NCT00697346 · OUTCOME

Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) 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 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).

Alisertib 90 mg PIC QD 14D

Alisertib 90 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 5 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

Group	Source count
Alisertib 35 mg PIC QD 14D	3
Alisertib 45 mg PIC QD 14D	6
Alisertib 65 mg PIC QD 14D	7
Alisertib 90 mg PIC QD 14D	2

Reported measurements

Source class 1

Values in nM · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Alisertib 35 mg PIC QD 14D	726.5	34.8	Not reported	Not reported	Not reported
Alisertib 45 mg PIC QD 14D	1637.0	58.0	Not reported	Not reported	Not reported
Alisertib 65 mg PIC QD 14D	1773.4	44.3	Not reported	Not reported	Not reported
Alisertib 90 mg PIC QD 14D	2497.4	24.3	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
34.8
value
726.5
group Id
OG001
spread
58.0
value
1637.0
group Id
OG002
spread
44.3
value
1773.4
group Id
OG003
spread
24.3
value
2497.4

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
7
group Id
OG003
value
2
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

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
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
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
description
Alisertib 90 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 5 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
id
OG003
title
Alisertib 90 mg PIC 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 Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1

type

PRIMARY

unit Of Measure

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Preserved source evidence · Not medical advice