Participant flow

Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors · Source last updated 2021-08-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

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 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

2. 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

3. 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

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         5

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         5

      type

      Received Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         5

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

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.

recruitment Details

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.

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Preserved source evidence · Not medical advice