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NCT05140382 · OUTCOME

Half-life (t1/2) of AZD4573

AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL · Source last updated 2024-08-28

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

Measure
MEDIAN
Unit
Hour
Interval / dispersion
Full Range
Time frame
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.

What was measured

The plasma PK of AZD4573 when administered in participants was assessed.

Analysis population: PK set included all participants who received any amount of study intervention with at least 1 reportable concentration. Here, 'n" (number analyzed in each row) signifies the participants with available data that were analyzed for each timepoint of this outcome measure.

Groups in this outcome

Cohort 1 Non-NK PTCL

Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.

Cohort 2 NK PTCL

Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.

Cohort 3 cHL

Participants with cHL received 12 mg dose of AZD4573 once weekly 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
Cohort 1 Non-NK PTCL18
Cohort 2 NK PTCL1
Cohort 3 cHL12

Reported measurements

Cycle 1 week 1 day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Non-NK PTCL18
Cohort 2 NK PTCL0
Cohort 3 cHL9
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL5.772Not reported1.6711.6Not reported
Cohort 3 cHL5.858Not reported3.687.90Not reported
Cycle 1 week 2 day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Non-NK PTCL17
Cohort 2 NK PTCL1
Cohort 3 cHL9
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL5.448Not reported4.1011.3Not reported
Cohort 2 NK PTCLNANot reported6.806.80Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
Cohort 3 cHL5.250Not reported4.119.71Not reported
Cycle 1 week 3 day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Non-NK PTCL18
Cohort 2 NK PTCL1
Cohort 3 cHL12
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL5.435Not reported1.1510.5Not reported
Cohort 2 NK PTCLNANot reported5.095.09Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
Cohort 3 cHL5.499Not reported3.9323.5Not reported
Cycle 2 day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Non-NK PTCL14
Cohort 2 NK PTCL0
Cohort 3 cHL7
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL6.669Not reported3.5016.0Not reported
Cohort 3 cHL4.323Not reported3.5614.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.67
        upper Limit
        11.6
        value
        5.772
      2. group Id
        OG002
        lower Limit
        3.68
        upper Limit
        7.90
        value
        5.858
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        9
      units
      Participants
    title
    Cycle 1 week 1 day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.10
        upper Limit
        11.3
        value
        5.448
      2. comment
        Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
        group Id
        OG001
        lower Limit
        6.80
        upper Limit
        6.80
        value
        NA
      3. group Id
        OG002
        lower Limit
        4.11
        upper Limit
        9.71
        value
        5.250
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        9
      units
      Participants
    title
    Cycle 1 week 2 day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.15
        upper Limit
        10.5
        value
        5.435
      2. comment
        Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
        group Id
        OG001
        lower Limit
        5.09
        upper Limit
        5.09
        value
        NA
      3. group Id
        OG002
        lower Limit
        3.93
        upper Limit
        23.5
        value
        5.499
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        12
      units
      Participants
    title
    Cycle 1 week 3 day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.50
        upper Limit
        16.0
        value
        6.669
      2. group Id
        OG002
        lower Limit
        3.56
        upper Limit
        14.7
        value
        4.323
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        7
      units
      Participants
    title
    Cycle 2 day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      12
    units
    Participants
description
The plasma PK of AZD4573 when administered in participants was assessed.
dispersion Type
Full Range
groups
  1. description
    Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
    id
    OG000
    title
    Cohort 1 Non-NK PTCL
  2. description
    Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
    id
    OG001
    title
    Cohort 2 NK PTCL
  3. description
    Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
    id
    OG002
    title
    Cohort 3 cHL
param Type
MEDIAN
population Description
PK set included all participants who received any amount of study intervention with at least 1 reportable concentration. Here, 'n" (number analyzed in each row) signifies the participants with available data that were analyzed for each timepoint of this outcome measure.
reporting Status
POSTED
time Frame
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
title
Half-life (t1/2) of AZD4573
type
SECONDARY
unit Of Measure
Hour

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

Preserved source evidence · Not medical advice