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    Clinical Trial Results:
    A Modular Phase IIa Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients with Advanced Cancer Whose Tumours Contain Molecular Alterations (PLANETTE)

    Summary
    EudraCT number
    		 2020-002529-27
    Trial protocol
    		 FR  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Feb 2026
    First version publication date
    25 Feb 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5339C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04564027
    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
    Interim
    Date of interim/final analysis
    28 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Apr 2023
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To obtain a preliminary assessment of the efficacy of ceralasertib in participants with Ataxia telangiectasia mutated (ATM)-altered advanced solid tumour (aST) refractory to standard treatments options, as assessed by Objective response rate (ORR).
    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. Before enrollment of any patient into the study, the final protocol, including the final version of the informed consent form, was approved by the national regulatory authority or a notification to the national regulatory authority was done, according to local regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2020
    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
    Spain: 5
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    United States: 30
    Worldwide total number of subjects
    54
    EEA total number of subjects
    24
    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)
    17
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled in this study from 01 December 2020 to 04 April 2023 at 18 centers in 3 countries.

    Pre-assignment
    Screening details
    		 The screening comprised of 2 parts, Part 1 and Part 2, which applied for both Cohort A and Cohort B. Participants meeting the inclusion criteria were enrolled in the study. All the assessments were performed as per the schedule of the assessments.

    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
    		 Cohort A (aST): 240 mg of Ceralasertib
    Arm description
    		 Participants with Ataxia telangiectasia mutated (ATM) altered Advanced solid tumour (aST) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    240 mg of Ceralasertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 240 mg of ceralasertib in the Cohort A of the study

    Arm title
    		 Cohort A (aST): 160 mg of Ceralasertib
    Arm description
    		 Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    160 mg of ceralasertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 160 mg of ceralasertib in the Cohort A of the study

    Arm title
    		 Cohort B (mCRPC): 240 mg of Ceralasertib
    Arm description
    		 Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    240 mg of ceralasertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 240 mg of ceralasertib in the Cohort B of the study

    Arm title
    		 Cohort B (mCRPC): 160 mg of Ceralasertib
    Arm description
    		 Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    160 mg of ceralasertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 160 mg of ceralasertib in the Cohort B of the study

    Number of subjects in period 1
    		Cohort A (aST): 240 mg of Ceralasertib Cohort A (aST): 160 mg of Ceralasertib Cohort B (mCRPC): 240 mg of Ceralasertib Cohort B (mCRPC): 160 mg of Ceralasertib
    Started
    8
    30
    1
    15
    Completed
    8
    27
    1
    15
    Not completed
    0
    3
    0
    0
         Ongoing treatment as of 28Apr23
    -
    3
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A (aST): 240 mg of Ceralasertib
    Reporting group description
    		 Participants with Ataxia telangiectasia mutated (ATM) altered Advanced solid tumour (aST) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Reporting group title
    Cohort A (aST): 160 mg of Ceralasertib
    Reporting group description
    		 Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Reporting group title
    Cohort B (mCRPC): 240 mg of Ceralasertib
    Reporting group description
    		 Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Reporting group title
    Cohort B (mCRPC): 160 mg of Ceralasertib
    Reporting group description
    		 Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Reporting group values
    		 Cohort A (aST): 240 mg of Ceralasertib Cohort A (aST): 160 mg of Ceralasertib Cohort B (mCRPC): 240 mg of Ceralasertib Cohort B (mCRPC): 160 mg of Ceralasertib Total
    Number of subjects
    		 8 30 1 15 54
    Age Categorical
    Units: Participants
        18-64
    		 3 11 0 3 17
        65-84
    		 5 19 1 12 37
        ≥ 85
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.1 ( 10.92 ) 65.5 ( 11.0 ) 0 ( 0 ) 70.7 ( 7.46 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 5 14 0 0 19
        Male
    		 3 16 1 15 35
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    		 0 0 0 0 0
        Native Hawaiin or Other Pacific Islander
    		 0 0 0 0 0
        White
    		 8 11 0 6 25
        Not Reported
    		 0 7 0 4 11
        Missing
    		 0 9 0 5 14
        Other
    		 0 3 1 0 4
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 0 3 0 1 4
        Not Hispanic or Latino
    		 8 13 1 9 31
        Missing.
    		 0 14 0 5 19

