{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.1","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Brain tumor results (Day 0)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.00","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Day 0 time of resection - veledimex plasma PK"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Day 1 predose- veledimex plasma PK"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.61","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Day 1 2 hr postdose- veledimex plasma PK"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.31","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Day 1 4 hr postdose- veledimex plasma PK"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.91","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Day 1 6 hr postdose- veledimex plasma PK"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.4","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Day 2 - veledimex plasma PK"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.61","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Day 14 predose- veledimex plasma PK"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.3","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Day 14 2 hr postdose - veledimex plasma PK"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.19","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Day 14 4 hr postdose - veledimex plasma PK"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.41","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Day 14 6 hr postdose - veledimex plasma PK"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.13","upperLimit":"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.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Day 15 24 hr postdose - veledimex plasma PK"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"description":"Veledimex brain concentration. Veledimex plasma concentration was below the limit of quantitation for most patients.\n\nGiven 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.","dispersionType":"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.\n\nAd-RTS-hIL-12: 2.0 x 10\\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12\n\nOral Veledimex - Arm 1 (Pediatric Brain Tumor):\n\n* Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex\n* 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.\n\nAd-RTS-hIL-12: 2.0 x 10\\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12\n\nOral Veledimex - Arm 2 (DIPG):\n\n* Planned:2 dose levels (10mg/day, 20mg/day)\n* Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.","id":"OG001","title":"Arm 2 - Closed"}],"paramType":"MEAN","populationDescription":"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.\n\nArm 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.","reportingStatus":"POSTED","timeFrame":"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","unitOfMeasure":"ng/mL"}