{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"}],"units":"Participants"}],"description":"Based on the 3+3 design, the MTD of APX005M was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a DLT, and the next higher dose level was determined to be too toxic. A total of 12 subjects were to be treated at the MTD/RP2D to further define the toxicity profile. Stratum 1 consisted of patients with recurrent or refractory primary malignant central nervous system tumors.","groups":[{"description":"Recurrent, progressive, or refractory primary malignant non-brainstem CNS tumor patients treated with APX005M.\n\nThe dose levels studied were 0.1 mg/kg (dose level 1), 0.3 mg/kg (dose level 2), and 0.6 mg/kg (dose level 3).\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 1"}],"paramType":"NUMBER","populationDescription":"Patients who were enrolled on Stratum 1 and evaluable for dose-finding assessment were used to determine the MTD for Stratum 1. Of 20 eligible patients enrolled on Stratum 1, 2 were not evaluable for dose-finding assessment due to early progressive disease (these 2 participants received less than 2 doses of treatment). The remaining 18 patients were used to determine the MTD/RP2D for Stratum 1.","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 1","type":"PRIMARY","unitOfMeasure":"mg/kg"}