    End points

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    End points reporting groups
    Reporting group title
    Cohort A (aST): 240 mg of Ceralasertib
    Reporting group description
    		 Participants with Ataxia telangiectasia mutated (ATM) altered Advanced solid tumour (aST) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Reporting group title
    Cohort A (aST): 160 mg of Ceralasertib
    Reporting group description
    		 Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Reporting group title
    Cohort B (mCRPC): 240 mg of Ceralasertib
    Reporting group description
    		 Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Reporting group title
    Cohort B (mCRPC): 160 mg of Ceralasertib
    Reporting group description
    		 Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Primary: Cohort A (aST): Objective response rate (ORR)

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    End point title
    		 Cohort A (aST): Objective response rate (ORR) [1] [2]
    End point description
    ORR is defined as the percentage of participants who have at least one response of complete response (CR) or partial response (PR) prior to any evidence of progression (as defined by response evaluation criteria in solid tumours [RECIST] 1.1) that is confirmed at least 4 weeks later. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. Evaluable for response set included all participants who were Molecularly Eligible Centrally Confirmed evaluable for response set with measurable disease at baseline and who received at least 1 dose of study intervention. Due to an increased frequency and early onset of Grade≥3 hematological toxicity on receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg were not included in the efficacy analyses for both study cohorts.
    End point type
    Primary
    End point timeframe
    2 years 4 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 formal hypothesis testing was conducted and therefore has not been presented here.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal hypothesis testing was conducted and therefore has not been presented here.
    End point values
    		 Cohort A (aST): 160 mg of Ceralasertib
    Number of subjects analysed
    28
    Units: Percentage of participants
        number (confidence interval 80%)
    7.14 (1.9 to 17.9)
    No statistical analyses for this end point

    Primary: Cohort B (mCRPC): Composite response rate

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    End point title
    		 Cohort B (mCRPC): Composite response rate [3] [4]
    End point description
    Composite response rate is defined as the investigator assessed radiological response by RECIST 1.1 for soft tissue and visceral lesions and Prostate Cancer Working Group 3 (PCWG3) for bone lesions, confirmed prostate specific antigen (PSA) decline of more than 50%, and/or confirmed circulating tumour cell [CTC] conversion from unfavorable (>=5 cells/7.5 ml blood) to favorable (<5 cells). Evaluable for response set included all participants who were Molecularly Eligible Centrally Confirmed evaluable for response set with measurable disease at baseline and who received at least 1 dose of study intervention. Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
    End point type
    Primary
    End point timeframe
    Up to 2 years 4 months
    Notes
    [3] - 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 formal hypothesis testing was conducted and therefore has not been presented here.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal hypothesis testing was conducted and therefore has not been presented here.
    End point values
    		 Cohort B (mCRPC): 160 mg of Ceralasertib
    Number of subjects analysed
    13
    Units: Percentage of participants
        number (confidence interval 80%)
    7.7 (0.8 to 26.8)
    No statistical analyses for this end point

    Secondary: Cohort A (aST): Duration of Radiological response (DoR)

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    End point title
    		 Cohort A (aST): Duration of Radiological response (DoR) [5]
    End point description
    DoR is defined as the time from the date of first documented response (confirmed CR/PR) until date of documented progression or death in the absence of disease progression. Molecularly eligible centrally confirmed evaluable for response set included all participants who were MolecularlyEligible Centrally Confirmed with measurable baseline disease and who received at least 1 dose of study intervention. The number of responders who subsequently progressed or died was 0, therefore, efficacy analysis was not conducted for Duration of response (DoR).
    End point type
    Secondary
    End point timeframe
    Up to 2 years 4 months
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal hypothesis testing was conducted and therefore has not been presented here.
    End point values
    		 Cohort A (aST): 160 mg of Ceralasertib
    Number of subjects analysed
    0 [6]
    Units: Months
        median (inter-quartile range (Q1-Q3))
    ( to )
    Notes
    [6] - No subject was analyzed for Duration of Radiological response in Cohort A.
    No statistical analyses for this end point

    Secondary: Cohort A (aST): Progression free survival (PFS)

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    End point title
    		 Cohort A (aST): Progression free survival (PFS) [7]
    End point description
    PFS is defined as the time from start of study intervention until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy prior to progression. Molecularly eligible centrally confirmed set included all participants who were Molecularly Eligible Centrally Confirmed and who received at least 1 dose of study intervention. Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
    End point type
    Secondary
    End point timeframe
    Up to 2 years 4 months
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal hypothesis testing was conducted and therefore has not been presented here.
    End point values
    		 Cohort A (aST): 160 mg of Ceralasertib
    Number of subjects analysed
    28
    Units: Months
        median (confidence interval 80%)
    3.7 (1.9 to 5.6)
    No statistical analyses for this end point

