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    Clinical Trial Results:
    A Modular Phase II, Open-Label, Multicentre Study to Assess the Efficacy and Safety of Capivasertib in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL)

    Summary
    EudraCT number
    		 2021-000870-27
    Trial protocol
    		 FR   ES   DK  
    Global end of trial date
    25 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Dec 2024
    First version publication date
    08 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D361FC00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05008055
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca Clinical study Information Center
    Sponsor organisation address
    Södertälje, Södertälje, Sweden, 151 85
    Public contact
    AstraZeneca Clinical Study Information Center, AstraZeneca Clinical Study Information Center, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca Clinical Study Information Center, +1 8772409479, 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
    22 Aug 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Aug 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the effectiveness of the module-defined study treatment by assessment of objective response rate (ORR) based on Lugano 2014 Classification response criteria in each cohort as determined by blinded independent central review (BICR).
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the International Conference on Harmonisation/Good Clinical Practice, applicable regulatory requirements, and the AstraZeneca policy on Bioethics and Human Biological Samples
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Nov 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
    Canada: 2
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    United States: 6
    Country: Number of subjects enrolled
    United Kingdom: 3
    Worldwide total number of subjects
    30
    EEA total number of subjects
    13
    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)
    15
    From 65 to 84 years
    14
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted from 3 November 2021 and analyses presented in this results form are based on a data cut-off of 22 August 2023.

    Pre-assignment
    Screening details
    		 Patients who met the inclusion and none of the exclusion criteria were enrolled to the study. This study consisted of a screening period of 28 days. All the study assessments were performed as per schedule of assessment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 R/R FL: Capivasertib monotherapy
    Arm description
    		 Patients with Relapsed or refractory Follicular Lymphoma (R/R FL) received capivasertib 480 mg orally until progression of disease (PD) or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capivasertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capivasertib was taken at 480 mg orally twice a day (BD) until disease progression or unacceptable toxicity.

    Arm title
    		 R/R MZL: Capivasertib monotherapy
    Arm description
    		 Patients with Relapsed or refractory Marginal zone lymphoma (R/R MZL) received capivasertib 480 mg orally until PD or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capivasertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capivasertib was taken at 480 mg orally BD until disease progression or unacceptable toxicity.

    Arm title
    		 R/R MCL: Capivasertib monotherapy
    Arm description
    		 Patients with Relapsed or refractory Mantle cell lymphoma (R/R MCL) received capivasertib 480 mg orally until PD or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capivasertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capivasertib was taken at 480 mg orally BD until disease progression or unacceptable toxicity.

    Number of subjects in period 1
    		R/R FL: Capivasertib monotherapy R/R MZL: Capivasertib monotherapy R/R MCL: Capivasertib monotherapy
    Started
    16
    4
    10
    Completed
    13
    3
    9
    Not completed
    3
    1
    1
         Patients ongoing treatment as of 22 August 2023.
    3
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    R/R FL: Capivasertib monotherapy
    Reporting group description
    		 Patients with Relapsed or refractory Follicular Lymphoma (R/R FL) received capivasertib 480 mg orally until progression of disease (PD) or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.

    Reporting group title
    R/R MZL: Capivasertib monotherapy
    Reporting group description
    		 Patients with Relapsed or refractory Marginal zone lymphoma (R/R MZL) received capivasertib 480 mg orally until PD or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.

    Reporting group title
    R/R MCL: Capivasertib monotherapy
    Reporting group description
    		 Patients with Relapsed or refractory Mantle cell lymphoma (R/R MCL) received capivasertib 480 mg orally until PD or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.

    Reporting group values
    		 R/R FL: Capivasertib monotherapy R/R MZL: Capivasertib monotherapy R/R MCL: Capivasertib monotherapy Total
    Number of subjects
    		 16 4 10 30
    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)
    		 12 1 2 15
        From 65-84 years
    		 4 3 7 14
        85 years and over
    		 0 0 1 1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 55.7 ( 12.07 ) 66.8 ( 4.92 ) 76.2 ( 9.72 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 7 2 4 13
        Male
    		 9 2 6 17
    Race, Customised
    Units: Subjects
        Asian
    		 5 0 0 5
        White
    		 10 3 7 20
        Other
    		 0 1 1 2
        Not reported
    		 1 0 2 3
    Ethnicity, Customised
    Units: Subjects
        Hispanic or Latino
    		 3 0 0 3
        Not Hispanic or Latino
    		 12 4 5 21
        Missing
    		 0 0 4 4
        Other
    		 1 0 1 2

    End points

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    End points reporting groups
    Reporting group title
    R/R FL: Capivasertib monotherapy
    Reporting group description
    		 Patients with Relapsed or refractory Follicular Lymphoma (R/R FL) received capivasertib 480 mg orally until progression of disease (PD) or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.

    Reporting group title
    R/R MZL: Capivasertib monotherapy
    Reporting group description
    		 Patients with Relapsed or refractory Marginal zone lymphoma (R/R MZL) received capivasertib 480 mg orally until PD or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.

    Reporting group title
    R/R MCL: Capivasertib monotherapy
    Reporting group description
    		 Patients with Relapsed or refractory Mantle cell lymphoma (R/R MCL) received capivasertib 480 mg orally until PD or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.

    Primary: Objective response rate

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    End point title
    		 Objective response rate [1]
    End point description
    Objective response rate is defined as the proportion of patients achieving either complete response (CR) or partial response (PR) according to the Lugano 2014 Classification for non-Hodgkin lymphoma (NHL) as assessed by blinded independent central review (BICR). The endpoint included response evaluable analysis set which included all patients, treated with study treatment, with measurable disease at baseline.
    End point type
    Primary
    End point timeframe
    First dose until progression of disease [PD] or last evaluable assessment in the absence of progression or data cut-off date (21.6 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
    		 R/R FL: Capivasertib monotherapy R/R MZL: Capivasertib monotherapy R/R MCL: Capivasertib monotherapy
    Number of subjects analysed
    16
    3
    10
    Units: Percentage of Patients
        number (confidence interval 95%)
    18.8 (4.0 to 45.6)
    33.3 (0.8 to 90.6)
    30.0 (6.7 to 65.2)
    No statistical analyses for this end point

    Secondary: Duration of response

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    End point title
    		 Duration of response
    End point description
    Duration of response is defined as the time from the date of first documented response until date of documented progression according to the Lugano 2014 Classification for NHL as assessed by BICR, or death due to any cause. The arbitary value 9999.9999, and 0.9999 represents data that data were not calculable due to a low number of patients. The endpoint included response evaluable analysis set which included all patients, treated with study treatment, with measurable disease at baseline.
    End point type
    Secondary
    End point timeframe
    First documented response until date of documented progression or data-cut off date (21.6 Months)
    End point values
    		 R/R FL: Capivasertib monotherapy R/R MZL: Capivasertib monotherapy R/R MCL: Capivasertib monotherapy
    Number of subjects analysed
    3
    1
    3
    Units: Months
        median (confidence interval 95%)
    1.9 (1.7 to 9999.9999)
    9999.9999 (9999.9999 to 9999.9999)
    1.9 (0.9999 to 9999.9999)
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    Progression-free survival is defined as the time from the date of first dose until documented disease progression according to the Lugano 2014 Classification for NHL as assessed by BICR, or death due to any cause. The analysis included all dosed patients, regardless of whether the patient withdrew from therapy, received another anti lymphoma therapy, or clinically progressed prior to progression according to the Lugano 2014 Classification for NHL. The arbitary value 9999.9999 represents that upper limit of the 95% confidence interval (CI) was not reached due to the insufficient number of patients with events, and the short duration of follow-up. The endpoint included safety analysis set which included all patients who received any amount of study treatment.
    End point type
    Secondary
    End point timeframe
    First dose until documented disease progression or data cut-off date (21.6 Months)
    End point values
    		 R/R FL: Capivasertib monotherapy R/R MZL: Capivasertib monotherapy R/R MCL: Capivasertib monotherapy
    Number of subjects analysed
    16
    4
    10
    Units: Months
        median (confidence interval 95%)
    5.4 (3.4 to 9999.9999)
    9999.9999 (1.4 to 9999.9999)
    1.9 (0.9 to 9999.9999)
    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 time from the date of first dose until the date of death due to any cause. The analysis included all dosed patients, regardless of whether the patient withdrew from therapy or received another anti lymphoma therapy. Patients who had not died by the analysis DCO date were censored at their last known date of being alive before the DCO date. Patients who were known to be alive or dead after the DCO date were censored at the DCO date. Patients who were lost to follow-up were censored at the date when they were last known to have been alive. The arbitary value 9999.9999 represents that median, and 95% CI could not be calculated as no patients were seen to experience the event of interest due to short duration of follow-up, and as they were not reached. The endpoint included safety analysis set which included all patients who received any amount of study treatment.
    End point type
    Secondary
    End point timeframe
    First dose until data cut-off date (21.6 Months)
    End point values
    		 R/R FL: Capivasertib monotherapy R/R MZL: Capivasertib monotherapy R/R MCL: Capivasertib monotherapy
    Number of subjects analysed
    16
    4
    10
    Units: Months
        median (confidence interval 95%)
    9999.9999 (9999.9999 to 9999.9999)
    9999.9999 (1.4 to 9999.9999)
    9999.9999 (2.0 to 9999.9999)
    No statistical analyses for this end point

