NCT02107703 · OUTCOME

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer · Source last updated 2025-10-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: Nanograms*hour/milliliters (ng*h/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose

What was measured

Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) was evaluated for Abemaciclib and Metabolites M2 and M20.

Analysis population: All randomized participants who received at least one dose of 150 mg study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 PK data.

Groups in this outcome

Abemaciclib + Fulvestrant

Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.

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
Abemaciclib + Fulvestrant	326

Reported measurements

Abemaciclib

Values in Nanograms*hour/milliliters (ng*h/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Abemaciclib + Fulvestrant	2960	32.2	Not reported	Not reported	Not reported

Values in Nanograms*hour/milliliters (ng*h/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Abemaciclib + Fulvestrant	1640	70.2	Not reported	Not reported	Not reported

M20

Values in Nanograms*hour/milliliters (ng*h/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Abemaciclib + Fulvestrant	2870	69.6	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
32.2
value
2960
title
Abemaciclib
categories
measurements
group Id
OG000
spread
70.2
value
1640
title
M2
categories
measurements
group Id
OG000
spread
69.6
value
2870
title
M20

denoms

counts
group Id
OG000
value
326
units
Participants

description

Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) was evaluated for Abemaciclib and Metabolites M2 and M20.

dispersion Type

Geometric Coefficient of Variation

groups

description
Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
id
OG000
title
Abemaciclib + Fulvestrant

param Type

GEOMETRIC_MEAN

population Description

All randomized participants who received at least one dose of 150 mg study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 PK data.

reporting Status

POSTED

time Frame

Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose

title

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20

type

SECONDARY

unit Of Measure

Nanograms*hour/milliliters (ng*h/mL)

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

Preserved source evidence · Not medical advice