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NCT05397171 · OUTCOME

Percentage Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Levels From Baseline

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 ctDNA
Interval / dispersion
Standard Deviation
Time frame
Baseline (pre-treatment), Day 8 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3, 4, 5, 7 (each cycle is equal to 21 days)

What was measured

Change in ctDNA is defined as the percentage change in ctDNA from baseline to each timepoint for the safety population. This outcome measure was assessed only for substudy 1 Part A.

Analysis population: Safety set included all participants who received any amount of IP. 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 8

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg3
AZD8853 1000 mg6
AZD8853 3000 mg6
Values in Percentage change from baseline in ctDNA · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg74.3700103.6200Not reportedNot reportedNot reported
AZD8853 1000 mg30.254698.8909Not reportedNot reportedNot reported
AZD8853 3000 mg10.779553.1457Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg3
AZD8853 1000 mg6
AZD8853 3000 mg6
Values in Percentage change from baseline in ctDNA · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg92.110583.4783Not reportedNot reportedNot reported
AZD8853 1000 mg32.143048.9060Not reportedNot reportedNot reported
AZD8853 3000 mg20.738678.4507Not reportedNot reportedNot reported
Cycle 2 Day 8

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg3
AZD8853 1000 mg6
AZD8853 3000 mg3
Values in Percentage change from baseline in ctDNA · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg101.000363.4941Not reportedNot reportedNot reported
AZD8853 1000 mg84.2143101.8080Not reportedNot reportedNot reported
AZD8853 3000 mg116.3071192.7165Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg3
AZD8853 1000 mg4
AZD8853 3000 mg1
Values in Percentage change from baseline in ctDNA · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg64.980722.7578Not reportedNot reportedNot reported
AZD8853 1000 mg131.5277161.3495Not reportedNot reportedNot reported
AZD8853 3000 mg26.9231NANot reportedNot reportedHere, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg1
AZD8853 1000 mg2
AZD8853 3000 mg1
Values in Percentage change from baseline in ctDNA · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg-8.3636NANot 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 mg50.290454.8320Not reportedNot reportedNot reported
AZD8853 3000 mg21.4744NANot reportedNot reportedHere, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg1
AZD8853 1000 mg1
AZD8853 3000 mg0
Values in Percentage change from baseline in ctDNA · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg64NANot 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 mg50.4363NANot reportedNot reportedHere, 'NA' indicates that standard deviation was not calculated due to the presence of only one participant at this specific time point.
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg1
AZD8853 1000 mg0
AZD8853 3000 mg0
Values in Percentage change from baseline in ctDNA · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg67.8182NANot 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
        103.6200
        value
        74.3700
      2. group Id
        OG001
        spread
        98.8909
        value
        30.2546
      3. group Id
        OG002
        spread
        53.1457
        value
        10.7795
    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 1 Day 8
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        83.4783
        value
        92.1105
      2. group Id
        OG001
        spread
        48.9060
        value
        32.1430
      3. group Id
        OG002
        spread
        78.4507
        value
        20.7386
    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
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        63.4941
        value
        101.0003
      2. group Id
        OG001
        spread
        101.8080
        value
        84.2143
      3. group Id
        OG002
        spread
        192.7165
        value
        116.3071
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Cycle 2 Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.7578
        value
        64.9807
      2. group Id
        OG001
        spread
        161.3495
        value
        131.5277
      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
        26.9231
    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 3 Day 1
  5. 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
        -8.3636
      2. group Id
        OG001
        spread
        54.8320
        value
        50.2904
      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
        21.4744
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Cycle 4 Day 1
  6. 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
        64
      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
        50.4363
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Cycle 5 Day 1
  7. 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
        67.8182
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Cycle 7 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Change in ctDNA is defined as the percentage change in ctDNA from baseline to each timepoint for the safety population. This outcome measure was assessed only for substudy 1 Part A.
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
Safety set included all participants who received any amount of IP. 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
Baseline (pre-treatment), Day 8 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3, 4, 5, 7 (each cycle is equal to 21 days)
title
Percentage Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Levels From Baseline
type
SECONDARY
unit Of Measure
Percentage change from baseline in ctDNA

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

Preserved source evidence · Not medical advice