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    Clinical Trial Results:
    A Modular Phase II, Open-label, Multicentre Study to Assess AZD4573 Efficacy and Safety as Monotherapy or in Combination With Anti-cancer Agents in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma or Classical Hodgkin Lymphoma

    Summary
    EudraCT number
    		 2021-002570-54
    Trial protocol
    		 FR   IT  
    Global end of trial date
    16 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2025
    First version publication date
    20 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D8231C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05140382
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    AstraZeneca AB, 151 85, Södertälje, Sweden, 15185
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Aug 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of AZD4573 monotherapy by evaluation of objective response rate.
    Protection of trial subjects
    The study was conducted in accordance with the protocol, with the consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines for Health-related Research Involving Humans and with the applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, as well as for any applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 8
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 13
    Worldwide total number of subjects
    52
    EEA total number of subjects
    15
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    37
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted from 15 December 2021 (first subject visit) to 16 February 2024 (last subject last visit). The study was conducted at 27 sites in 7 countries worldwide (Australia, France, Italy, South Korea, Taiwan, United Kingdom and United States).

    Pre-assignment
    Screening details
    		 Subjects who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open-label study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1 Non NK PTCL
    Arm description
    		 Subjects with non-natural killer peripheral T-cell lymphoma (non-NK PTCL) received 12 mg dose of AZD4573 once weekly until disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD4573
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received 12 mg dose of AZD4573 once weekly until disease progression.

    Arm title
    		 Cohort 2 NK PTCL
    Arm description
    		 Subjects with natural killer T-cell lymphoma (NK PTCL) received 12 mg dose of AZD4573 once weekly until disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD4573
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received 12 mg dose of AZD4573 once weekly until disease progression.

    Arm title
    		 Cohort 3 cHL
    Arm description
    		 Subjects with classical Hodgkins lymphoma (cHL) received 12 mg dose of AZD4573 once weekly until disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD4573
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received 12 mg dose of AZD4573 once weekly until disease progression.

    Number of subjects in period 1
    		Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Started
    31
    2
    19
    Completed
    0
    0
    0
    Not completed
    31
    2
    19
         Adverse event, serious fatal
    3
    -
    -
         Consent withdrawn by subject
    1
    -
    4
         Unknown at data cut-off
    -
    -
    1
         Investigator decision
    1
    -
    -
         Unspecified
    4
    -
    1
         Subjective disease progression
    2
    1
    -
         Withdrawal of consent
    -
    -
    1
         Progressive disease
    20
    1
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1 Non NK PTCL
    Reporting group description
    		 Subjects with non-natural killer peripheral T-cell lymphoma (non-NK PTCL) received 12 mg dose of AZD4573 once weekly until disease progression.

    Reporting group title
    Cohort 2 NK PTCL
    Reporting group description
    		 Subjects with natural killer T-cell lymphoma (NK PTCL) received 12 mg dose of AZD4573 once weekly until disease progression.

    Reporting group title
    Cohort 3 cHL
    Reporting group description
    		 Subjects with classical Hodgkins lymphoma (cHL) received 12 mg dose of AZD4573 once weekly until disease progression.

    Reporting group values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL Total
    Number of subjects
    		 31 2 19 52
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 19 1 17 37
        From 65-84 years
    		 12 1 2 15
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 60.1 ( 12.2 ) 61.0 ( 8.5 ) 46.5 ( 14.7 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 13 0 10 23
        Male
    		 18 2 9 29

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1 Non NK PTCL
    Reporting group description
    		 Subjects with non-natural killer peripheral T-cell lymphoma (non-NK PTCL) received 12 mg dose of AZD4573 once weekly until disease progression.

    Reporting group title
    Cohort 2 NK PTCL
    Reporting group description
    		 Subjects with natural killer T-cell lymphoma (NK PTCL) received 12 mg dose of AZD4573 once weekly until disease progression.

