{"groups":[{"description":"Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day","id":"FG000","title":"Phase I, Dose Level 1"},{"description":"Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day","id":"FG001","title":"Phase I, Dose Level 2"},{"description":"Patients who are undergoing surgery also received ribociclib PO QD on days 7-10 at 120 mg/m2/day before surgery. Eligible patients were subsequently treated on Phase 1, Dose Level 1.","id":"FG002","title":"Surgical"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"5"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"5"}],"type":"Received Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"5"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Total 22 eligible patients were enrolled. 16 of them enrolled on the Phase I study and 6 on the surgical cohort. The 'Started' row includes patients who are eligible for the study. One patient in Phase I dose level 1 withdrew prior to protocol therapy and one patient in Surgical study was not eligible for subsequent protocol therapy. The 'Completed' row includes patients who completed all Phase I protocol therapy or who experienced a protocol defined endpoint which took them off therapy.","recruitmentDetails":"This is Phase I and Surgical study for children with retinoblastoma protein 1 (Rb1) positive recurrent or refractory central nervous system tumors. Patients were enrolled at Pediatric Brain Tumor Consortium member institutions. The first patient was enrolled on 03/13/2018 and the last patient was enrolled on 11/18/2019. Patients who were enrolled under Surgical study may also be eligible to receive subsequent Phase I defined treatment and evaluable for DLT."}