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NCT05209152 · OUTCOME

Area Under the Plasma Concentration Time Curve From 0 to 168 Hours (AUC168hr) of AMG 176

AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia · Source last updated 2025-07-14

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

Measure
MEAN
Unit
hour*ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1: pre-dose, EOI, 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4

What was measured

AMG 176 plasma concentrations with values below the limit of quantification were set to zero. PK parameters were determined from the time concentration profile using noncompartmental analysis.

Analysis population: The PK analysis set included all participants who received at least 1 dose of AMG 176 and had at least 1 PK sample collected. Participants with data available at each time point are included.

Groups in this outcome

Part 1A Dose Exploration: AMG 176 Dose Level 1

Participants received IV AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity.

Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2

Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Part 1A Dose Exploration: AMG 176 Dose Level 14
Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 23

Reported measurements

Cycle 1 day 1

Analysis denominator · Participants

GroupSource count
Part 1A Dose Exploration: AMG 176 Dose Level 14
Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 23
Values in hour*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1A Dose Exploration: AMG 176 Dose Level 1198000148000Not reportedNot reportedNot reported
Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 27590032000Not reportedNot reportedNot reported
Cycle 1 day 8

Analysis denominator · Participants

GroupSource count
Part 1A Dose Exploration: AMG 176 Dose Level 13
Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 23
Values in hour*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1A Dose Exploration: AMG 176 Dose Level 1167000146000Not reportedNot reportedNot reported
Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 217900085600Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        148000
        value
        198000
      2. group Id
        OG001
        spread
        32000
        value
        75900
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 1 day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        146000
        value
        167000
      2. group Id
        OG001
        spread
        85600
        value
        179000
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 1 day 8
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    units
    Participants
description
AMG 176 plasma concentrations with values below the limit of quantification were set to zero. PK parameters were determined from the time concentration profile using noncompartmental analysis.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received IV AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Part 1A Dose Exploration: AMG 176 Dose Level 1
  2. description
    Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2
param Type
MEAN
population Description
The PK analysis set included all participants who received at least 1 dose of AMG 176 and had at least 1 PK sample collected. Participants with data available at each time point are included.
reporting Status
POSTED
time Frame
Cycle 1: pre-dose, EOI, 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4
title
Area Under the Plasma Concentration Time Curve From 0 to 168 Hours (AUC168hr) of AMG 176
type
SECONDARY
unit Of Measure
hour*ng/mL

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

Preserved source evidence · Not medical advice