NCT03389802 · OUTCOME
Concentration of the Cytokine Tumor Necrosis Factor-alpha (TNF-alpha)
Phase I Study of APX005M in Pediatric Central Nervous System Tumors · Source last updated 2026-08-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- pg/ml
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-treatment (week 0), 1 week, 2 week, 3 weeks, 6 weeks and 9 weeks post-treatment
What was measured
The cytokine was quantitated using V-PLEX Human Proinflammatory Panel, a multiplex immunoassay kit developed by Meso Scale Diagnostics (MSD). A four-parameter logistic fit calibration curve was generated and used to calculate concentrations in tested samples. Analyses were performed at pre-treatment and 1 week following the first dose of drug and additionally at 2, 3, 6, and 9 weeks following the course 1 drug dose if feasible. The mean concentration of TNF-alpha in pg/ml was reported with a standard deviation. When only one patient was analyzed, the standard deviation was reported as 0 (rather than undefined).
Analysis population: Not all patients had data available at every time point.
Groups in this outcome
Stratum 1, Dose Level 1
Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Stratum 1, Dose Level 2
Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Stratum 1, Dose Level 3
Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Stratum 2, Dose Level 2
Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Stratum 2, Dose Level 3
Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
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 |
|---|
| Stratum 1, Dose Level 1 | 2 |
|---|
| Stratum 1, Dose Level 2 | 3 |
|---|
| Stratum 1, Dose Level 3 | 12 |
|---|
| Stratum 2, Dose Level 2 | 6 |
|---|
| Stratum 2, Dose Level 3 | 2 |
|---|
Reported measurements
Week 0
Analysis denominator · Participants
| Group | Source count |
|---|
| Stratum 1, Dose Level 1 | 1 |
|---|
| Stratum 1, Dose Level 2 | 1 |
|---|
| Stratum 1, Dose Level 3 | 10 |
|---|
| Stratum 2, Dose Level 2 | 5 |
|---|
| Stratum 2, Dose Level 3 | 2 |
|---|
Values in pg/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stratum 1, Dose Level 1 | 0.95 | 0 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 2 | 1.24 | 0 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 3 | 0.71 | 0.28 | Not reported | Not reported | Not reported |
|---|
| Stratum 2, Dose Level 2 | 0.87 | 0.48 | Not reported | Not reported | Not reported |
|---|
| Stratum 2, Dose Level 3 | 0.41 | 0.18 | Not reported | Not reported | Not reported |
|---|
Week 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Stratum 1, Dose Level 1 | 2 |
|---|
| Stratum 1, Dose Level 2 | 2 |
|---|
| Stratum 1, Dose Level 3 | 11 |
|---|
| Stratum 2, Dose Level 2 | 6 |
|---|
| Stratum 2, Dose Level 3 | 2 |
|---|
Values in pg/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stratum 1, Dose Level 1 | 1.02 | 0.22 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 2 | 1.31 | 0.49 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 3 | 0.75 | 0.19 | Not reported | Not reported | Not reported |
|---|
| Stratum 2, Dose Level 2 | 0.92 | 0.65 | Not reported | Not reported | Not reported |
|---|
| Stratum 2, Dose Level 3 | 0.44 | 0.10 | Not reported | Not reported | Not reported |
|---|
Week 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Stratum 1, Dose Level 1 | 2 |
|---|
| Stratum 1, Dose Level 2 | 3 |
|---|
| Stratum 1, Dose Level 3 | 9 |
|---|
| Stratum 2, Dose Level 2 | 6 |
|---|
| Stratum 2, Dose Level 3 | 1 |
|---|
Values in pg/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stratum 1, Dose Level 1 | 0.92 | 0.35 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 2 | 1.43 | 0.01 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 3 | 0.97 | 0.38 | Not reported | Not reported | Not reported |
|---|
| Stratum 2, Dose Level 2 | 0.79 | 0.33 | Not reported | Not reported | Not reported |
|---|
| Stratum 2, Dose Level 3 | 1.03 | 0 | Not reported | Not reported | Not reported |
|---|
Week 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Stratum 1, Dose Level 1 | 1 |
|---|
| Stratum 1, Dose Level 2 | 3 |
|---|
| Stratum 1, Dose Level 3 | 10 |
|---|
| Stratum 2, Dose Level 2 | 4 |
|---|
| Stratum 2, Dose Level 3 | 2 |
|---|
Values in pg/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stratum 1, Dose Level 1 | 1.15 | 0 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 2 | 1.42 | 0.34 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 3 | 0.83 | 0.35 | Not reported | Not reported | Not reported |
|---|
| Stratum 2, Dose Level 2 | 1.12 | 0.74 | Not reported | Not reported | Not reported |
|---|
| Stratum 2, Dose Level 3 | 26.07 | 35.73 | Not reported | Not reported | Not reported |
|---|
Week 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Stratum 1, Dose Level 1 | 1 |
|---|
| Stratum 1, Dose Level 2 | 3 |
|---|
| Stratum 1, Dose Level 3 | 8 |
|---|
| Stratum 2, Dose Level 2 | 4 |
|---|
| Stratum 2, Dose Level 3 | 0 |
|---|
Values in pg/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stratum 1, Dose Level 1 | 1.07 | 0 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 2 | 1.37 | 0.54 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 3 | 0.79 | 0.34 | Not reported | Not reported | Not reported |
|---|
| Stratum 2, Dose Level 2 | 0.84 | 0.40 | Not reported | Not reported | Not reported |
|---|
Week 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Stratum 1, Dose Level 1 | 1 |
|---|
| Stratum 1, Dose Level 2 | 2 |
|---|
| Stratum 1, Dose Level 3 | 3 |
|---|
| Stratum 2, Dose Level 2 | 2 |
|---|
| Stratum 2, Dose Level 3 | 1 |
|---|
Values in pg/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stratum 1, Dose Level 1 | 1.57 | 0 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 2 | 1.81 | 0.83 | Not reported | Not reported | Not reported |
|---|
| Stratum 1, Dose Level 3 | 0.83 | 0.35 | Not reported | Not reported | Not reported |
|---|
| Stratum 2, Dose Level 2 | 1.26 | 0.60 | Not reported | Not reported | Not reported |
|---|
| Stratum 2, Dose Level 3 | 0.35 | 0 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 0.95
- group Id
- OG001
- spread
- 0
- value
- 1.24
- group Id
- OG002
- spread
- 0.28
- value
- 0.71
- group Id
- OG003
- spread
- 0.48
- value
- 0.87
- group Id
- OG004
- spread
- 0.18
- value
- 0.41
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 2
- units
- Participants
- title
- Week 0
- categories
- measurements
- group Id
- OG000
- spread
- 0.22
- value
- 1.02
- group Id
- OG001
- spread
- 0.49
- value
- 1.31
- group Id
- OG002
- spread
- 0.19
- value
- 0.75
- group Id
- OG003
- spread
- 0.65
- value
- 0.92
- group Id
- OG004
- spread
- 0.10
- value
- 0.44
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 2
- units
- Participants
- title
- Week 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.35
- value
- 0.92
- group Id
- OG001
- spread
- 0.01
- value
- 1.43
- group Id
- OG002
- spread
- 0.38
- value
- 0.97
- group Id
- OG003
- spread
- 0.33
- value
- 0.79
- group Id
- OG004
- spread
- 0
- value
- 1.03
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 1
- units
- Participants
- title
- Week 2
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 1.15
- group Id
- OG001
- spread
- 0.34
- value
- 1.42
- group Id
- OG002
- spread
- 0.35
- value
- 0.83
- group Id
- OG003
- spread
- 0.74
- value
- 1.12
- group Id
- OG004
- spread
- 35.73
- value
- 26.07
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- units
- Participants
- title
- Week 3
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 1.07
- group Id
- OG001
- spread
- 0.54
- value
- 1.37
- group Id
- OG002
- spread
- 0.34
- value
- 0.79
- group Id
- OG003
- spread
- 0.40
- value
- 0.84
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- Week 6
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 1.57
- group Id
- OG001
- spread
- 0.83
- value
- 1.81
- group Id
- OG002
- spread
- 0.35
- value
- 0.83
- group Id
- OG003
- spread
- 0.60
- value
- 1.26
- group Id
- OG004
- spread
- 0
- value
- 0.35
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- units
- Participants
- title
- Week 9
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 2
- units
- Participants
- description
- The cytokine was quantitated using V-PLEX Human Proinflammatory Panel, a multiplex immunoassay kit developed by Meso Scale Diagnostics (MSD). A four-parameter logistic fit calibration curve was generated and used to calculate concentrations in tested samples. Analyses were performed at pre-treatment and 1 week following the first dose of drug and additionally at 2, 3, 6, and 9 weeks following the course 1 drug dose if feasible. The mean concentration of TNF-alpha in pg/ml was reported with a standard deviation. When only one patient was analyzed, the standard deviation was reported as 0 (rather than undefined).
- dispersion Type
- Standard Deviation
- groups
- description
- Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG000
- title
- Stratum 1, Dose Level 1
- description
- Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG001
- title
- Stratum 1, Dose Level 2
- description
- Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG002
- title
- Stratum 1, Dose Level 3
- description
- Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG003
- title
- Stratum 2, Dose Level 2
- description
- Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG004
- title
- Stratum 2, Dose Level 3
- param Type
- MEAN
- population Description
- Not all patients had data available at every time point.
- reporting Status
- POSTED
- time Frame
- Pre-treatment (week 0), 1 week, 2 week, 3 weeks, 6 weeks and 9 weeks post-treatment
- title
- Concentration of the Cytokine Tumor Necrosis Factor-alpha (TNF-alpha)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- pg/ml
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Preserved source evidence · Not medical advice
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