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NCT02102490 · OUTCOME

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20

A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread · Source last updated 2020-01-21

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

What was measured

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

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

Groups in this outcome

Abemaciclib

200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.

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

Analysis denominator · Participants

GroupSource count
Abemaciclib132

Reported measurements

Abemaciclib
Values in Nanograms*hour/milliliters (ng*h/mL)] · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Abemaciclib351038.0Not reportedNot reportedNot reported
M2
Values in Nanograms*hour/milliliters (ng*h/mL)] · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Abemaciclib162055.0Not reportedNot reportedNot reported
M20
Values in Nanograms*hour/milliliters (ng*h/mL)] · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Abemaciclib275055.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.0
        value
        3510
    title
    Abemaciclib
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.0
        value
        1620
    title
    M2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.0
        value
        2750
    title
    M20
denoms
  1. counts
    1. group Id
      OG000
      value
      132
    units
    Participants
description
Area Under the 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
  1. description
    200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
    id
    OG000
    title
    Abemaciclib
param Type
GEOMETRIC_MEAN
population Description
All enrolled participants who received at least one dose of study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 pharmacokinetic (PK) data.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
title
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and 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