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NCT04075721 · OUTCOME

Part A: Multiple Dose: Area Under Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) of M3258

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Cycle 1 Day 8 or Cycle 1 Day 15: Pre-dose 1, 2, 3, 4, 5, 6, and 8 hours post-dose (each Cycle is of 28 days)

What was measured

Area under the plasma concentration versus time curve from time zero to 24 hours post dosing for M3258.

Analysis population: The most participants who had evaluable PK, samples at 24 hour (Day 2) were collected. Therefore, the AUC0-t and AUC0-24 would not differ and AUC0-24 at single dose was not reported. It was also planned to carry the trough value at steady state for QD dosing forward and impute it as trough value at 24 hours. Due to the change from the QD to twice per week dosing this did not apply anymore and AUC0-24 at steady state was not calculated.

Groups in this outcome

M3258 10 mg Twice Per Week

Participants received M3258 at a dose of 10 mg orally, twice per week 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.

M3258 10 mg QD

Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) 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 Twice Per Week0
M3258 20 mg Twice Per Week0
M3258 10 mg QD0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Area under the plasma concentration versus time curve from time zero to 24 hours post dosing for M3258.
groups
  1. description
    Participants received M3258 at a dose of 10 mg orally, twice per week until disease progression.
    id
    OG000
    title
    M3258 10 mg Twice Per Week
  2. description
    Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.
    id
    OG001
    title
    M3258 20 mg Twice Per Week
  3. description
    Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.
    id
    OG002
    title
    M3258 10 mg QD
population Description
The most participants who had evaluable PK, samples at 24 hour (Day 2) were collected. Therefore, the AUC0-t and AUC0-24 would not differ and AUC0-24 at single dose was not reported. It was also planned to carry the trough value at steady state for QD dosing forward and impute it as trough value at 24 hours. Due to the change from the QD to twice per week dosing this did not apply anymore and AUC0-24 at steady state was not calculated.
reporting Status
POSTED
time Frame
Cycle 1 Day 8 or Cycle 1 Day 15: Pre-dose 1, 2, 3, 4, 5, 6, and 8 hours post-dose (each Cycle is of 28 days)
title
Part A: Multiple Dose: Area Under Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) of M3258
type
SECONDARY

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

Preserved source evidence · Not medical advice