Participant flow

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma · Source last updated 2026-03-02

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

groups

1. description

   Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

   id

   FG000

   title

   Part A Cohort A1

2. description

   Participants received: * Abemaciclib: 55 mg/m², administered orally BID. * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

   id

   FG001

   title

   Part A Cohort A-1

3. description

   Participants received: * Abemaciclib: 70 mg/m², administered orally BID. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

   id

   FG002

   title

   Part B Cohort B1

4. description

   Participants received: * Abemaciclib: 90 mg/m², administered orally BID. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

   id

   FG003

   title

   Part B Cohort B2

5. description

   Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

   id

   FG004

   title

   Part B Cohort B3

6. description

   Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

   id

   FG005

   title

   Part B Cohort B5

7. description

   Participants received: * Abemaciclib: 55 mg/m², administered orally BID. * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. * Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle. * Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

   id

   FG006

   title

   Part C Cohort C1

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         0

      type

      Discontinued study treatment, but follow-up visit was not completed due to primary study condition

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      type

      Withdrawal by Parent/Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         9

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         11

      7. group Id

         FG006

         num Subjects

         1

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         9

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         11

      7. group Id

         FG006

         num Subjects

         1

      type

      Received At Least One Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         7

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         10

      7. group Id

         FG006

         num Subjects

         0

      comment

      A participant was identified as having completed the study if the participant died while on the study or the participant discontinued study treatment and completed the follow-up period at the time of the final analysis.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice