NCT01318902 · OUTCOME

AUE0-168: Area Under Effect Curve of Whole Blood 20S Proteasome Inhibition From Zero to Concentration at 168 Hours for Ixazomib

Study of Oral Ixazomib in Adult Participants With Relapsed or Refractory Light Chain Amyloidosis · Source last updated 2020-04-01

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

Measure: MEAN
Unit: hr*percentage of inhibition
Interval / dispersion: Standard Deviation
Time frame: Cycle 1: Day 1 (MTD cohort participants only, 4.0 mg) and Day 15 (all participants enrolled in the study): predose (within 1 hour (hr) before dosing), and postdose at multiple timepoints up to 168 hr

Analysis population: PD analysis population: all participants who received at least 1 dose of ixazomib and had whole blood 20S proteasome inhibition-time data and dosing data to permit calculation of PD parameters. Data was only collected for ixazomib 4.0 mg arm group. Number analyzed is number of participants with evaluable data at given time-point.

Groups in this outcome

Ixazomib 4.0 mg

Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1 and 15 during each 28-day treatment cycle for all the participants from dose escalation and expansion cohorts were evaluated in this arm group. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.

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
Ixazomib 4.0 mg	15

Reported measurements

Cycle 1, Day 1

Analysis denominator · Participants

Group	Source count
Ixazomib 4.0 mg	14

Values in hr*percentage of inhibition · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg	3333.6	1377.24	Not reported	Not reported	Not reported

Cycle 1, Day 15

Analysis denominator · Participants

Group	Source count
Ixazomib 4.0 mg	10

Values in hr*percentage of inhibition · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg	3943.0	2322.96	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1377.24
value
3333.6
denoms
counts
group Id
OG000
value
14
units
Participants
title
Cycle 1, Day 1
categories
measurements
group Id
OG000
spread
2322.96
value
3943.0
denoms
counts
group Id
OG000
value
10
units
Participants
title
Cycle 1, Day 15

denoms

counts
group Id
OG000
value
15
units
Participants

dispersion Type

Standard Deviation

groups

description
Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1 and 15 during each 28-day treatment cycle for all the participants from dose escalation and expansion cohorts were evaluated in this arm group. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
id
OG000
title
Ixazomib 4.0 mg

param Type

MEAN

population Description

PD analysis population: all participants who received at least 1 dose of ixazomib and had whole blood 20S proteasome inhibition-time data and dosing data to permit calculation of PD parameters. Data was only collected for ixazomib 4.0 mg arm group. Number analyzed is number of participants with evaluable data at given time-point.

reporting Status

POSTED

time Frame

Cycle 1: Day 1 (MTD cohort participants only, 4.0 mg) and Day 15 (all participants enrolled in the study): predose (within 1 hour (hr) before dosing), and postdose at multiple timepoints up to 168 hr

title

AUE0-168: Area Under Effect Curve of Whole Blood 20S Proteasome Inhibition From Zero to Concentration at 168 Hours for Ixazomib

type

SECONDARY

unit Of Measure

hr*percentage of inhibition

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

Preserved source evidence · Not medical advice