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NCT00697346 · OUTCOME

Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) 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
ratio
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 were participants evaluable for this outcome measure.

Groups in this outcome

Alisertib 35 mg PIC QD 14D

Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (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 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).

Alisertib 45 mg PIC QD 14D

Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).

Alisertib 65 mg PIC QD 14D

Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (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 6 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 35 mg PIC QD 14D2
Alisertib 45 mg PIC QD 14D5
Alisertib 65 mg PIC QD 14D6

Reported measurements

Source class 1
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Alisertib 35 mg PIC QD 14D2.40.001.94.0Not reported
Alisertib 45 mg PIC QD 14D1.50.51.14.0Not reported
Alisertib 65 mg PIC QD 14D1.91.61.96.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        spread
        0.00
        upper Limit
        4.0
        value
        2.4
      2. group Id
        OG001
        lower Limit
        1.1
        spread
        0.5
        upper Limit
        4.0
        value
        1.5
      3. group Id
        OG002
        lower Limit
        1.9
        spread
        1.6
        upper Limit
        6.0
        value
        1.9
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      6
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (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 6 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 35 mg PIC QD 14D
  2. description
    Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
    id
    OG001
    title
    Alisertib 45 mg PIC QD 14D
  3. description
    Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (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 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
    id
    OG002
    title
    Alisertib 65 mg PIC 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 were 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
Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14
type
PRIMARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice