Skip to content

TriangleGet started

← Full study record

NCT01956669 · OUTCOME

Summary for Plasma Biomarkers Levels on Cycle 1 Day 1 and Cycle 2 Day 1 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: picogram/milliliter (pg/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: predose Cycle 1 Day 1, Cycle 2 Day 1

What was measured

The following biomarker parameters were analyzed: 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)). Only descriptive analysis performed.

Analysis population: Biomarker 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

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 (C1D1)

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	12
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	10
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	9
Cohort 4 (Osteosarcoma)	8
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	2
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	3
Cohort 7 (Hepatoblastoma)	3

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	139522.4	29.4	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	142526.9	24.3	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	135024.5	25.9	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	137317.7	23.9	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	142630.1	18.0	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	113596.9	26.6	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	119921.9	30.6	Not reported	Not reported	Not reported

c-KIT (C2D1)

Analysis denominator · Participants

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

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	110154.0	14.1	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	99962.7	8.2	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	94307.1	15.1	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	99989.6	18.9	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	121497.7	23.0	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	71216.5	2.0	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	154558.2	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

FGF (C1D1)

Analysis denominator · Participants

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

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	7.8	63.1	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	6.9	71.1	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	8.3	59.1	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	5.9	6.0	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	13.5	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

FGF (C2D1)

Analysis denominator · Participants

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

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	15.1	68.9	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	6.2	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	5.1	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	6.6	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

PGF (C1D1)

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	12
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	9
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	7
Cohort 4 (Osteosarcoma)	8
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	2
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	2
Cohort 7 (Hepatoblastoma)	3

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	19.6	245.7	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	8.9	27.6	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	9.4	36.9	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	10.5	37.0	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	9.3	6.2	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	13.7	126.6	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	8.6	29.7	Not reported	Not reported	Not reported

PGF (C2D1)

Analysis denominator · Participants

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

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	54.6	259.4	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	27.8	74.9	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	37.4	82.9	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	63.2	113.8	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	30.3	300.5	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	225.2	840.1	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	39.4	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

TIE2 (C1D1)

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	12
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	10
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	9
Cohort 4 (Osteosarcoma)	8
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	2
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	3
Cohort 7 (Hepatoblastoma)	3

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	8086.8	26.5	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	8180.0	25.0	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	7280.6	15.6	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	8574.9	7.7	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	7439.8	4.6	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	8179.2	30.0	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	7842.2	18.3	Not reported	Not reported	Not reported

TIE2 (C2D1)

Analysis denominator · Participants

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

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	8340.1	11.5	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	7788.8	11.5	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	7650.6	22.7	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	7894.1	17.4	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	8026.6	28.2	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	6824.4	32.0	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	8540.0	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGF-A (C1D1)

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	12
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	10
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	9
Cohort 4 (Osteosarcoma)	8
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	2
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	3
Cohort 7 (Hepatoblastoma)	3

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	63.8	133.8	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	46.1	66.1	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	74.0	98.0	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	82.9	62.0	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	48.8	39.0	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	62.2	268.3	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	129.3	46.6	Not reported	Not reported	Not reported

VEGF-A (C2D1)

Analysis denominator · Participants

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

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	123.3	140.6	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	77.2	166.8	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	171.8	126.0	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	179.4	98.7	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	219.3	40.4	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	1057.5	750.0	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	208.9	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGF-C (C1D1)

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	2
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	2
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

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	121.4	1.6	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	152.6	84.7	Not reported	Not reported	Not reported

VEGF-C (C2D1)

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)	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: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	105.9	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	339.9	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGF-D (C1D1)

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	12
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	10
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	9
Cohort 4 (Osteosarcoma)	8
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	2
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	3
Cohort 7 (Hepatoblastoma)	3

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	354.2	54.6	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	372.3	20.5	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	394.6	21.6	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	375.4	43.9	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	645.4	108.7	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	351.7	12.1	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	370.0	75.9	Not reported	Not reported	Not reported

VEGF-D (C2D1)

Analysis denominator · Participants

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

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	434.6	77.4	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	501.8	43.0	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	448.6	16.9	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	551.7	14.4	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	501.4	50.1	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	791.4	51.1	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	400.4	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGFR-1 (C1D1)

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	12
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	10
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	9
Cohort 4 (Osteosarcoma)	8
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	2
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	3
Cohort 7 (Hepatoblastoma)	3

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	394.5	292.3	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	175.7	174.4	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	224.4	121.7	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	134.6	113.7	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	95.8	42.9	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	367.5	130.8	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	173.4	109.6	Not reported	Not reported	Not reported

VEGFR-1 (C2D1)

Analysis denominator · Participants

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

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	87.5	98.5	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	534.3	709.9	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	93.8	121.1	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	140.0	231.3	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	69.4	4.9	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	76.4	14.6	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	1811.6	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

VEGFR-2 (C1D1)

Analysis denominator · Participants

Group	Source count
Cohort 1: Rhabdomyosarcoma (RMS)	12
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	10
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	9
Cohort 4 (Osteosarcoma)	8
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	2
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	3
Cohort 7 (Hepatoblastoma)	3

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	31451.9	22.6	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	31745.8	20.6	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	33724.8	15.8	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	34993.1	17.6	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	31682.1	12.1	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	39342.8	14.7	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	30780.5	6.0	Not reported	Not reported	Not reported

VEGFR-2 (C2D1)

Analysis denominator · Participants

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

Values in picogram/milliliter (pg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Rhabdomyosarcoma (RMS)	25099.6	22.9	Not reported	Not reported	Not reported
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)	23059.9	21.6	Not reported	Not reported	Not reported
Cohort 3: Ewing Sarcoma/pPNET (Ewing)	23502.8	1.0	Not reported	Not reported	Not reported
Cohort 4 (Osteosarcoma)	22154.3	15.1	Not reported	Not reported	Not reported
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)	25385.9	42.9	Not reported	Not reported	Not reported
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)	13621.6	68.5	Not reported	Not reported	Not reported
Cohort 7 (Hepatoblastoma)	26266.9	NA	Not reported	Not reported	NA: Not estimable due to insufficient number of participants with events

Complete source fields

classes

categories
measurements
group Id
OG000
spread
29.4
value
139522.4
group Id
OG001
spread
24.3
value
142526.9
group Id
OG002
spread
25.9
value
135024.5
group Id
OG003
spread
23.9
value
137317.7
group Id
OG004
spread
18.0
value
142630.1
group Id
OG005
spread
26.6
value
113596.9
group Id
OG006
spread
30.6
value
119921.9
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
10
group Id
OG002
value
9
group Id
OG003
value
8
group Id
OG004
value
2
group Id
OG005
value
3
group Id
OG006
value
3
units
Participants
title
c-KIT (C1D1)
categories
measurements
group Id
OG000
spread
14.1
value
110154.0
group Id
OG001
spread
8.2
value
99962.7
group Id
OG002
spread
15.1
value
94307.1
group Id
OG003
spread
18.9
value
99989.6
group Id
OG004
spread
23.0
value
121497.7
group Id
OG005
spread
2.0
value
71216.5
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG006
spread
NA
value
154558.2
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
4
group Id
OG004
value
2
group Id
OG005
value
2
group Id
OG006
value
1
units
Participants
title
c-KIT (C2D1)
categories
measurements
group Id
OG000
spread
63.1
value
7.8
group Id
OG001
spread
71.1
value
6.9
group Id
OG002
spread
59.1
value
8.3
group Id
OG003
spread
6.0
value
5.9
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG005
spread
NA
value
13.5
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
units
Participants
title
FGF (C1D1)
categories
measurements
group Id
OG000
spread
68.9
value
15.1
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG001
spread
NA
value
6.2
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG002
spread
NA
value
5.1
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG004
spread
NA
value
6.6
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
0
units
Participants
title
FGF (C2D1)
categories
measurements
group Id
OG000
spread
245.7
value
19.6
group Id
OG001
spread
27.6
value
8.9
group Id
OG002
spread
36.9
value
9.4
group Id
OG003
spread
37.0
value
10.5
group Id
OG004
spread
6.2
value
9.3
group Id
OG005
spread
126.6
value
13.7
group Id
OG006
spread
29.7
value
8.6
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
9
group Id
OG002
value
7
group Id
OG003
value
8
group Id
OG004
value
2
group Id
OG005
value
2
group Id
OG006
value
3
units
Participants
title
PGF (C1D1)
categories
measurements
group Id
OG000
spread
259.4
value
54.6
group Id
OG001
spread
74.9
value
27.8
group Id
OG002
spread
82.9
value
37.4
group Id
OG003
spread
113.8
value
63.2
group Id
OG004
spread
300.5
value
30.3
group Id
OG005
spread
840.1
value
225.2
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG006
spread
NA
value
39.4
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
4
group Id
OG004
value
2
group Id
OG005
value
2
group Id
OG006
value
1
units
Participants
title
PGF (C2D1)
categories
measurements
group Id
OG000
spread
26.5
value
8086.8
group Id
OG001
spread
25.0
value
8180.0
group Id
OG002
spread
15.6
value
7280.6
group Id
OG003
spread
7.7
value
8574.9
group Id
OG004
spread
4.6
value
7439.8
group Id
OG005
spread
30.0
value
8179.2
group Id
OG006
spread
18.3
value
7842.2
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
10
group Id
OG002
value
9
group Id
OG003
value
8
group Id
OG004
value
2
group Id
OG005
value
3
group Id
OG006
value
3
units
Participants
title
TIE2 (C1D1)
categories
measurements
group Id
OG000
spread
11.5
value
8340.1
group Id
OG001
spread
11.5
value
7788.8
group Id
OG002
spread
22.7
value
7650.6
group Id
OG003
spread
17.4
value
7894.1
group Id
OG004
spread
28.2
value
8026.6
group Id
OG005
spread
32.0
value
6824.4
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG006
spread
NA
value
8540.0
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
4
group Id
OG004
value
2
group Id
OG005
value
2
group Id
OG006
value
1
units
Participants
title
TIE2 (C2D1)
categories
measurements
group Id
OG000
spread
133.8
value
63.8
group Id
OG001
spread
66.1
value
46.1
group Id
OG002
spread
98.0
value
74.0
group Id
OG003
spread
62.0
value
82.9
group Id
OG004
spread
39.0
value
48.8
group Id
OG005
spread
268.3
value
62.2
group Id
OG006
spread
46.6
value
129.3
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
10
group Id
OG002
value
9
group Id
OG003
value
8
group Id
OG004
value
2
group Id
OG005
value
3
group Id
OG006
value
3
units
Participants
title
VEGF-A (C1D1)
categories
measurements
group Id
OG000
spread
140.6
value
123.3
group Id
OG001
spread
166.8
value
77.2
group Id
OG002
spread
126.0
value
171.8
group Id
OG003
spread
98.7
value
179.4
group Id
OG004
spread
40.4
value
219.3
group Id
OG005
spread
750.0
value
1057.5
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG006
spread
NA
value
208.9
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
4
group Id
OG004
value
2
group Id
OG005
value
2
group Id
OG006
value
1
units
Participants
title
VEGF-A (C2D1)
categories
measurements
group Id
OG000
spread
1.6
value
121.4
group Id
OG001
spread
84.7
value
152.6
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
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 (C1D1)
categories
measurements
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG000
spread
NA
value
105.9
comment
NA: Not estimable due to insufficient number of participants with events
group Id
OG001
spread
NA
value
339.9
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
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 (C2D1)

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

The following biomarker parameters were analyzed: 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)). Only descriptive analysis performed.

dispersion Type

Geometric Coefficient of Variation

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

GEOMETRIC_MEAN

population Description

Biomarker set

reporting Status

POSTED

time Frame

predose Cycle 1 Day 1, Cycle 2 Day 1

title

Summary for Plasma Biomarkers Levels on Cycle 1 Day 1 and Cycle 2 Day 1 by Cohort

type

SECONDARY

unit Of Measure

picogram/milliliter (pg/mL)

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

Preserved source evidence · Not medical advice