NCT04238819 · OUTCOME

PK: (AUC0-tlast) of Temozolomide 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_LEAST_SQUARES_MEAN
Unit: ng*h/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: 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 Part A participants who received at least one dose of temozolomide 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: 100 mg/m²/Day Temozolomide

All part A participants who received 100 mg/m²/day temozolomide 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: 100 mg/m²/Day Temozolomide	19

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: 100 mg/m²/Day Temozolomide	14400	23	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: 100 mg/m²/Day Temozolomide	12200	44	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
23
value
14400
title
Cycle 1, Day 1
categories
measurements
group Id
OG000
spread
44
value
12200
title
Cycle 2, Day 1

denoms

counts
group Id
OG000
value
19
units
Participants

description

PK: AUC0-tlast was reported.

dispersion Type

Geometric Coefficient of Variation

groups

description
All part A participants who received 100 mg/m²/day temozolomide were included under this arm.
id
OG000
title
Part A: 100 mg/m²/Day Temozolomide

param Type

GEOMETRIC_LEAST_SQUARES_MEAN

population Description

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

reporting Status

POSTED

time Frame

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 Temozolomide in Part A

type

PRIMARY

unit Of Measure

ng*h/mL

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Preserved source evidence · Not medical advice