    Reporting group title
    Cohort 3 cHL
    Reporting group description
    		 Subjects with classical Hodgkins lymphoma (cHL) received 12 mg dose of AZD4573 once weekly until disease progression.

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR) [1]
    End point description
    Objective response rate is defined as the proportion of subjects who have a tumour response of complete response [CR] or partial response [PR] according to the Lugano (2014) response criteria for malignant lymphoma. Response evaluable set included all dosed subjects who had measurable disease at baseline.
    End point type
    Primary
    End point timeframe
    From Screening (Day -30 to Day-1) until disease progression or survival until end of study (26 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed.
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    31
    2
    19
    Units: Percentage of subjects
        number (confidence interval 95%)
    22.6 (9.59 to 41.10)
    0 (0 to 84.19)
    21.1 (6.05 to 45.57)
    No statistical analyses for this end point

    Secondary: Complete response (CR) rate

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    End point title
    		 Complete response (CR) rate
    End point description
    Complete response rate is defined as proportion of subjects who have a complete response according to the Lugano (2014) response criteria. Response evaluable set included all dosed subjects who had measurable disease at baseline.
    End point type
    Secondary
    End point timeframe
    From Screening (Day -30 to Day-1) until disease progression or survival until end of study (26 months).
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    31
    2
    19
    Units: Percentage of subjects
        number (not applicable)
    19.4
    0
    15.8
    No statistical analyses for this end point

    Secondary: Duration of response (DoR)

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    End point title
    		 Duration of response (DoR)
    End point description
    Duration of response is defined as the time from the first objective response to the time of documented disease progression or death due to any cause, whichever occurs first. The arbitrary value 99999 in cohort 1 and cohort 3 represent that data were not calculable due to insufficient number of subjects with the event of interest (less than 50%) occurred in the study. Response evaluable set included all dosed subjects who had measurable disease at baseline.
    End point type
    Secondary
    End point timeframe
    From Screening (Day -30 to Day-1) until disease progression or survival until end of study (26 months).
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    7
    0 [2]
    4
    Units: Months
        median (confidence interval 95%)
    99999 (1.8 to 99999)
    ( to )
    5.2 (1.9 to 99999)
    Notes
    [2] - Number of subjects analysed were 0 due to insufficient number of events of interest.
    No statistical analyses for this end point

    Secondary: Progression-free survival (PFS)

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    End point title
    		 Progression-free survival (PFS)
    End point description
    Progression-free survival is defined as the time from the date of first dose to documented disease progression, or death from any cause, whichever occurs first. The arbitrary value 99999 represents that data were not calculable due to low number of subjects. Full analysis set included all subjects who received any amount of any study intervention.
    End point type
    Secondary
    End point timeframe
    From Screening (Day -30 to Day-1) until disease progression or survival until end of study (26 months).
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    31
    2
    19
    Units: Months
        median (confidence interval 95%)
    1.8 (1.51 to 2.17)
    0.7 (0.66 to 99999)
    1.9 (1.64 to 4.11)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Overall survival is defined as the time from the date of first dose to death from any cause. The arbitrary value 99999 in cohort 2 represents that data were not calculable due to low number of subjects and in cohort 3 represents that data were not calculable due to less number of events of interest (less than 50%). Full analysis set included all subjects who received any amount of any study intervention.
    End point type
    Secondary
    End point timeframe
    From Screening (Day -30 to Day-1) until disease progression or survival until end of study (26 months).
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    31
    2
    19
    Units: Months
        median (confidence interval 95%)
    8.6 (2.33 to 10.18)
    99999 (0.66 to 99999)
    99999 (10.05 to 99999)
    No statistical analyses for this end point

    Secondary: Number of subjects with Adverse events (AE) and Serious AEs (SAE)

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    End point title
    		 Number of subjects with Adverse events (AE) and Serious AEs (SAE)
    End point description
    The safety and tolerability of AZD4573 was assessed. Adverse Event - AE Common Terminology Criteria for Adverse Events - CTCAE IMP - Investigational Medicinal Product Serious Adverse Event - SAE CTCAE grade 3 ≥ AE = Any AE of CTCAE grade 3 or higher Safety set included all subjects who received at least 1 dose of any study intervention.
    End point type
    Secondary
    End point timeframe
    From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    31
    2
    19
    Units: Subjects
        Any AE
    31
    2
    18
        IMP-related AEs
    31
    2
    16
        CTCAE grade 3 ≥ AEs
    29
    2
    15
        CTCAE grade 3 ≥ Treatment-related AEs
    27
    2
    13
        Any AE with death outcome
    2
    1
    0
        IMP-related AE with death outcome
    2
    0
    0
        SAE (including death outcome)
    21
    2
    11
        IMP-related SAE (including death outcome)
    16
    1
    8
    No statistical analyses for this end point

    Secondary: Maximum observed plasma (peak) drug concentration (Cmax)

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    End point title
    		 Maximum observed plasma (peak) drug concentration (Cmax)
    End point description
    The plasma PK of AZD4573 when administered in subjects was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint in each cohort. The arbitrary value 99999 in cycle 1 week 1, cycle 1 week 2, cycle 1 week 3 represents that data were not calculable due to low number of subjects and in cycle 2 represents that data were not available as no subjects were analysed. Pharmacokinetic (PK) set included all subjects who received any amount of study intervention with at least 1 reportable concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    31
    2
    19
    Units: Nanogram per milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1 week 1 day 1 (n: 31, 2, 19)
    159.9 ( 53.2 )
    99999 ( 99999 )
    201.8 ( 82.1 )
        Cycle 1 week 2 day 1 (n: 25, 1, 15)
    312.4 ( 84.5 )
    99999 ( 99999 )
    278.2 ( 73.8 )
        Cycle 1 week 3 day 1 (n: 25, 1, 16)
    265.5 ( 54.1 )
    99999 ( 99999 )
    376.3 ( 89.9 )
        Cycle 2 day 1 (n: 16, 0, 14)
    308.6 ( 65.9 )
    99999 ( 99999 )
    381.8 ( 82.5 )
    No statistical analyses for this end point

    Secondary: Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast)

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    End point title
    		 Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast)
    End point description
    The plasma PK of AZD4573 when administered in subjects was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint in each cohort. The arbitrary value 99999 in cycle 1 week 1, cycle 1 week 2, cycle 1 week 3 represents that data were not calculable due to low number of subjects and in cycle 2 represents that data were not available as no subjects were analysed. PK set included all subjects who received any amount of study intervention with at least 1 reportable concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    31
    2
    19
    Units: hours (h)*ng/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1 week 1 day 1 (n: 31, 2, 19)
    913.3 ( 95.0 )
    99999 ( 99999 )
    1039 ( 113.5 )
        Cycle 1 week 2 day 1 (n: 25, 1, 15)
    1695 ( 102.3 )
    99999 ( 99999 )
    1646 ( 86.7 )
        Cycle 1 week 3 day 1 (n: 25, 1, 16)
    1651 ( 76.5 )
    99999 ( 99999 )
    2228 ( 75.0 )
        Cycle 2 day 1 (n: 16, 0, 14)
    1933 ( 81.2 )
    99999 ( 99999 )
    2083 ( 115.9 )
    No statistical analyses for this end point

    Secondary: Area under plasma concentration time curve from zero to infinity (AUC0-inf) of AZD4573

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    End point title
    		 Area under plasma concentration time curve from zero to infinity (AUC0-inf) of AZD4573
    End point description
    The plasma PK of AZD4573 when administered in subjects was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint in each cohort. The arbitrary value 99999 in cycle 1 week 2 and cycle 1 week 3 represents that data were not calculable due to low number of subjects and in cycle 1 week 1 and cycle 2 represents that data were not available as no subjects were analysed. PK set included all subjects who received any amount of study intervention with at least 1 reportable concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    18
    1
    12
    Units: h*ng/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1 week 1 day 1 (n: 18, 0, 9)
    1294 ( 82.9 )
    99999 ( 99999 )
    1872 ( 59.3 )
        Cycle 1 week 2 day 1 (n: 17, 1, 9)
    1711 ( 86.8 )
    99999 ( 99999 )
    1984 ( 62.9 )
        Cycle 1 week 3 day 1 (n: 18, 1, 12)
    1490 ( 71.5 )
    99999 ( 99999 )
    2643 ( 88.2 )
        Cycle 2 day 1 (n: 14, 0, 7)
    1885 ( 72.9 )
    99999 ( 99999 )
    1899 ( 89.0 )
    No statistical analyses for this end point

    Secondary: Time to reach peak observed concentration following drug administration (tmax)

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    End point title
    		 Time to reach peak observed concentration following drug administration (tmax)
    End point description
    The plasma PK of AZD4573 when administered in subjects was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint in each cohort. The arbitrary value 99999 represents that data were not available as no subjects were analysed. The median values for cycle 1 week 1, cycle 1 week 2 and cycle 1 week 3 in cohort 2 were not calculable due to low number of subjects. PK set included all subjects who received any amount of study intervention with at least 1 reportable concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    31
    2
    19
    Units: Hour
    median (full range (min-max))
        Cycle 1 week 1 day 1 (n: 31, 2, 19)
    2.000 (0.97 to 6.00)
    2.15 (1.90 to 2.15)
    2.083 (1.00 to 23.00)
        Cycle 1 week 2 day 1 (n: 25, 1, 15)
    2.083 (1.87 to 6.08)
    2.15 (2.15 to 2.15)
    2.083 (1.87 to 6.00)
        Cycle 1 week 3 day 1 (n: 25, 1, 16)
    2.083 (0.87 to 6.00)
    2.25 (2.25 to 2.25)
    2.133 (1.78 to 4.00)
        Cycle 2 day 1 (n: 16, 0, 14)
    2.133 (1.00 to 3.58)
    99999 (99999 to 99999)
    2.083 (0.97 to 5.02)
    No statistical analyses for this end point

    Secondary: Half-life (t1/2) of AZD4573

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    End point title
    		 Half-life (t1/2) of AZD4573
    End point description
    The plasma PK of AZD4573 when administered in subjects was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint in each cohort. The arbitrary value 99999 represents that data were not available as no subjects were analysed. The median values for cycle 1 week 2 and cycle 1 week 3 in cohort 2 were not calculable due to low number of subjects. PK set included all subjects who received any amount of study intervention with at least 1 reportable concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    18
    1
    12
    Units: Hour
    median (full range (min-max))
        Cycle 1 week 1 day 1 (n: 18, 0, 9)
    5.772 (1.67 to 11.6)
    99999 (99999 to 99999)
    5.858 (3.68 to 7.90)
        Cycle 1 week 2 day 1 (n: 17, 1, 9)
    5.448 (4.10 to 11.3)
    6.80 (6.80 to 6.80)
    5.250 (4.11 to 9.71)
        Cycle 1 week 3 day 1 (n: 18, 1, 12)
    5.435 (1.15 to 10.5)
    5.09 (5.09 to 5.09)
    5.499 (3.93 to 23.5)
        Cycle 2 day 1 (n: 14, 0, 7)
    6.669 (3.50 to 16.0)
    99999 (99999 to 99999)
    4.323 (3.56 to 14.7)
    No statistical analyses for this end point

    Secondary: Systematic clearance (CL)

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    End point title
    		 Systematic clearance (CL)
    End point description
    The plasma PK of AZD4573 when administered in subjects was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint in each cohort. The arbitrary value 99999 in cycle 1 week 2 and cycle 1 week 3 represents that data were not calculable due to low number of subjects and in cycle 1 week 1 and cycle 2 represents that data were not available as no subjects were analysed. PK set included all subjects who received any amount of study intervention with at least 1 reportable concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    18
    1
    11
    Units: Liter/hour
    geometric mean (geometric coefficient of variation)
        Cycle 1 week 1 day 1 (n: 18, 0, 9)
    4.636 ( 82.9 )
    99999 ( 99999 )
    3.205 ( 59.3 )
        Cycle 1 week 2 day 1 (n: 17, 1, 9)
    5.137 ( 82.3 )
    99999 ( 99999 )
    4.537 ( 62.9 )
        Cycle 1 week 3 day 1 (n: 18, 1, 11)
    7.799 ( 69.5 )
    99999 ( 99999 )
    4.965 ( 74.7 )
        Cycle 2 day 1 (n: 14, 0, 7)
    6.367 ( 72.9 )
    99999 ( 99999 )
    6.064 ( 85.9 )
    No statistical analyses for this end point

    Secondary: Volume of distribution at terminal phase (Vz)

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    End point title
    		 Volume of distribution at terminal phase (Vz)
    End point description
    The plasma PK of AZD4573 when administered in subjects was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint in each cohort. The arbitrary value 99999 in cycle 1 week 2 and cycle 1 week 3 represents that data were not calculable due to low number of subjects and in cycle 1 week 1 and cycle 2 represents that data were not available as no subjects were analysed. PK set included all subjects who received any amount of study intervention with at least 1 reportable concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    18
    1
    11
    Units: Liter
    geometric mean (geometric coefficient of variation)
        Cycle 1 week 1 day 1 (N: 18, 0, 9)
    38.59 ( 49.0 )
    99999 ( 99999 )
    26.45 ( 54.2 )
        Cycle 1 week 2 day 1 (N: 17, 1, 9)
    45.96 ( 53.8 )
    99999 ( 99999 )
    37.68 ( 37.5 )
        Cycle 1 week 3 day 1 (N: 18, 1, 11)
    58.92 ( 33.1 )
    99999 ( 99999 )
    44.34 ( 55.7 )
        Cycle 2 day 1 (N: 14, 0, 7)
    63.45 ( 41.6 )
    99999 ( 99999 )
    43.38 ( 59.0 )
    No statistical analyses for this end point

    Secondary: Volume of distribution at steady state (Vss)

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    End point title
    		 Volume of distribution at steady state (Vss)
    End point description
    The plasma PK of AZD4573 when administered in subjects was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint in each cohort. The arbitrary value 99999 in cycle 1 week 2 and cycle 1 week 3 represents that data were not calculable due to low number of subjects and in cycle 1 week 1 and cycle 2 represents that data were not available as no subjects were analysed. PK set included all subjects who received any amount of study intervention with at least 1 reportable concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
    End point values
    		 Cohort 1 Non NK PTCL Cohort 2 NK PTCL Cohort 3 cHL
    Number of subjects analysed
    18
    1
    11
    Units: Liter
    geometric mean (geometric coefficient of variation)
        Cycle 1 week 1 day 1 (n: 18, 0, 9)
    35.80 ( 51.1 )
    99999 ( 99999 )
    24.20 ( 54.3 )
        Cycle 1 week 2 day 1 (n: 17, 1, 9)
    39.25 ( 51.3 )
    99999 ( 99999 )
    33.20 ( 36.9 )
        Cycle 1 week 3 day 1 (n: 18, 1, 11)
    50.32 ( 27.8 )
    99999 ( 99999 )
    37.99 ( 66.3 )
        Cycle 2 day 1 (n: 14, 0, 7)
    55.93 ( 36.8 )
    99999 ( 99999 )
    37.29 ( 54.6 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
    Adverse event reporting additional description
    Safety set included all subjects who received at least 1 dose of any study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Cohort 1 Non-NK PTCL
    Reporting group description
    		 Subjects with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.

