{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"}],"description":"The starting dose level for Stratum 2 was one dose level below the RP2D determined in Stratum 1. If there were no dose-limiting toxicities in the first 3 patients enrolled on Stratum 2, then we escalated to the Stratum 1 RP2D and could treat 6 diffuse intrinsic pontine glioma (DIPG) patients simultaneously. The RP2D was defined as the dose level at which 6 patients were treated with no more than one dose-limiting toxicity. Stratum 2 patients were those with newly diagnosed diffuse intrinsic pontine glioma (DIPG).","groups":[{"description":"Newly diagnosed diffuse intrinsic pontine gliomas (DIPGs) patients treated with APX005M.\n\nThe dose levels studied were 0.3 mg/kg (dose level 2) and 0.6 mg/kg (dose level 3). Dose level 2 was selected as the starting dose level for Stratum 2 as it was one dose level lower than the Stratum 1 MTD/RP2D.\n\nAPX005M was administered at the assigned dose level every 21 days (3 weeks). Patients could receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death.","id":"OG000","title":"Stratum 2"}],"paramType":"NUMBER","populationDescription":"Patients who were enrolled on Stratum 2 and were evaluable for dose-finding assessment were used to determine the MTD for Stratum 2. Of 11 patients enrolled on Stratum 2, all were evaluable for dose-finding assessment and used to determine the MTD for Stratum 2.","reportingStatus":"POSTED","timeFrame":"6 weeks (first 2 courses of treatment)","title":"Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of APX005M in Stratum 2","type":"PRIMARY","unitOfMeasure":"mg/kg"}