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NCT00697346 · OUTCOME

CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14

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
MEAN
Unit
L/h
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 14 predose and at multiple timepoints (up to 8 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. Here number of participants analyzed are participants evaluable for this outcome measure.

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 14D1

Reported measurements

Source class 1
Values in L/h · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Alisertib 40 mg ECT QD 14D2.5NA2.06.1Standard deviation is not estimable for 1 participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Standard deviation is not estimable for 1 participant.
        group Id
        OG000
        lower Limit
        2.0
        spread
        NA
        upper Limit
        6.1
        value
        2.5
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
dispersion Type
Standard Deviation
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
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. Here number of participants analyzed are participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
title
CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14
type
PRIMARY
unit Of Measure
L/h

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

Preserved source evidence · Not medical advice