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NCT00963820 · OUTCOME

Emax: Maximum Inhibition

Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple Myeloma · Source last updated 2018-01-10

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

Measure
MEAN
Unit
Percentage of inhibition
Interval / dispersion
Standard Deviation
Time frame
Days 1 and 15 of Cycle 1

What was measured

A Whole Blood 20S Proteasome Inhibition Parameter. There were no subjects in the Pharmacodynamic (PD) Analysis Set for the 2.23 mg/m\^2 cohort, so PD tables do not include that arm.

Analysis population: PD analysis Population included all participants who had sufficient dosing data to calculate PD parameters

Groups in this outcome

0.24 mg/m^2

Ixazomib citrate, 0.24 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

0.48 mg/m^2

Ixazomib citrate, 0.48 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

0.80 mg/m^2

Ixazomib citrate, 0.80 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

1.20 mg/m^2

Ixazomib citrate, 1.20 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

1.68 mg/m^2

Ixazomib citrate, 1.68 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

2.23 mg/m^2

Ixazomib citrate, 2.23 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

2.97 mg/m^2

Ixazomib citrate, 2.97 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

3.95 mg/m^2

Ixazomib citrate, 3.95 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

Relapsed and Refractory (RR)

Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

VELCADE-relapsed (VR)

Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

PI naïve

Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

Carfilzomib

Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.

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

Analysis denominator · Participants

GroupSource count
0.24 mg/m^22
0.48 mg/m^22
0.80 mg/m^23
1.20 mg/m^23
1.68 mg/m^23
2.23 mg/m^21
2.97 mg/m^25
3.95 mg/m^25
Relapsed and Refractory (RR)10
VELCADE-relapsed (VR)8
PI naïve5
Carfilzomib3

Reported measurements

Source class 1
Values in Percentage of inhibition · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.24 mg/m^2NANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
0.48 mg/m^2NANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
0.80 mg/m^2NANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
1.20 mg/m^2NANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
1.68 mg/m^2NANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
2.23 mg/m^2NANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
2.97 mg/m^2NANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
3.95 mg/m^2NANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
Relapsed and Refractory (RR)NANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
VELCADE-relapsed (VR)NANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
PI naïveNANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
CarfilzomibNANANot reportedNot reportedDue to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG002
        spread
        NA
        value
        NA
      4. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG003
        spread
        NA
        value
        NA
      5. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG004
        spread
        NA
        value
        NA
      6. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG005
        spread
        NA
        value
        NA
      7. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG006
        spread
        NA
        value
        NA
      8. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG007
        spread
        NA
        value
        NA
      9. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG008
        spread
        NA
        value
        NA
      10. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG009
        spread
        NA
        value
        NA
      11. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG010
        spread
        NA
        value
        NA
      12. comment
        Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported
        group Id
        OG011
        spread
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      5
    9. group Id
      OG008
      value
      10
    10. group Id
      OG009
      value
      8
    11. group Id
      OG010
      value
      5
    12. group Id
      OG011
      value
      3
    units
    Participants
description
A Whole Blood 20S Proteasome Inhibition Parameter. There were no subjects in the Pharmacodynamic (PD) Analysis Set for the 2.23 mg/m\^2 cohort, so PD tables do not include that arm.
dispersion Type
Standard Deviation
groups
  1. description
    Ixazomib citrate, 0.24 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG000
    title
    0.24 mg/m^2
  2. description
    Ixazomib citrate, 0.48 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG001
    title
    0.48 mg/m^2
  3. description
    Ixazomib citrate, 0.80 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG002
    title
    0.80 mg/m^2
  4. description
    Ixazomib citrate, 1.20 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG003
    title
    1.20 mg/m^2
  5. description
    Ixazomib citrate, 1.68 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG004
    title
    1.68 mg/m^2
  6. description
    Ixazomib citrate, 2.23 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG005
    title
    2.23 mg/m^2
  7. description
    Ixazomib citrate, 2.97 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG006
    title
    2.97 mg/m^2
  8. description
    Ixazomib citrate, 3.95 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG007
    title
    3.95 mg/m^2
  9. description
    Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG008
    title
    Relapsed and Refractory (RR)
  10. description
    Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG009
    title
    VELCADE-relapsed (VR)
  11. description
    Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG010
    title
    PI naïve
  12. description
    Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
    id
    OG011
    title
    Carfilzomib
param Type
MEAN
population Description
PD analysis Population included all participants who had sufficient dosing data to calculate PD parameters
reporting Status
POSTED
time Frame
Days 1 and 15 of Cycle 1
title
Emax: Maximum Inhibition
type
SECONDARY
unit Of Measure
Percentage of inhibition

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

Preserved source evidence · Not medical advice