NCT03330197 · OUTCOME
To Measure the Veledimex in Blood and Brain Tumor by Using the LC-MS Method
A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG · Source last updated 2025-08-12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Full Range
- Time frame
- From Day 0 through Day 15 of veledimex dosing
What was measured
Veledimex brain concentration. Veledimex plasma concentration was below the limit of quantitation for most patients.
Given the limited number of subjects enrolled and early closure of the study, complete assessment of veledimex in blood and brain tumor could not be determined.
Analysis population: Patients with available brain tumor results. Arm 2 patient result was below the level of quantitation (1.8 ng/mL). Arm 1 BLQ was 0.1 ng/mL. One patients was less than BLQ.
Arm 2 patient plasma concentrations were not reported due to bioanalytical non-reproducibility. NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
Groups in this outcome
Arm 1 - Closed
Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors.
Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12
Oral Veledimex - Arm 1 (Pediatric Brain Tumor):
* Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex
* Actual: All patients received 1 dose level (10 mg/day veledimex)
Arm 2 - Closed
Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG.
Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12
Oral Veledimex - Arm 2 (DIPG):
* Planned:2 dose levels (10mg/day, 20mg/day)
* Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.
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 |
|---|
| Arm 1 - Closed | 3 |
|---|
| Arm 2 - Closed | 1 |
|---|
Reported measurements
Brain tumor results (Day 0)
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 0.172 | Not reported | 0.1 | 0.211 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient analyzed in Arm 2, the brain tumor concentration at Day 0 was Below the Quantitation Limit (BQL) of 1.80 ng/mL. All subsequent plasma concentrations for this patient were reported by the laboratory as Non-Reportable Results (NRR) and are therefore not available. |
|---|
Day 0 time of resection - veledimex plasma PK
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 1.40 | Not reported | 1.00 | 1.86 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration. |
|---|
Day 1 predose- veledimex plasma PK
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 1.02 | Not reported | 1 | 1.07 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration. |
|---|
Day 1 2 hr postdose- veledimex plasma PK
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 11.64 | Not reported | 8.61 | 13.8 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration. |
|---|
Day 1 4 hr postdose- veledimex plasma PK
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 5.66 | Not reported | 3.31 | 9.85 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration. |
|---|
Day 1 6 hr postdose- veledimex plasma PK
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 5.64 | Not reported | 2.91 | 11.1 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration. |
|---|
Day 2 - veledimex plasma PK
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 2.09 | Not reported | 1.4 | 2.92 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration. |
|---|
Day 14 predose- veledimex plasma PK
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 4.39 | Not reported | 2.61 | 6.15 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration. |
|---|
Day 14 2 hr postdose - veledimex plasma PK
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 36.83 | Not reported | 14.3 | 66.9 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration. |
|---|
Day 14 4 hr postdose - veledimex plasma PK
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 19.80 | Not reported | 9.19 | 30.9 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration. |
|---|
Day 14 6 hr postdose - veledimex plasma PK
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 7.63 | Not reported | 7.41 | 8.05 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration. |
|---|
Day 15 24 hr postdose - veledimex plasma PK
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 1 - Closed | 4.35 | Not reported | 3.13 | 5.03 | Not reported |
|---|
| Arm 2 - Closed | NA | Not reported | NA | NA | For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.1
- upper Limit
- 0.211
- value
- 0.172
- comment
- For the one patient analyzed in Arm 2, the brain tumor concentration at Day 0 was Below the Quantitation Limit (BQL) of 1.80 ng/mL. All subsequent plasma concentrations for this patient were reported by the laboratory as Non-Reportable Results (NRR) and are therefore not available.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Brain tumor results (Day 0)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 1.86
- value
- 1.40
- comment
- For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 0 time of resection - veledimex plasma PK
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 1.07
- value
- 1.02
- comment
- For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 1 predose- veledimex plasma PK
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.61
- upper Limit
- 13.8
- value
- 11.64
- comment
- For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 1 2 hr postdose- veledimex plasma PK
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.31
- upper Limit
- 9.85
- value
- 5.66
- comment
- For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 1 4 hr postdose- veledimex plasma PK
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.91
- upper Limit
- 11.1
- value
- 5.64
- comment
- For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 1 6 hr postdose- veledimex plasma PK
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 2.92
- value
- 2.09
- comment
- For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 2 - veledimex plasma PK
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.61
- upper Limit
- 6.15
- value
- 4.39
- comment
- For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 14 predose- veledimex plasma PK
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.3
- upper Limit
- 66.9
- value
- 36.83
- comment
- For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 14 2 hr postdose - veledimex plasma PK
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.19
- upper Limit
- 30.9
- value
- 19.80
- comment
- For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 14 4 hr postdose - veledimex plasma PK
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.41
- upper Limit
- 8.05
- value
- 7.63
- comment
- For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 14 6 hr postdose - veledimex plasma PK
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.13
- upper Limit
- 5.03
- value
- 4.35
- comment
- For the one patient who received veledimex and was analyzed, plasma concentration was reported by the lab as NRR (Non-Reportable Results). NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Day 15 24 hr postdose - veledimex plasma PK
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- Veledimex brain concentration. Veledimex plasma concentration was below the limit of quantitation for most patients.
Given the limited number of subjects enrolled and early closure of the study, complete assessment of veledimex in blood and brain tumor could not be determined.
- dispersion Type
- Full Range
- groups
- description
- Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors.
Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12
Oral Veledimex - Arm 1 (Pediatric Brain Tumor):
* Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex
* Actual: All patients received 1 dose level (10 mg/day veledimex)
- id
- OG000
- title
- Arm 1 - Closed
- description
- Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG.
Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12
Oral Veledimex - Arm 2 (DIPG):
* Planned:2 dose levels (10mg/day, 20mg/day)
* Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.
- id
- OG001
- title
- Arm 2 - Closed
- param Type
- MEAN
- population Description
- Patients with available brain tumor results. Arm 2 patient result was below the level of quantitation (1.8 ng/mL). Arm 1 BLQ was 0.1 ng/mL. One patients was less than BLQ.
Arm 2 patient plasma concentrations were not reported due to bioanalytical non-reproducibility. NRR (Non-Reportable Results) is the actual result reported from the central lab which was due to assay reagent expiration.
- reporting Status
- POSTED
- time Frame
- From Day 0 through Day 15 of veledimex dosing
- title
- To Measure the Veledimex in Blood and Brain Tumor by Using the LC-MS Method
- type
- SECONDARY
- unit Of Measure
- ng/mL
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