NCT01830816 · OUTCOME

Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib

Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Participants With Normal Renal Function or Severe Renal Impairment · Source last updated 2019-06-10

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

Measure: GEOMETRIC_MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose

Analysis population: Pharmacokinetic (PK) evaluable population was defined as participants who received protocol-specified single dose in Part A; did not receive any excluded concomitant medications through the completion of PK sampling; and had sufficient concentration-time data to permit reliable estimation of PK parameters by non-compartmental analysis methods.

Groups in this outcome

Normal Renal Function: Ixazomib

Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.

Severe Renal Impairment: Ixazomib

End-stage Renal Disease: Ixazomib

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
Normal Renal Function: Ixazomib	18
Severe Renal Impairment: Ixazomib	14
End-stage Renal Disease: Ixazomib	6

Reported measurements

Source class 1

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Normal Renal Function: Ixazomib	0.300	0.247944	Not reported	Not reported	Not reported
Severe Renal Impairment: Ixazomib	0.478	0.599519	Not reported	Not reported	Not reported
End-stage Renal Disease: Ixazomib	0.213	0.136696	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.247944
value
0.300
group Id
OG001
spread
0.599519
value
0.478
group Id
OG002
spread
0.136696
value
0.213

denoms

counts
group Id
OG000
value
18
group Id
OG001
value
14
group Id
OG002
value
6
units
Participants

dispersion Type

Standard Deviation

groups

description
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
id
OG000
title
Normal Renal Function: Ixazomib
description
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
id
OG001
title
Severe Renal Impairment: Ixazomib
description
Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
id
OG002
title
End-stage Renal Disease: Ixazomib

param Type

GEOMETRIC_MEAN

population Description

Pharmacokinetic (PK) evaluable population was defined as participants who received protocol-specified single dose in Part A; did not receive any excluded concomitant medications through the completion of PK sampling; and had sufficient concentration-time data to permit reliable estimation of PK parameters by non-compartmental analysis methods.

reporting Status

POSTED

time Frame

Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose

title

Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib

type

PRIMARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice