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NCT04075721 · OUTCOME

Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Time from first treatment up to 30 days after end of study intervention (assessed up to 24.3 weeks)

What was measured

ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. ECOG performance status was reported in terms of number of participants with shifts in score from baseline value vs worst post-baseline value (that is \[i.e.\] highest score).

Analysis population: Safety analysis set included all participants who were administered any dose of the study medication.

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 QD2
M3258 10 mg Twice Per Week4
M3258 20 mg Twice Per Week4

Reported measurements

Baseline score 0, worst post-baseline score 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 0, worst post-baseline score 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD1Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week2Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week1Not reportedNot reportedNot reportedNot reported
Baseline score 0, worst post-baseline score 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 0, worst post-baseline score 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week1Not reportedNot reportedNot reportedNot reported
Baseline score 0, worst post-baseline score 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 0, worst post-baseline score 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 1, worst post-baseline score 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD1Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week1Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 1, worst post-baseline score 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week1Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 1, worst post-baseline score 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week1Not reportedNot reportedNot reportedNot reported
Baseline score 1, worst post-baseline score 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week1Not reportedNot reportedNot reportedNot reported
Baseline score 1, worst post-baseline score 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 1, worst post-baseline score 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 2, worst post-baseline score 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 2, worst post-baseline score 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 2, worst post-baseline score 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 2, worst post-baseline score 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 2, worst post-baseline score 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 2, worst post-baseline score 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 3, worst post-baseline score 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 3, worst post-baseline score 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 3, worst post-baseline score 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 3, worst post-baseline score 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 3, worst post-baseline score 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 3, worst post-baseline score 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 4, worst post-baseline score 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 4, worst post-baseline score 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 4, worst post-baseline score 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 4, worst post-baseline score 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 4, worst post-baseline score 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 4, worst post-baseline score 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 5, worst post-baseline score 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 5, worst post-baseline score 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 5, worst post-baseline score 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 5, worst post-baseline score 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 5, worst post-baseline score 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Baseline score 5, worst post-baseline score 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 0, worst post-baseline score 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
    title
    Baseline score 0, worst post-baseline score 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 0, worst post-baseline score 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Baseline score 0, worst post-baseline score 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 0, worst post-baseline score 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 0, worst post-baseline score 5
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Baseline score 1, worst post-baseline score 0
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Baseline score 1, worst post-baseline score 1
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Baseline score 1, worst post-baseline score 2
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Baseline score 1, worst post-baseline score 3
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 1, worst post-baseline score 4
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Baseline score 1, worst post-baseline score 5
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    units
    Participants
description
ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. ECOG performance status was reported in terms of number of participants with shifts in score from baseline value vs worst post-baseline value (that is \[i.e.\] highest score).
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
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who were administered any dose of the study medication.
reporting Status
POSTED
time Frame
Time from first treatment up to 30 days after end of study intervention (assessed up to 24.3 weeks)
title
Part A: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice