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NCT04238819 · OUTCOME

PK: AUC0-tlast of Abemaciclib in Part B

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.

Measure
GEOMETRIC_MEAN
Unit
ng*h/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose, 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)

What was measured

PK: AUC0-tlast was reported.

Analysis population: All participants in Part B who received at least one dose of abemaciclib and had evaluable PK data. Per planned analysis, PK analysis was performed as per the dose of study drug received.

Groups in this outcome

Part B: 70 mg/m² Abemaciclib

All part B participants who received 70 mg/m² abemaciclib were included under this arm.

Part B: 90 mg/m² Abemaciclib

All part B participants who received 90 mg/m² abemaciclib were included under this arm.

Part B: 115 mg/m² Abemaciclib

All part B participants who received 115 mg/m² abemaciclib were included under this arm.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part B: 70 mg/m² Abemaciclib3
Part B: 90 mg/m² Abemaciclib8
Part B: 115 mg/m² Abemaciclib14

Reported measurements

Cycle 1, Day 1

Analysis denominator · Participants

GroupSource count
Part B: 70 mg/m² Abemaciclib3
Part B: 90 mg/m² Abemaciclib8
Part B: 115 mg/m² Abemaciclib14
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: 70 mg/m² Abemaciclib566104Not reportedNot reportedNot reported
Part B: 90 mg/m² Abemaciclib72860Not reportedNot reportedNot reported
Part B: 115 mg/m² Abemaciclib72877Not reportedNot reportedNot reported
Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Part B: 70 mg/m² Abemaciclib2
Part B: 90 mg/m² Abemaciclib5
Part B: 115 mg/m² Abemaciclib10
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: 70 mg/m² AbemaciclibNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported: 994.32 ng\*h/mL and 2247.03 ng\*h/mL.
Part B: 90 mg/m² Abemaciclib60027Not reportedNot reportedNot reported
Part B: 115 mg/m² Abemaciclib106057Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        104
        value
        566
      2. group Id
        OG001
        spread
        60
        value
        728
      3. group Id
        OG002
        spread
        77
        value
        728
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        14
      units
      Participants
    title
    Cycle 1, Day 1
  2. categories
    1. measurements
      1. comment
        Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported: 994.32 ng\*h/mL and 2247.03 ng\*h/mL.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. group Id
        OG001
        spread
        27
        value
        600
      3. group Id
        OG002
        spread
        57
        value
        1060
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        10
      units
      Participants
    title
    Cycle 2, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      14
    units
    Participants
description
PK: AUC0-tlast was reported.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    All part B participants who received 70 mg/m² abemaciclib were included under this arm.
    id
    OG000
    title
    Part B: 70 mg/m² Abemaciclib
  2. description
    All part B participants who received 90 mg/m² abemaciclib were included under this arm.
    id
    OG001
    title
    Part B: 90 mg/m² Abemaciclib
  3. description
    All part B participants who received 115 mg/m² abemaciclib were included under this arm.
    id
    OG002
    title
    Part B: 115 mg/m² Abemaciclib
param Type
GEOMETRIC_MEAN
population Description
All participants in Part B who received at least one dose of abemaciclib and had evaluable PK data. Per planned analysis, PK analysis was performed as per the dose of study drug received.
reporting Status
POSTED
time Frame
Pre-dose, 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
title
PK: AUC0-tlast of Abemaciclib in Part B
type
PRIMARY
unit Of Measure
ng*h/mL

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Preserved source evidence · Not medical advice