NCT00697346 · OUTCOME

AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) 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*hr
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1 Days 1 predose and at multiple timepoints (up to 12 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 30 mg ECT BID 7D

Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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 40 mg ECT BID 7D

alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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 50 mg ECT BID 7D

Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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

Group	Source count
Alisertib 30 mg ECT BID 7D	3
Alisertib 40 mg ECT BID 7D	9
Alisertib 50 mg ECT BID 7D	9

Reported measurements

Source class 1

Values in nM*hr · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Alisertib 30 mg ECT BID 7D	5518	18.3	Not reported	Not reported	Not reported
Alisertib 40 mg ECT BID 7D	7095	42.5	Not reported	Not reported	Not reported
Alisertib 50 mg ECT BID 7D	9732	48.5	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
18.3
value
5518
group Id
OG001
spread
42.5
value
7095
group Id
OG002
spread
48.5
value
9732

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
9
group Id
OG002
value
9
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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 30 mg ECT BID 7D
description
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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
OG001
title
Alisertib 40 mg ECT BID 7D
description
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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 50 mg ECT BID 7D

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. Here number of participants analyzed were participants evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Cycle 1 Days 1 predose and at multiple timepoints (up to 12 hours) postdose

title

AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1

type

PRIMARY

unit Of Measure

nM*hr

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

Preserved source evidence · Not medical advice