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NCT05140382 · OUTCOME

Volume of Distribution at Steady State (Vss)

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
GEOMETRIC_MEAN
Unit
Liter
Interval / dispersion
Geometric Coefficient of Variation
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 cHL11

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 Liter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL35.8051.1Not reportedNot reportedNot reported
Cohort 3 cHL24.2054.3Not reportedNot reportedNot 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 Liter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL39.2551.3Not reportedNot reportedNot reported
Cohort 2 NK PTCLNANANot reportedNot reportedHere, "NA" indicates that data could not be evaluated due to smaller number of participants.
Cohort 3 cHL33.2036.9Not reportedNot reportedNot reported
Cycle 1 week 3 day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Non-NK PTCL18
Cohort 2 NK PTCL1
Cohort 3 cHL11
Values in Liter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL50.3227.8Not reportedNot reportedNot reported
Cohort 2 NK PTCLNANANot reportedNot reportedHere, "NA" indicates that data could not be evaluated due to smaller number of participants.
Cohort 3 cHL37.9966.3Not reportedNot reportedNot reported
Cycle 2 day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Non-NK PTCL14
Cohort 2 NK PTCL0
Cohort 3 cHL7
Values in Liter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL55.9336.8Not reportedNot reportedNot reported
Cohort 3 cHL37.2954.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.1
        value
        35.80
      2. group Id
        OG002
        spread
        54.3
        value
        24.20
    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
        spread
        51.3
        value
        39.25
      2. comment
        Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. group Id
        OG002
        spread
        36.9
        value
        33.20
    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
        spread
        27.8
        value
        50.32
      2. comment
        Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. group Id
        OG002
        spread
        66.3
        value
        37.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Cycle 1 week 3 day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.8
        value
        55.93
      2. group Id
        OG002
        spread
        54.6
        value
        37.29
    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
      11
    units
    Participants
description
The plasma PK of AZD4573 when administered in participants was assessed.
dispersion Type
Geometric Coefficient of Variation
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
GEOMETRIC_MEAN
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
Volume of Distribution at Steady State (Vss)
type
SECONDARY
unit Of Measure
Liter

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Preserved source evidence · Not medical advice