NCT01217957 · OUTCOME

Phase 1: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) 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: MEDIAN
Unit: hours
Interval / dispersion: Full Range
Time frame: Cycle 1, Days 1 and 15

What was measured

Tmax: Time to reach the first maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax, obtained directly from the plasma concentration-time curve.

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 data available.

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 for 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 for 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 for 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 hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone	1.020	Not reported	NA	NA	Not calculated for 1 participant.
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone	1.520	Not reported	1.00	8.00	Not reported
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone	1.060	Not reported	0.50	1.08	Not reported
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone	0.250	Not reported	NA	NA	Not calculated for 1 participant.

Day 15 (n=2, 3, 4, 1)

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone	4.165	Not reported	1.05	7.28	Not reported
Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone	1.000	Not reported	0.98	2.03	Not reported
Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone	1.015	Not reported	1.00	2.02	Not reported
Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone	2.000	Not reported	NA	NA	Not calculated for 1 participant.

Complete source fields

classes

categories
measurements
comment
Not calculated for 1 participant.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
1.020
group Id
OG001
lower Limit
1.00
upper Limit
8.00
value
1.520
group Id
OG002
lower Limit
0.50
upper Limit
1.08
value
1.060
comment
Not calculated for 1 participant.
group Id
OG003
lower Limit
NA
upper Limit
NA
value
0.250
title
Day 1 (n=1, 3, 4, 1)
categories
measurements
group Id
OG000
lower Limit
1.05
upper Limit
7.28
value
4.165
group Id
OG001
lower Limit
0.98
upper Limit
2.03
value
1.000
group Id
OG002
lower Limit
1.00
upper Limit
2.02
value
1.015
comment
Not calculated for 1 participant.
group Id
OG003
lower Limit
NA
upper Limit
NA
value
2.000
title
Day 15 (n=2, 3, 4, 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

Tmax: Time to reach the first maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax, obtained directly from the plasma concentration-time curve.

dispersion Type

Full Range

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 for 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 for 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 for 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

MEDIAN

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 data available.

reporting Status

POSTED

time Frame

Cycle 1, Days 1 and 15

title

Phase 1: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib

type

SECONDARY

unit Of Measure

hours

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Preserved source evidence · Not medical advice