NCT01217957 · OUTCOME

Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib

A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-03-14

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

Measure: GEOMETRIC_MEAN
Unit: hr*ng/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 1, Days 1 and 15

What was measured

AUC(0-168) is a measure of the area under the plasma concentration-time curve from time 0 to 168 hours postdose for Ixazomib.

Analysis population: The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.

Groups in this outcome

Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone

In phase 1, ixazomib 1.68 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone

In phase 1, ixazomib 2.23 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone

In phase 1, ixazomib 2.97 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone

In phase 1, ixazomib 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

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
Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone	2
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone	3
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone	4
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone	1

Reported measurements

Day 1 (n=1, 3, 4, 1)

Values in hr*ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone	NA	NA	Not reported	Not reported	Not calculated for 1 participant.
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone	587.667	350.1861	Not reported	Not reported	Not reported
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone	923.484	156.2679	Not reported	Not reported	Not reported
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone	NA	NA	Not reported	Not reported	Not calculated for 1 participant.

Day 15 (n=2, 3, 3, 1)

Values in hr*ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone	834.608	NA	Not reported	Not reported	Not calculated for 2 participants.
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone	1083.998	104.0256	Not reported	Not reported	Not reported
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone	1831.324	262.7420	Not reported	Not reported	Not reported
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone	NA	NA	Not reported	Not reported	Not calculated for 1 participant.

Complete source fields

classes

categories
measurements
comment
Not calculated for 1 participant.
group Id
OG000
spread
NA
value
NA
group Id
OG001
spread
350.1861
value
587.667
group Id
OG002
spread
156.2679
value
923.484
comment
Not calculated for 1 participant.
group Id
OG003
spread
NA
value
NA
title
Day 1 (n=1, 3, 4, 1)
categories
measurements
comment
Not calculated for 2 participants.
group Id
OG000
spread
NA
value
834.608
group Id
OG001
spread
104.0256
value
1083.998
group Id
OG002
spread
262.7420
value
1831.324
comment
Not calculated for 1 participant.
group Id
OG003
spread
NA
value
NA
title
Day 15 (n=2, 3, 3, 1)

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
4
group Id
OG003
value
1
units
Participants

description

AUC(0-168) is a measure of the area under the plasma concentration-time curve from time 0 to 168 hours postdose for Ixazomib.

dispersion Type

Standard Deviation

groups

description
In phase 1, ixazomib 1.68 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
OG000
title
Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone
description
In phase 1, ixazomib 2.23 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
OG001
title
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone
description
In phase 1, ixazomib 2.97 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
OG002
title
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone
description
In phase 1, ixazomib 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
OG003
title
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone

param Type

GEOMETRIC_MEAN

population Description

The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.

reporting Status

POSTED

time Frame

Cycle 1, Days 1 and 15

title

Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib

type

SECONDARY

unit Of Measure

hr*ng/mL

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Preserved source evidence · Not medical advice