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NCT02246621 · OUTCOME

Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer · Source last updated 2026-02-03

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

Measure
GEOMETRIC_MEAN
Unit
nanogram*hours/milliliter (ng*h/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose

What was measured

Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity \[AUC(0-∞)\] of Abemaciclib and Its Metabolites M2 and M20

Analysis population: All randomized participants who received at least one dose of study drug with evaluable PK data.

Groups in this outcome

Abemaciclib + NSAI

150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).

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

Analysis denominator · Participants

GroupSource count
Abemaciclib + NSAI322

Reported measurements

Abemaciclib
Values in nanogram*hours/milliliter (ng*h/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Abemaciclib + NSAI336036.6Not reportedNot reportedNot reported
M2
Values in nanogram*hours/milliliter (ng*h/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Abemaciclib + NSAI129075.8Not reportedNot reportedNot reported
M20
Values in nanogram*hours/milliliter (ng*h/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Abemaciclib + NSAI230074.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.6
        value
        3360
    title
    Abemaciclib
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        75.8
        value
        1290
    title
    M2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        74.4
        value
        2300
    title
    M20
denoms
  1. counts
    1. group Id
      OG000
      value
      322
    units
    Participants
description
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity \[AUC(0-∞)\] of Abemaciclib and Its Metabolites M2 and M20
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
    id
    OG000
    title
    Abemaciclib + NSAI
param Type
GEOMETRIC_MEAN
population Description
All randomized participants who received at least one dose of study drug with evaluable PK data.
reporting Status
POSTED
time Frame
Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
title
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20
type
SECONDARY
unit Of Measure
nanogram*hours/milliliter (ng*h/mL)

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

Preserved source evidence · Not medical advice