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NCT05397171 · OUTCOME

Percentage Change From Baseline in Circulating Growth Differentiation Factor 15 (GDF15) Serum Levels

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours · Source last updated 2024-10-01

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

Measure
MEAN
Unit
Percentage change from baseline in GDF15
Interval / dispersion
Standard Deviation
Time frame
0 hours post EOI of Cycle 1 Day 1, Day 1 (Pre-dose) of Cycles 2 and 3 (each cycle equals to 21 days) and 90-days post EOT of 90 days follow-up

What was measured

The pharmacodynamics (PD) activity of AZD8853 by assessment of candidate biomarkers in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy1 Part A. End of infusion= EOI; End of treatment= EOT

Analysis population: PD analysis set included all participants who received at least one dose of IP with at least one reportable concentration. Here, "number of participants analyzed" specifies all participants who were evaluated for this outcome measure and "n" (number analyzed in each raw) signifies the participants with available data that were analyzed for each timepoint for this outcome measure.

Groups in this outcome

AZD8853 300 mg

Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

AZD8853 1000 mg

Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

AZD8853 3000 mg

Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

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

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg3
AZD8853 1000 mg6
AZD8853 3000 mg6

Reported measurements

Cycle 1 Day 1: 0 hours post EOI

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg3
AZD8853 1000 mg4
AZD8853 3000 mg1
Values in Percentage change from baseline in GDF15 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg-97.78500.1917Not reportedNot reportedNot reported
AZD8853 1000 mg-99.26370.1161Not reportedNot reportedNot reported
AZD8853 3000 mg-99.7472NANot reportedNot reportedHere, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
Cycle 2 Day 1 (Pre-dose)

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg3
AZD8853 1000 mg6
AZD8853 3000 mg6
Values in Percentage change from baseline in GDF15 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg324.2284103.7778Not reportedNot reportedNot reported
AZD8853 1000 mg411.2175345.6173Not reportedNot reportedNot reported
AZD8853 3000 mg165.966882.9703Not reportedNot reportedNot reported
Cycle 3 Day 1 (Pre-dose)

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg1
AZD8853 1000 mg2
AZD8853 3000 mg3
Values in Percentage change from baseline in GDF15 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg636.8307NANot reportedNot reportedHere, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
AZD8853 1000 mg770.4598520.3336Not reportedNot reportedNot reported
AZD8853 3000 mg212.5270111.5861Not reportedNot reportedNot reported
90 Days Follow-Up: 90 days post EOT

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg1
AZD8853 1000 mg1
AZD8853 3000 mg1
Values in Percentage change from baseline in GDF15 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg2164.2547NANot reportedNot reportedHere, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
AZD8853 1000 mg1311.2845NANot reportedNot reportedHere, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
AZD8853 3000 mg2513.913NANot reportedNot reportedHere, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1917
        value
        -97.7850
      2. group Id
        OG001
        spread
        0.1161
        value
        -99.2637
      3. comment
        Here, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
        group Id
        OG002
        spread
        NA
        value
        -99.7472
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Cycle 1 Day 1: 0 hours post EOI
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        103.7778
        value
        324.2284
      2. group Id
        OG001
        spread
        345.6173
        value
        411.2175
      3. group Id
        OG002
        spread
        82.9703
        value
        165.9668
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    Cycle 2 Day 1 (Pre-dose)
  3. categories
    1. measurements
      1. comment
        Here, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
        group Id
        OG000
        spread
        NA
        value
        636.8307
      2. group Id
        OG001
        spread
        520.3336
        value
        770.4598
      3. group Id
        OG002
        spread
        111.5861
        value
        212.5270
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Cycle 3 Day 1 (Pre-dose)
  4. categories
    1. measurements
      1. comment
        Here, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
        group Id
        OG000
        spread
        NA
        value
        2164.2547
      2. comment
        Here, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
        group Id
        OG001
        spread
        NA
        value
        1311.2845
      3. comment
        Here, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
        group Id
        OG002
        spread
        NA
        value
        2513.913
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    90 Days Follow-Up: 90 days post EOT
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    units
    Participants
description
The pharmacodynamics (PD) activity of AZD8853 by assessment of candidate biomarkers in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy1 Part A. End of infusion= EOI; End of treatment= EOT
dispersion Type
Standard Deviation
groups
  1. description
    Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    OG000
    title
    AZD8853 300 mg
  2. description
    Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    OG001
    title
    AZD8853 1000 mg
  3. description
    Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    OG002
    title
    AZD8853 3000 mg
param Type
MEAN
population Description
PD analysis set included all participants who received at least one dose of IP with at least one reportable concentration. Here, "number of participants analyzed" specifies all participants who were evaluated for this outcome measure and "n" (number analyzed in each raw) signifies the participants with available data that were analyzed for each timepoint for this outcome measure.
reporting Status
POSTED
time Frame
0 hours post EOI of Cycle 1 Day 1, Day 1 (Pre-dose) of Cycles 2 and 3 (each cycle equals to 21 days) and 90-days post EOT of 90 days follow-up
title
Percentage Change From Baseline in Circulating Growth Differentiation Factor 15 (GDF15) Serum Levels
type
SECONDARY
unit Of Measure
Percentage change from baseline in GDF15

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Preserved source evidence · Not medical advice