NCT04238819 · OUTCOME

PK: AUC0-tlast of Temozolomide 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_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 B participants in 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 B: 100 mg/m²/Day Temozolomide

All part B participants who received 100 mg/m²/day temozolomide were included under this arm.

Part B: 150 mg/m²/Day Temozolomide

All part B participants who received 150 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 B: 100 mg/m²/Day Temozolomide	13
Part B: 150 mg/m²/Day Temozolomide	11

Reported measurements

Cycle 1, Day 1

Analysis denominator · Participants

Group	Source count
Part B: 100 mg/m²/Day Temozolomide	13
Part B: 150 mg/m²/Day Temozolomide	11

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part B: 100 mg/m²/Day Temozolomide	15800	19	Not reported	Not reported	Not reported
Part B: 150 mg/m²/Day Temozolomide	24300	13	Not reported	Not reported	Not reported

Cycle 2, Day 1

Analysis denominator · Participants

Group	Source count
Part B: 100 mg/m²/Day Temozolomide	13
Part B: 150 mg/m²/Day Temozolomide	10

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part B: 100 mg/m²/Day Temozolomide	15700	21	Not reported	Not reported	Not reported
Part B: 150 mg/m²/Day Temozolomide	21100	43	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
19
value
15800
group Id
OG001
spread
13
value
24300
denoms
counts
group Id
OG000
value
13
group Id
OG001
value
11
units
Participants
title
Cycle 1, Day 1
categories
measurements
group Id
OG000
spread
21
value
15700
group Id
OG001
spread
43
value
21100
denoms
counts
group Id
OG000
value
13
group Id
OG001
value
10
units
Participants
title
Cycle 2, Day 1

denoms

counts
group Id
OG000
value
13
group Id
OG001
value
11
units
Participants

description

PK: AUC0-tlast was reported.

dispersion Type

Geometric Coefficient of Variation

groups

description
All part B participants who received 100 mg/m²/day temozolomide were included under this arm.
id
OG000
title
Part B: 100 mg/m²/Day Temozolomide
description
All part B participants who received 150 mg/m²/day temozolomide were included under this arm.
id
OG001
title
Part B: 150 mg/m²/Day Temozolomide

param Type

GEOMETRIC_LEAST_SQUARES_MEAN

population Description

All Part B participants in 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 B

type

PRIMARY

unit Of Measure

ng*h/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice