NCT02046070 · OUTCOME

AUCtau: Area Under the Concentration-time Curve During a Dosing Interval for Ixazomib in RRMM Participants

Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma · Source last updated 2019-07-17

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

Measure: MEAN
Unit: hr*ng/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose

Analysis population: PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.

Groups in this outcome

Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.

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 + CYC 300 mg/m^2 + DEX 40 mg (RRMM)	7

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)	6

Values in hr*ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)	518.167	78.8274	Not reported	Not reported	Not reported

Cycle 1 Day 15

Analysis denominator · Participants

Group	Source count
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)	7

Values in hr*ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)	1241.000	657.4978	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
78.8274
value
518.167
denoms
counts
group Id
OG000
value
6
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
657.4978
value
1241.000
denoms
counts
group Id
OG000
value
7
units
Participants
title
Cycle 1 Day 15

denoms

counts
group Id
OG000
value
7
units
Participants

dispersion Type

Standard Deviation

groups

description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.
id
OG000
title
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)

param Type

MEAN

population Description

PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.

reporting Status

POSTED

time Frame

Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose

title

AUCtau: Area Under the Concentration-time Curve During a Dosing Interval for Ixazomib in RRMM Participants

type

SECONDARY

unit Of Measure

hr*ng/mL

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

Preserved source evidence · Not medical advice