A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Recommended Phase 2 Dose (RP2D) of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A)

  Measured over: Cycles 1 and 2 (21 Day Cycles)

• Number or Participants With Dose Limiting Toxicities (DLTs) in Part A

  Measured over: Cycle 1 (21 Day Cycle)

• Maximum Tolerated Dose (MTD) of Abemaciclib in Part A

  Measured over: 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

  Measured over: 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

  Measured over: 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

  Measured over: 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)

  Measured over: Cycles 1 and 2 (21 Day Cycles)

• Number or Participants With DLTs in Part B

  Measured over: Cycle 1 (21 Day Cycle)

• MTD of Abemaciclib in Part B

  Measured over: Cycle 1 (21 Days)

• PK: AUC0-tlast of Abemaciclib in Part B

  Measured over: 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

  Measured over: 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.

  Measured over: Date of first dose to disease progression or death (Up to 25 Months)

Changes Tremor has spotted