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NCT00697346 · OUTCOME

Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 1

Study of MLN8237 in Participants With Advanced Hematological Malignancies · Source last updated 2019-05-31

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

Measure
GEOMETRIC_MEAN
Unit
nM
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose

Analysis population: PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.

Groups in this outcome

Alisertib 40 mg ECT QD 14D

Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).

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

Analysis denominator · Participants

GroupSource count
Alisertib 40 mg ECT QD 14D6

Reported measurements

Source class 1
Values in nM · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alisertib 40 mg ECT QD 14D122741.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.3
        value
        1227
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
    id
    OG000
    title
    Alisertib 40 mg ECT QD 14D
param Type
GEOMETRIC_MEAN
population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
title
Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 1
type
PRIMARY
unit Of Measure
nM

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice