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NCT05140382 · OUTCOME

Maximum Observed Plasma (Peak) Drug Concentration (Cmax)

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
Nanogram per milliliter (ng/mL)
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: Pharmacokinetic (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 PTCL31
Cohort 2 NK PTCL2
Cohort 3 cHL19

Reported measurements

Cycle 1 week 1 day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Non-NK PTCL31
Cohort 2 NK PTCL2
Cohort 3 cHL19
Values in Nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL159.953.2Not 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 cHL201.882.1Not reportedNot reportedNot reported
Cycle 1 week 2 day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Non-NK PTCL25
Cohort 2 NK PTCL1
Cohort 3 cHL15
Values in Nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL312.484.5Not 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 cHL278.273.8Not reportedNot reportedNot reported
Cycle 1 week 3 day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Non-NK PTCL25
Cohort 2 NK PTCL1
Cohort 3 cHL16
Values in Nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL265.554.1Not 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 cHL376.389.9Not reportedNot reportedNot reported
Cycle 2 day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Non-NK PTCL16
Cohort 2 NK PTCL0
Cohort 3 cHL14
Values in Nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Non-NK PTCL308.665.9Not reportedNot reportedNot reported
Cohort 3 cHL381.882.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        53.2
        value
        159.9
      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
        82.1
        value
        201.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        19
      units
      Participants
    title
    Cycle 1 week 1 day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        84.5
        value
        312.4
      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
        73.8
        value
        278.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        15
      units
      Participants
    title
    Cycle 1 week 2 day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.1
        value
        265.5
      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
        89.9
        value
        376.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        16
      units
      Participants
    title
    Cycle 1 week 3 day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.9
        value
        308.6
      2. group Id
        OG002
        spread
        82.5
        value
        381.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        14
      units
      Participants
    title
    Cycle 2 day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      19
    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
Pharmacokinetic (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
Maximum Observed Plasma (Peak) Drug Concentration (Cmax)
type
SECONDARY
unit Of Measure
Nanogram per milliliter (ng/mL)

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Preserved source evidence · Not medical advice