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NCT01318902 · OUTCOME

Ctrough: Plasma Concentration Immediately Prior to Dosing 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
MEAN
Unit
ng/mL
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: PK analysis population included all participants who received at least 1 dose of ixazomib and had sufficient ixazomib concentration-time data and dosing data to permit calculation of ixazomib plasma PK parameters. Number analyzed is the number of participants with evaluable data at the 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.

Ixazomib 5.5 mg

Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone was added on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. The maximum duration of treatment was up to 12 cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ixazomib 4.0 mg20
Ixazomib 5.5 mg2

Reported measurements

Cycle 1, Day 1

Analysis denominator · Participants

GroupSource count
Ixazomib 4.0 mg15
Ixazomib 5.5 mg0
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg2.1539Not reported0.00014.400Not reported
Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Ixazomib 4.0 mg15
Ixazomib 5.5 mg2
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg2.9140Not reported1.0106.750Not reported
Ixazomib 5.5 mg5.3300Not reported4.4106.250Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.000
        upper Limit
        14.400
        value
        2.1539
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Cycle 1, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.010
        upper Limit
        6.750
        value
        2.9140
      2. group Id
        OG001
        lower Limit
        4.410
        upper Limit
        6.250
        value
        5.3300
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Cycle 1, Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      2
    units
    Participants
dispersion Type
Full Range
groups
  1. 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
  2. description
    Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone was added on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. The maximum duration of treatment was up to 12 cycles.
    id
    OG001
    title
    Ixazomib 5.5 mg
param Type
MEAN
population Description
PK analysis population included all participants who received at least 1 dose of ixazomib and had sufficient ixazomib concentration-time data and dosing data to permit calculation of ixazomib plasma PK parameters. Number analyzed is the number of participants with evaluable data at the 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
Ctrough: Plasma Concentration Immediately Prior to Dosing for Ixazomib
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice