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NCT04075721 · OUTCOME

Part A: Multiple Dose: Ratio to Baseline in Large Multifunctional Protease 7 (LMP7) Activity at Cycle 1 Day 8 (or Day 15)

First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone · Source last updated 2023-03-24

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

Measure
MEAN
Unit
ratio
Interval / dispersion
Full Range
Time frame
Cycle 1 Day 1 pre-dose (Baseline), Pre-dose, 2 and 6 hours post-dose on Cycle 1 Day 8 (or Day 15) (each Cycle is of 28 days)

What was measured

Ratio to baseline was calculated dividing post-baseline measurements by the baseline measurement.

Analysis population: The Pd population included all participants who received at least one dose of study intervention, had no clinically important protocol deviations or important events affecting Pd, and provide at least one measurable Pd endpoint post-dose. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for specified timepoints.

Groups in this outcome

M3258 10 mg QD

Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.

M3258 10 mg Twice Per Week

Participants received M3258 at a dose of 10 mg orally, twice per week on Day 1 and Day 4 until disease progression.

M3258 20 mg Twice Per Week

Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.

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

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD1
M3258 10 mg Twice Per Week2
M3258 20 mg Twice Per Week2

Reported measurements

Cycle 1 Day 8 (or Day 15): Pre-dose

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD1
M3258 10 mg Twice Per Week2
M3258 20 mg Twice Per Week1
Values in ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0.26Not reported0.260.26Not reported
M3258 10 mg Twice Per Week0.364Not reported0.360.37Not reported
M3258 20 mg Twice Per Week0.31Not reported0.310.31Not reported
Cycle 1 Day 8 (or Day 15): 2 hours post-dose

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD1
M3258 10 mg Twice Per Week2
M3258 20 mg Twice Per Week2
Values in ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0.25Not reported0.250.25Not reported
M3258 10 mg Twice Per Week0.202Not reported0.170.24Not reported
M3258 20 mg Twice Per Week0.299Not reported0.160.44Not reported
Cycle 1 Day 8 (or Day 15): 6 hours post-dose

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD0
M3258 10 mg Twice Per Week2
M3258 20 mg Twice Per Week1
Values in ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg Twice Per Week0.178Not reported0.170.19Not reported
M3258 20 mg Twice Per Week0.22Not reported0.220.22Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.26
        upper Limit
        0.26
        value
        0.26
      2. group Id
        OG001
        lower Limit
        0.36
        upper Limit
        0.37
        value
        0.364
      3. group Id
        OG002
        lower Limit
        0.31
        upper Limit
        0.31
        value
        0.31
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Cycle 1 Day 8 (or Day 15): Pre-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.25
        upper Limit
        0.25
        value
        0.25
      2. group Id
        OG001
        lower Limit
        0.17
        upper Limit
        0.24
        value
        0.202
      3. group Id
        OG002
        lower Limit
        0.16
        upper Limit
        0.44
        value
        0.299
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Cycle 1 Day 8 (or Day 15): 2 hours post-dose
  3. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0.17
        upper Limit
        0.19
        value
        0.178
      2. group Id
        OG002
        lower Limit
        0.22
        upper Limit
        0.22
        value
        0.22
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Cycle 1 Day 8 (or Day 15): 6 hours post-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    units
    Participants
description
Ratio to baseline was calculated dividing post-baseline measurements by the baseline measurement.
dispersion Type
Full Range
groups
  1. description
    Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.
    id
    OG000
    title
    M3258 10 mg QD
  2. description
    Participants received M3258 at a dose of 10 mg orally, twice per week on Day 1 and Day 4 until disease progression.
    id
    OG001
    title
    M3258 10 mg Twice Per Week
  3. description
    Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.
    id
    OG002
    title
    M3258 20 mg Twice Per Week
param Type
MEAN
population Description
The Pd population included all participants who received at least one dose of study intervention, had no clinically important protocol deviations or important events affecting Pd, and provide at least one measurable Pd endpoint post-dose. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for specified timepoints.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 pre-dose (Baseline), Pre-dose, 2 and 6 hours post-dose on Cycle 1 Day 8 (or Day 15) (each Cycle is of 28 days)
title
Part A: Multiple Dose: Ratio to Baseline in Large Multifunctional Protease 7 (LMP7) Activity at Cycle 1 Day 8 (or Day 15)
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice