Skip to content
← Full study record

NCT00932698 · OUTCOME

Cmax: Maximum Observed Plasma Concentration for Ixazomib

Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma · Source last updated 2019-08-07

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
Standard Deviation
Time frame
Cycle 1, Days 1 and 11: Predose and at multiple time points (up to 264 hours) postdose

Analysis population: PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.

Groups in this outcome

Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2

Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).

Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2

Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).

Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2

Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).

Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2

Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).

Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2

Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).

Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2

Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).

Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2

Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).

Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2

Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).

Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2

Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).

Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2

Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determine the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor.

Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2

Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).

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

Analysis denominator · Participants

GroupSource count
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^23
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^23
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^22
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^22
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^23
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^26
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^23
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^217
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^29
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^26
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^21

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^23
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^22
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^22
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^22
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^23
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^26
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^23
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^214
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^29
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^26
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^21
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^22.1200.3974Not reportedNot reportedNot reported
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^210.1902.5597Not reportedNot reportedNot reported
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^222.20011.3137Not reportedNot reportedNot reported
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^229.00024.1831Not reportedNot reportedNot reported
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^221.10010.1237Not reportedNot reportedNot reported
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^268.16734.7876Not reportedNot reportedNot reported
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2117.93367.1924Not reportedNot reportedNot reported
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^258.90036.1337Not reportedNot reportedNot reported
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^259.34341.9853Not reportedNot reportedNot reported
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^285.60058.8496Not reportedNot reportedNot reported
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^226.600NANot reportedNot reportedSD was not calculated for 1 participant.
Day 11

Analysis denominator · Participants

GroupSource count
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^23
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^23
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^22
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^22
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^23
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^25
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^22
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^214
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^27
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^25
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^21
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^22.8371.5051Not reportedNot reportedNot reported
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^28.8575.5598Not reportedNot reportedNot reported
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^231.65015.2028Not reportedNot reportedNot reported
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^256.50014.1421Not reportedNot reportedNot reported
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2101.10071.3597Not reportedNot reportedNot reported
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^285.42030.7632Not reportedNot reportedNot reported
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2105.45041.7900Not reportedNot reportedNot reported
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^259.87132.5851Not reportedNot reportedNot reported
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^261.80024.8780Not reportedNot reportedNot reported
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2109.66027.5668Not reportedNot reportedNot reported
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^227.200NANot reportedNot reportedSD was not calculated for 1 participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.3974
        value
        2.120
      2. group Id
        OG001
        spread
        2.5597
        value
        10.190
      3. group Id
        OG002
        spread
        11.3137
        value
        22.200
      4. group Id
        OG003
        spread
        24.1831
        value
        29.000
      5. group Id
        OG004
        spread
        10.1237
        value
        21.100
      6. group Id
        OG005
        spread
        34.7876
        value
        68.167
      7. group Id
        OG006
        spread
        67.1924
        value
        117.933
      8. group Id
        OG007
        spread
        36.1337
        value
        58.900
      9. group Id
        OG008
        spread
        41.9853
        value
        59.343
      10. group Id
        OG009
        spread
        58.8496
        value
        85.600
      11. comment
        SD was not calculated for 1 participant.
        group Id
        OG010
        spread
        NA
        value
        26.600
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        6
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        14
      9. group Id
        OG008
        value
        9
      10. group Id
        OG009
        value
        6
      11. group Id
        OG010
        value
        1
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.5051
        value
        2.837
      2. group Id
        OG001
        spread
        5.5598
        value
        8.857
      3. group Id
        OG002
        spread
        15.2028
        value
        31.650
      4. group Id
        OG003
        spread
        14.1421
        value
        56.500
      5. group Id
        OG004
        spread
        71.3597
        value
        101.100
      6. group Id
        OG005
        spread
        30.7632
        value
        85.420
      7. group Id
        OG006
        spread
        41.7900
        value
        105.450
      8. group Id
        OG007
        spread
        32.5851
        value
        59.871
      9. group Id
        OG008
        spread
        24.8780
        value
        61.800
      10. group Id
        OG009
        spread
        27.5668
        value
        109.660
      11. comment
        SD was not calculated for 1 participant.
        group Id
        OG010
        spread
        NA
        value
        27.200
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        14
      9. group Id
        OG008
        value
        7
      10. group Id
        OG009
        value
        5
      11. group Id
        OG010
        value
        1
      units
      Participants
    title
    Day 11
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      17
    9. group Id
      OG008
      value
      9
    10. group Id
      OG009
      value
      6
    11. group Id
      OG010
      value
      1
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
    id
    OG000
    title
    Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
  2. description
    Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
    id
    OG001
    title
    Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
  3. description
    Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
    id
    OG002
    title
    Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
  4. description
    Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
    id
    OG003
    title
    Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
  5. description
    Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
    id
    OG004
    title
    Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
  6. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
    id
    OG005
    title
    Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
  7. description
    Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
    id
    OG006
    title
    Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
  8. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
    id
    OG007
    title
    Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
  9. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
    id
    OG008
    title
    Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
  10. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determine the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor.
    id
    OG009
    title
    Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
  11. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
    id
    OG010
    title
    Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
param Type
MEAN
population Description
PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.
reporting Status
POSTED
time Frame
Cycle 1, Days 1 and 11: Predose and at multiple time points (up to 264 hours) postdose
title
Cmax: Maximum Observed Plasma Concentration for Ixazomib
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice