NCT01318902 · OUTCOME

TEmax: Time to Maximum Observed Effect (Emax) of Whole Blood 20S Proteasome Inhibition 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: MEDIAN
Unit: hours
Interval / dispersion: Full Range
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

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg	1.0000	Not reported	0.500	6.000	Not reported

Cycle 1, Day 15

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg	1.0300	Not reported	0.500	6.020	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.500
upper Limit
6.000
value
1.0000
title
Cycle 1, Day 1
categories
measurements
group Id
OG000
lower Limit
0.500
upper Limit
6.020
value
1.0300
title
Cycle 1, Day 15

denoms

counts
group Id
OG000
value
15
units
Participants

dispersion Type

Full Range

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

MEDIAN

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

TEmax: Time to Maximum Observed Effect (Emax) of Whole Blood 20S Proteasome Inhibition for Ixazomib

type

SECONDARY

unit Of Measure

hours

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

Preserved source evidence · Not medical advice