    Reporting group title
    Cohort 3 cHL
    Reporting group description
    		 Subjects with cHL received 12 mg dose of AZD4573 once weekly until disease progression.

    Reporting group title
    Cohort 2 NK PTCL
    Reporting group description
    		 Subjects with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.

    Serious adverse events
    		 Cohort 1 Non-NK PTCL Cohort 3 cHL Cohort 2 NK PTCL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 31 (67.74%)
    11 / 19 (57.89%)
    2 / 2 (100.00%)
         number of deaths (all causes)
    17
    2
    1
         number of deaths resulting from adverse events
    2
    0
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 19 (5.26%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    9 / 9
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular access complication
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 19 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 19 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    4 / 31 (12.90%)
    3 / 19 (15.79%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Liver injury
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Fanconi syndrome acquired
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Staphylococcal bacteraemia
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    4 / 31 (12.90%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Tumour lysis syndrome
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1 Non-NK PTCL Cohort 3 cHL Cohort 2 NK PTCL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 31 (100.00%)
    18 / 19 (94.74%)
    2 / 2 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 19 (10.53%)
    1 / 2 (50.00%)
         occurrences all number
    2
    2
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 31 (3.23%)
    6 / 19 (31.58%)
    0 / 2 (0.00%)
         occurrences all number
    1
    6
    0
    Catheter site thrombosis
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Chills
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    5 / 31 (16.13%)
    3 / 19 (15.79%)
    1 / 2 (50.00%)
         occurrences all number
    16
    5
    1
    Pain
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Oedema peripheral
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    3
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 19 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    2
    Serum sickness
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Vulvovaginal dryness
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 19 (21.05%)
    0 / 2 (0.00%)
         occurrences all number
    2
    4
    0
    Dyspnoea
         subjects affected / exposed
    0 / 31 (0.00%)
    3 / 19 (15.79%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    Hiccups
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Tachypnoea
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Investigations
    Amylase increased
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    6
    2
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    19 / 31 (61.29%)
    11 / 19 (57.89%)
    1 / 2 (50.00%)
         occurrences all number
    90
    35
    1
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    21 / 31 (67.74%)
    11 / 19 (57.89%)
    2 / 2 (100.00%)
         occurrences all number
    101
    42
    3
    Blood cholesterol increased
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    3
    1
    0
    Blood calcium decreased
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    14 / 31 (45.16%)
    5 / 19 (26.32%)
    2 / 2 (100.00%)
         occurrences all number
    46
    18
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    5
    5
    0
    Bilirubin conjugated increased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Blood fibrinogen increased
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Prothrombin time prolonged
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Lipase increased
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Blood phosphorus decreased
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    0
    0
    Blood phosphorus increased
         subjects affected / exposed
    4 / 31 (12.90%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    6
    5
    0
    Blood potassium decreased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    5
    0
    0
    Blood potassium increased
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Blood urea increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Fibrin D dimer increased
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    10 / 31 (32.26%)
    4 / 19 (21.05%)
    0 / 2 (0.00%)
         occurrences all number
    18
    7
    0
    Serum ferritin increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Transaminases increased
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    Troponin increased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    6 / 31 (19.35%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    34
    2
    0
    Injury, poisoning and procedural complications
    Tendon rupture
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 31 (3.23%)
    3 / 19 (15.79%)
    0 / 2 (0.00%)
         occurrences all number
    1
    3
    0
    Headache
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 19 (21.05%)
    0 / 2 (0.00%)
         occurrences all number
    4
    6
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    13 / 31 (41.94%)
    4 / 19 (21.05%)
    1 / 2 (50.00%)
