NCT04238819 · OUTCOME

PK: (AUC0-tlast) of Irinotecan in Part A

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: 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 Part A participants who received at least one dose of irinotecan and had evaluable PK data. Per planned analysis, PK analysis was performed as per the dose of drug received.

Groups in this outcome

Part A: 50 mg/m²/Day Irinotecan

All part A participants who received 50 mg/m²/day irinotecan 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

Group	Source count
Part A: 50 mg/m²/Day Irinotecan	20

Reported measurements

Cycle 1, Day 1

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part A: 50 mg/m²/Day Irinotecan	1450	37	Not reported	Not reported	Not reported

Cycle 2, Day 1

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part A: 50 mg/m²/Day Irinotecan	1240	58	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
37
value
1450
title
Cycle 1, Day 1
categories
measurements
group Id
OG000
spread
58
value
1240
title
Cycle 2, Day 1

denoms

counts
group Id
OG000
value
20
units
Participants

description

PK: AUC0-tlast) was reported.

dispersion Type

Geometric Coefficient of Variation

groups

description
All part A participants who received 50 mg/m²/day irinotecan were included under this arm.
id
OG000
title
Part A: 50 mg/m²/Day Irinotecan

param Type

GEOMETRIC_MEAN

population Description

All Part A participants who received at least one dose of irinotecan and had evaluable PK data. Per planned analysis, PK analysis was performed as per the dose of drug received.

reporting Status

POSTED

time Frame

2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)

title

PK: (AUC0-tlast) of Irinotecan in Part A

type

PRIMARY

unit Of Measure

ng*h/mL

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Preserved source evidence · Not medical advice