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NCT02939183 · OUTCOME

Time to Cmax (Tmax) of Oprozomib

Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma · Source last updated 2024-09-26

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 8 and 22: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose. GR only: cycle 1 day 8: 8 hours post-dose

What was measured

The median Tmax of oprozomib is presented following dosing on cycle 1 day 8 and cycle 1 day 22 for the IR and GR oprozomib formulations.

Analysis population: Participants in the PK analysis set with data available at each time point. The PK analysis set included participants for whom at least 1 PK parameter could be adequately estimated, excluding roll-over participants.

Groups in this outcome

Oprozomib IR 150 mg/Day + Dexamethsone

In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.

Oprozomib GR 150 mg/Day + Dexamethasone

In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.

Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Oprozomib IR 150 mg/Day + Dexamethsone3
Oprozomib GR 150 mg/Day + Dexamethasone6
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone3
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone3
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone7
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone5
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone10
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone7

Reported measurements

Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Oprozomib IR 150 mg/Day + Dexamethsone3
Oprozomib GR 150 mg/Day + Dexamethasone4
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone3
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone3
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone7
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone5
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone10
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone7
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Oprozomib IR 150 mg/Day + Dexamethsone1.0Not reported0.931.9Not reported
Oprozomib GR 150 mg/Day + Dexamethasone2.0Not reported2.04.0Not reported
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone2.0Not reported0.502.0Not reported
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone5.8Not reported3.96.0Not reported
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone2.0Not reported0.456.0Not reported
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone2.0Not reported1.15.8Not reported
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone1.5Not reported0.474.2Not reported
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone1.3Not reported0.425.8Not reported
Cycle 1 Day 22

Analysis denominator · Participants

GroupSource count
Oprozomib IR 150 mg/Day + Dexamethsone3
Oprozomib GR 150 mg/Day + Dexamethasone6
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone1
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone3
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone4
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone4
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone10
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone4
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Oprozomib IR 150 mg/Day + Dexamethsone1.0Not reported0.982.0Not reported
Oprozomib GR 150 mg/Day + Dexamethasone3.0Not reported1.96.0Not reported
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone1.0Not reported1.01.0Not reported
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone4.1Not reported3.76.0Not reported
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone1.3Not reported0.452.0Not reported
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone4.8Not reported2.06.0Not reported
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone0.98Not reported0.422.2Not reported
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone0.75Not reported0.501.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.93
        upper Limit
        1.9
        value
        1.0
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        4.0
        value
        2.0
      3. group Id
        OG002
        lower Limit
        0.50
        upper Limit
        2.0
        value
        2.0
      4. group Id
        OG003
        lower Limit
        3.9
        upper Limit
        6.0
        value
        5.8
      5. group Id
        OG004
        lower Limit
        0.45
        upper Limit
        6.0
        value
        2.0
      6. group Id
        OG005
        lower Limit
        1.1
        upper Limit
        5.8
        value
        2.0
      7. group Id
        OG006
        lower Limit
        0.47
        upper Limit
        4.2
        value
        1.5
      8. group Id
        OG007
        lower Limit
        0.42
        upper Limit
        5.8
        value
        1.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        10
      8. group Id
        OG007
        value
        7
      units
      Participants
    title
    Cycle 1 Day 8
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.98
        upper Limit
        2.0
        value
        1.0
      2. group Id
        OG001
        lower Limit
        1.9
        upper Limit
        6.0
        value
        3.0
      3. group Id
        OG002
        lower Limit
        1.0
        upper Limit
        1.0
        value
        1.0
      4. group Id
        OG003
        lower Limit
        3.7
        upper Limit
        6.0
        value
        4.1
      5. group Id
        OG004
        lower Limit
        0.45
        upper Limit
        2.0
        value
        1.3
      6. group Id
        OG005
        lower Limit
        2.0
        upper Limit
        6.0
        value
        4.8
      7. group Id
        OG006
        lower Limit
        0.42
        upper Limit
        2.2
        value
        0.98
      8. group Id
        OG007
        lower Limit
        0.50
        upper Limit
        1.1
        value
        0.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        10
      8. group Id
        OG007
        value
        4
      units
      Participants
    title
    Cycle 1 Day 22
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      7
    units
    Participants
description
The median Tmax of oprozomib is presented following dosing on cycle 1 day 8 and cycle 1 day 22 for the IR and GR oprozomib formulations.
dispersion Type
Full Range
groups
  1. description
    In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
    id
    OG000
    title
    Oprozomib IR 150 mg/Day + Dexamethsone
  2. description
    In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
    id
    OG001
    title
    Oprozomib GR 150 mg/Day + Dexamethasone
  3. description
    In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG002
    title
    Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
  4. description
    In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG003
    title
    Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
  5. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG004
    title
    Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
  6. description
    In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG005
    title
    Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
  7. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG006
    title
    Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
  8. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG007
    title
    Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
param Type
MEDIAN
population Description
Participants in the PK analysis set with data available at each time point. The PK analysis set included participants for whom at least 1 PK parameter could be adequately estimated, excluding roll-over participants.
reporting Status
POSTED
time Frame
Cycle 1 days 8 and 22: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose. GR only: cycle 1 day 8: 8 hours post-dose
title
Time to Cmax (Tmax) of Oprozomib
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice