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NCT05038800 · OUTCOME

Area Under the Plasma Concentration-Time Curve From Time Zero to 21 Days (AUC0-21) of MK-0482

A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002) · Source last updated 2025-05-21

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

Measure
GEOMETRIC_MEAN
Unit
day*ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.

What was measured

AUC0-21 was defined as the area under the plasma concentration-time curve from time zero to 21 days. Blood samples were collected pre-dose and post-dose at designated timepoints to determine AUC0-21 of MK-0482.

Analysis population: All allocated participants who received at least 1 dose of study intervention, were compliant with the study procedures, and had available data from at least 1 treatment dose were analyzed.

Groups in this outcome

MK-0482 7.5 mg Q3W

Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for up to 35 cycles (approximately 24 months).

MK-0482 25 mg Q3W

Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

MK-0482 75 mg Q3W

Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

MK-0482 225 mg Q3W

Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

MK-0482 750 mg Q3W

Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

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

Analysis denominator · Participants

GroupSource count
MK-0482 7.5 mg Q3W1
MK-0482 25 mg Q3W1
MK-0482 75 mg Q3W5
MK-0482 225 mg Q3W3
MK-0482 750 mg Q3W2

Reported measurements

Source class 1
Values in day*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
MK-0482 7.5 mg Q3W3110NANot reportedNot reportedNA = Geometric coefficient of variation values were not reported when N \< 2.
MK-0482 25 mg Q3W17200NANot reportedNot reportedNA = Geometric coefficient of variation values were not reported when N \< 2.
MK-0482 75 mg Q3W10500064.5Not reportedNot reportedNot reported
MK-0482 225 mg Q3W52100022.9Not reportedNot reportedNot reported
MK-0482 750 mg Q3W88500012.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA = Geometric coefficient of variation values were not reported when N \< 2.
        group Id
        OG000
        spread
        NA
        value
        3110
      2. comment
        NA = Geometric coefficient of variation values were not reported when N \< 2.
        group Id
        OG001
        spread
        NA
        value
        17200
      3. group Id
        OG002
        spread
        64.5
        value
        105000
      4. group Id
        OG003
        spread
        22.9
        value
        521000
      5. group Id
        OG004
        spread
        12.4
        value
        885000
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      2
    units
    Participants
description
AUC0-21 was defined as the area under the plasma concentration-time curve from time zero to 21 days. Blood samples were collected pre-dose and post-dose at designated timepoints to determine AUC0-21 of MK-0482.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for up to 35 cycles (approximately 24 months).
    id
    OG000
    title
    MK-0482 7.5 mg Q3W
  2. description
    Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG001
    title
    MK-0482 25 mg Q3W
  3. description
    Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG002
    title
    MK-0482 75 mg Q3W
  4. description
    Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG003
    title
    MK-0482 225 mg Q3W
  5. description
    Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG004
    title
    MK-0482 750 mg Q3W
param Type
GEOMETRIC_MEAN
population Description
All allocated participants who received at least 1 dose of study intervention, were compliant with the study procedures, and had available data from at least 1 treatment dose were analyzed.
reporting Status
POSTED
time Frame
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.
title
Area Under the Plasma Concentration-Time Curve From Time Zero to 21 Days (AUC0-21) of MK-0482
type
SECONDARY
unit Of Measure
day*ng/mL

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Preserved source evidence · Not medical advice