48764.1
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG005
spread
NA
value
-35678.6
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
units
Participants
title
c-KIT low trough concentration
categories
measurements
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG002
spread
NA
value
-7.0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants
title
FGF high trough concentration
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants
title
FGF low trough concentration
categories
measurements
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG002
spread
NA
value
78.3
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG003
spread
NA
value
15.6
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG005
spread
NA
value
45.4
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
units
Participants
title
PGF high trough concentration
categories
measurements
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG001
spread
NA
value
5.6
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG003
spread
NA
value
28.3
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants
title
PGF low trough concentration
categories
measurements
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG002
spread
NA
value
2553.0
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG003
spread
NA
value
-509.4
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG005
spread
NA
value
-2708.2
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
units
Participants
title
TIE2 high trough concentration
categories
measurements
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG000
spread
NA
value
1212.4
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG001
spread
NA
value
-1514.9
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG003
spread
NA
value
-918.4
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG005
spread
NA
value
-473.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
units
Participants
title
TIE2 low trough concentration
categories
measurements
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG002
spread
NA
value
358.8
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG003
spread
NA
value
34.3
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG005
spread
NA
value
-73.3
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
units
Participants
title
VEGF-A high trough concentration
categories
measurements
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG000
spread
NA
value
2436.6
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG001
spread
NA
value
18.5
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG003
spread
NA
value
52.3
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG005
spread
NA
value
39.7
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
units
Participants
title
VEGF-A low trough concentration
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants
title
VEGF-C high trough concentration
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants
title
VEGF-C low trough concentration

denoms

counts
group Id
OG000
value
12
group Id
OG001
value
11
group Id
OG002
value
9
group Id
OG003
value
9
group Id
OG004
value
3
group Id
OG005
value
4
group Id
OG006
value
3
units
Participants

description

Participants with steady state trough concentration median levels for the following biomarker parameters (proto-oncogene c-KIT (c-KIT), Fibroblast growth factor (FGF), Placental growth factor PGF), Angiopoietin-1 receptor (TIE2), Vascular endothelial growth factor A (VEGF-A), Vascular endothelial growth factor C (VEGF-C), Vascular endothelial growth factor D (VEGF-D), Vascular endothelial growth factor receptor 1 (VEGFR-1) and Vascular endothelial growth factor receptor 2 (VEGFR-2)) above the median levels were classified as high or below median levels were classified as low. Only descriptive analysis performed.

dispersion Type

Standard Deviation

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

MEAN

population Description

Biomarker set. Only patient with steady state trough plasma Pazopanib concentration included in the analysis.

reporting Status

POSTED

time Frame

predose Cycle 1 Day 1, Cycle 2 Day 1

title

Summary for Change From Baseline Levels of Plasma Biomarkers by High and Low Pazopanib Steady State Trough Concentration and Cohort

type

SECONDARY

unit Of Measure

picogram/milliliter (pg/mL)

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Preserved source evidence · Not medical advice