{"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":"FG000","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":"FG001","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":"FG002","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":"FG003","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":"FG004","title":"Stratum 2, Dose Level 3"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"13"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"1"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"4"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Subject deemed ineligible after enrollment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"5"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"5"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Patients with recurrent or refractory primary malignant CNS tumors were enrolled on stratum 1, and patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) were enrolled on stratum 2. A total of 32 patients were enrolled (31 eligible). Twenty-one (21) stratum 1 patients were enrolled; 1 of these patients was deemed to be ineligible as an eligibility assessment was not performed. Eleven (11) stratum 2 patients were enrolled (all deemed eligible).","recruitmentDetails":"Patients ≥1 and ≤21 years of age with recurrent or refractory primary malignant central nervous system (CNS) tumors (Stratum 1) or newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum 2) were enrolled at Pediatric Brain Tumor Consortium (PBTC) member institutions. The first patient was enrolled on 3/1/2018 and the last patient was enrolled on 1/20/2023. Accrual was closed after the maximum tolerated dose/recommended phase II dose was determined for both strata."}