    Secondary: Number of patients with adverse events and serious adverse events

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    End point title
    		 Number of patients with adverse events and serious adverse events
    End point description
    The safety and tolerability of the capivasertib treatment in each Cohort was assessed.
    End point type
    Secondary
    End point timeframe
    Screening (Day -28 to -1) until Post-treatment follow-up up to 30 days after last dose or long-term follow-up or study completion (Every 12 weeks until death or lost to follow-up, unless patient have withdrawn consent [up to 21.6 Months])
    End point values
    		 R/R FL: Capivasertib monotherapy R/R MZL: Capivasertib monotherapy R/R MCL: Capivasertib monotherapy
    Number of subjects analysed
    16
    4
    10
    Units: Participants
        Any adverse event (AE)
    16
    3
    10
        Any AE possibly related to treatment
    14
    3
    8
        Any AE of CTCAE grade 3 or higher
    7
    1
    7
        CTCAE ≥ grade 3 AEs, possibly treatment-related
    3
    1
    5
        Any AE with outcome = death
    0
    0
    0
        Possibly treatment-related AE with outcome =death
    0
    0
    0
        Any SAE (including events with outcome = death)
    2
    0
    3
        Possibly treatment-related SAEs (including deaths)
    0
    0
    3
    No statistical analyses for this end point

    Secondary: Plasma concentration of capivasertib overtime

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    End point title
    		 Plasma concentration of capivasertib overtime
    End point description
    The plasma concentration of capivasertib when administered in patients in each Cohort was determined. The arbitary vaue 9999.9999 represents that geometric mean was not quantified because in given time point, when less than or equal to 50% of the concentration values were not measurable or quantified. The endpoint included pharmacokinetic (PK) analysis set which included all patients who received at least 1 dose of capivasertib, for whom there is at least 1 reportable PK concentration. CTCAE: Common Terminology Criteria for Adverse Events.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (28-day treatment Cycle) Day 1 and on Cycle 1 Day 8, Cycle 1 Day 15 and Cycle 1 Day 22 (Pre-dose and post-dose)
    End point values
    		 R/R FL: Capivasertib monotherapy R/R MZL: Capivasertib monotherapy R/R MCL: Capivasertib monotherapy
    Number of subjects analysed
    16
    4
    9
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1 Day 1 (Post-dose [1 hour])
    394.9 ( 157.0 )
    414.4 ( 125.7 )
    287.1 ( 676.2 )
        Cycle 1 Day 1 (Post-dose [2 hours])
    883.7 ( 59.12 )
    962.9 ( 40.33 )
    976.1 ( 58.27 )
        Cycle 1 Day 1 (Post-dose [4 hours])
    528.5 ( 49.28 )
    677.2 ( 65.77 )
    780.1 ( 56.99 )
        Cycle 1 Day 8 (Pre-dose)
    6.149 ( 207.4 )
    8.477 ( 103.9 )
    14.31 ( 138.8 )
        Cycle 1 Day 15 (Pre-dose)
    5.844 ( 146.1 )
    9.245 ( 73.63 )
    32.36 ( 373.5 )
        Cycle 1 Day 22 (Pre-dose)
    7.974 ( 372.2 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening (Day -28 to -1) until Post-treatment follow-up up to 30 days after last dose or long-term follow-up or study completion (Every 12 weeks until death or lost to follow-up, unless patient have withdrawn consent [up to 21.6 Months])
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    R/R FL: Capivasertib monotherapy
    Reporting group description
    		 Patients with Relapsed or refractory Follicular Lymphoma (R/R FL) received capivasertib 480 mg orally until progression of disease (PD) or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.

    Reporting group title
    R/R MCL: Capivasertib monotherapy (Experimental)
    Reporting group description
    		 Patients with Relapsed or refractory Mantle cell lymphoma (R/R MCL) received capivasertib 480 mg orally until PD or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.

    Reporting group title
    R/R MZL: Capivasertib monotherapy
    Reporting group description
    		 Patients with Relapsed or refractory Marginal zone lymphoma (R/R MZL) received capivasertib 480 mg orally until PD or unacceptable toxicity, or if the patient/investigator requests to stop the treatment.

    Serious adverse events
    		 R/R FL: Capivasertib monotherapy R/R MCL: Capivasertib monotherapy (Experimental) R/R MZL: Capivasertib monotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 16 (12.50%)
    3 / 10 (30.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    2
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (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
    Respiratory, thoracic and mediastinal disorders
    Obliterative bronchiolitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (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
    Skin and subcutaneous tissue disorders
    Erythema multiforme
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (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
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (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
    Perirectal abscess
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (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
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 R/R FL: Capivasertib monotherapy R/R MCL: Capivasertib monotherapy (Experimental) R/R MZL: Capivasertib monotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 16 (100.00%)
    9 / 10 (90.00%)
    3 / 4 (75.00%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Haemorrhage
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 10 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    2
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Asthenia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 10 (10.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    1
    Fatigue
         subjects affected / exposed
    3 / 16 (18.75%)
    2 / 10 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    5
    2
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Haemoptysis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Pleural effusion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Anosmia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Headache
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    4
    0
    1
    Memory impairment
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Neutrophilia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    5
    0
    0
    Lymphocytosis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Anaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    3
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Ocular discomfort
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    15 / 16 (93.75%)
    4 / 10 (40.00%)
    2 / 4 (50.00%)
         occurrences all number
    29
    8
    3
    Dry mouth
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Intussusception
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    2 / 16 (12.50%)
    5 / 10 (50.00%)
    2 / 4 (50.00%)
         occurrences all number
    2
    6
    2
    Odynophagia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Proctalgia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 10 (10.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    2
    1
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Night sweats
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    0
    Rash
         subjects affected / exposed
    2 / 16 (12.50%)
    3 / 10 (30.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    7
    0
    Rash maculo-papular
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    6
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    0
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    4
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    COVID-19
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    1
    Wound abscess
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    3
    0
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 10 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    3
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 10 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Decreased appetite
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 10 (10.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Apr 2021
    Amendment 01: Exclusion criteria amended to exclude patients with increased risk of venous thromboembolism (VTE) not willing to receive VTE prophylaxis and to exclude the concomitant use of UGT2B7 inhibitors/inducers. Additional information added on dietary restrictions with capivasertib. Module I updated: to include further details on the selection of the dose for capivasertib monotherapy and to provide the rationale for the proposed intermittent dosing schedule. Inclusion criteria updated to include the current need for systemic treatment and to clarify that all patients (with FL, MZL, or MCL depending upon Cohort) must have had relapsed, progressed, or be refractory after at least 2 prior lines of systemic therapy instead of one. Exclusion criterion updated to exclude patients with an immediate need for cytoreductive treatment.
    28 Jul 2021
    Amendment 02: In Module I inclusion criteria updated to clarify that physicians should discuss CAR-T cell therapy for R/R FL and MCL patients prior to study enrolment.
    24 Feb 2022
    Amendment 03: Inclusion criterion number 6 updated to clarify that the that pregnancy test should be done on a serum sample. Text added regarding bone marrow aspirates/biopsy performed as part of standard of care and up to 12 weeks prior to informed consent form signature. Removal of urinary tract infection, pneumonia, and Torsades de pointes from the AESI list. Addition of infective pneumonia. Updated in line with current list of AESIs for capivasertib. Inclusion criteria updated to delete text stating the maximum number of prior lines of therapy (for patients with R/R FL, MZL, or MCL depending upon Cohort).

    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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