         occurrences all number
    43
    9
    1
    Neutropenia
         subjects affected / exposed
    24 / 31 (77.42%)
    13 / 19 (68.42%)
    1 / 2 (50.00%)
         occurrences all number
    126
    54
    1
    Lymph node pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Leukopenia
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    4
    7
    0
    Febrile neutropenia
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Anaemia
         subjects affected / exposed
    11 / 31 (35.48%)
    10 / 19 (52.63%)
    0 / 2 (0.00%)
         occurrences all number
    21
    15
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Eye pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Dry eye
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    0
    0
    Constipation
         subjects affected / exposed
    6 / 31 (19.35%)
    5 / 19 (26.32%)
    0 / 2 (0.00%)
         occurrences all number
    6
    5
    0
    Diarrhoea
         subjects affected / exposed
    12 / 31 (38.71%)
    7 / 19 (36.84%)
    0 / 2 (0.00%)
         occurrences all number
    18
    8
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    10 / 31 (32.26%)
    9 / 19 (47.37%)
    1 / 2 (50.00%)
         occurrences all number
    14
    14
    1
    Stomatitis
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    0
    Vomiting
         subjects affected / exposed
    8 / 31 (25.81%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    10
    2
    0
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    2
    2
    0
    Skin weeping
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    0
    Rash
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    3
    3
    0
    Pruritus
         subjects affected / exposed
    1 / 31 (3.23%)
    3 / 19 (15.79%)
    0 / 2 (0.00%)
         occurrences all number
    1
    3
    0
    Erythema
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Back pain
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    4
    2
    0
    Arthralgia
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Muscle spasms
         subjects affected / exposed
    4 / 31 (12.90%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    5
    1
    0
    Infections and infestations
    Enterobacter bacteraemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Bacteraemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    COVID-19
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Catheter site infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Enterococcal infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 31 (3.23%)
    3 / 19 (15.79%)
    0 / 2 (0.00%)
         occurrences all number
    1
    3
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 19 (5.26%)
    1 / 2 (50.00%)
         occurrences all number
    3
    1
    1
    Influenza
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    4 / 31 (12.90%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    0
    Streptococcal infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular device infection
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperphosphataemia
         subjects affected / exposed
    5 / 31 (16.13%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    9
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    5
    5
    0
    Hyperglycaemia
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Decreased appetite
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 19 (10.53%)
    1 / 2 (50.00%)
         occurrences all number
    2
    2
    1
    Hypervolaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    11 / 31 (35.48%)
    4 / 19 (21.05%)
    1 / 2 (50.00%)
         occurrences all number
    14
    6
    1
    Hypomagnesaemia
         subjects affected / exposed
    4 / 31 (12.90%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    5
    0
    0
    Hyponatraemia
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    4 / 31 (12.90%)
    2 / 19 (10.53%)
    0 / 2 (0.00%)
         occurrences all number
    8
    3
    0
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    8 / 31 (25.81%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
         occurrences all number
    16
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Sep 2021
    Amendment 1: Section 7.1 Discontinuation of Study Intervention - Text moved to new section 7.1.1. dedicated to study-wide stopping rules for safety. Section 7.1.1 Criteria for stopping or pausing the study recruitment - New section added to specify in greater detail study-wide stopping rules for safety that would trigger SRC evaluation and potential study pause. Section 10.1.2 Schedule of Activities, footnote c; Section 10.8.2.5 Clinical Safety Laboratory Assessments - Footnote was updated and Section 10.8.2.5 amended for clarification of the haematologic and chemistry criteria required to initiate each cycle of therapy. Section 10.4.1 Module 1 Design: AZD4573 monotherapy - Inclusion of a requirement for pooled safety monitoring assessments to be conducted at 3-monthly intervals. Section 10.6.1 Dose Modification - Update of Grade 3 or 4 non-haematological toxicities Table 11 to add the guidance of one dose level reduction in order to resume AZD4573 dosing after resolution of a Grade 4 non-haematological (excluding liver and TLS) AE to Grade 1, and guidance on discontinuation following a third occurrence.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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