The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment. For each participant, the study is estimated to last up to 2 years.
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Recommended Phase 2 Dose (RP2D) of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A)
Timeframe: Cycles 1 and 2 (21 Day Cycles)
Number or Participants With Dose Limiting Toxicities (DLTs) in Part A
Timeframe: Cycle 1 (21 Day Cycle)
Maximum Tolerated Dose (MTD) of Abemaciclib in Part A
Timeframe: Cycle 1 (21 Days)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC0-tlast) of Abemaciclib in Part A
Timeframe: Pre-dose, 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
PK: (AUC0-tlast) of Irinotecan in Part A
Timeframe: 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
PK: (AUC0-tlast) of Temozolomide in Part A
Timeframe: 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
RP2D of Abemaciclib in Combination With Temozolomide (Part B)
Timeframe: Cycles 1 and 2 (21 Day Cycles)
Number or Participants With DLTs in Part B
Timeframe: Cycle 1 (21 Day Cycle)
MTD of Abemaciclib in Part B
Timeframe: Cycle 1 (21 Days)
PK: AUC0-tlast of Abemaciclib in Part B
Timeframe: Pre-dose, 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
PK: AUC0-tlast of Temozolomide in Part B
Timeframe: 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
Number of Participants With Overall Response Rate (ORR) in Part C.
Timeframe: Date of first dose to disease progression or death (Up to 25 Months)