    Secondary: Cohort A (aST): Percentage change in tumor size

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    End point title
    		 Cohort A (aST): Percentage change in tumor size [8]
    End point description
    Percentage change in tumour size is defined as the reduction from baseline or the increase from baseline in the absence of a reduction in the sum of the longest diameters (or the short axis measurements for lymph nodes) of the target lesions. A negative change denotes a reduction in target lesion size. In the data presentation table, the arbitary value 9.999, 9.9999 represents the data where data was not calculable as there were insufficient number of participants and the descriptive statistics cannot be calculated. Molecularly eligible centrally confirmed evaluable for response set included all participants who were Molecularly Eligible Centrally Confirmed with measurable baseline disease and who received at least 1 dose of study intervention. Percentage change in tumor size was conducted every 8 weeks after the start of the treatment up to 1 year, then every 12 weeks until objective disease progression as per RECIST 1.1 or PCWG3 criteria.
    End point type
    Secondary
    End point timeframe
    Scan Visits 1 (Week 8), 2 (Week 16), 3 (Week 24), 4 (Week 32), 5 (Week 40), 6 (Week (48), 7 (Week 56)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal hypothesis testing was conducted and therefore has not been presented here.
    End point values
    		 Cohort A (aST): 240 mg of Ceralasertib Cohort A (aST): 160 mg of Ceralasertib
    Number of subjects analysed
    5
    28
    Units: Percentage change
    arithmetic mean (standard deviation)
        Week 8 Cohort A: N= 23 Cohort B: N= 4
    6.2 ( 10.99 )
    6.6 ( 22.45 )
        Week 16 Cohort A: N= 13 Cohort B: N= 1
    5.4 ( 9.9999 )
    -4.7 ( 16.83 )
        Week 24 Cohort A: N= 10 Cohort B: N= 0
    9.999 ( 9.9999 )
    -12.8 ( 21.47 )
        Week 32 Cohort A: N= 5 Cohort B: N= 0
    9.999 ( 9.9999 )
    -17.9 ( 34.41 )
        Week 40 Cohort A: N= 1 Cohort B: N= 0
    9.999 ( 9.9999 )
    -1.1 ( 9.9999 )
        Week 48 Cohort A: N= 1 Cohort B: N= 0
    9.999 ( 9.9999 )
    -100 ( 9.9999 )
        Week 56 Cohort A: N= 1 Cohort B: N= 0
    9.999 ( 9.9999 )
    -100 ( 9.9999 )
    No statistical analyses for this end point

    Secondary: Cohort B (mRCPC): Percentage change in tumor size

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    End point title
    		 Cohort B (mRCPC): Percentage change in tumor size [9]
    End point description
    Percentage change in tumour size is defined as the reduction from baseline or the increase from baseline in the absence of a reduction in the sum of the longest diameters (or the short axis measurements for lymph nodes) of the target lesions. A negative change denotes a reduction in target lesion size. Molecularly eligible centrally confirmed evaluable for response set included all participants who were Molecularly Eligible Centrally Confirmed with measurable baseline disease and who received at least 1 dose of study intervention. Percentage change in tumor size was conducted every 8 weeks after the start of the treatment up to 1 year, then every 12 weeks until objective disease progression as per RECIST 1.1 or PCWG3 criteria. Due to an increased frequency and early onset of Grade≥3 hematological toxicity on receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg were not included in the efficacy analyses for both study cohorts.
    End point type
    Secondary
    End point timeframe
    Scan Visits 1 (Week 8), 2 (Week 16), 3 (Week 24), 4 (Week 32)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal hypothesis testing was conducted and therefore has not been presented here.
    End point values
    		 Cohort B (mCRPC): 160 mg of Ceralasertib
    Number of subjects analysed
    11
    Units: Percentage change
    arithmetic mean (standard deviation)
        Scan Visit 1 (Week 8) N=8
    2.0 ( 21.35 )
        Scan Visit 2 (Week 16) N=4
    -6.0 ( 9.37 )
        Scan Visit 3 (Week 24) N=2
    -1.4 ( 11.75 )
        Scan Visit 4 (Week 32) N=2
    -5.2 ( 13.21 )
    No statistical analyses for this end point

    Secondary: Cohort A (aST) and B (mCRPC): Number of participants with serious and non-serious adverse events

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    End point title
    		 Cohort A (aST) and B (mCRPC): Number of participants with serious and non-serious adverse events
    End point description
    The adverse events as a variable of safety and tolerability after admiration of ceralasertib was determined. CTCAE= Common Terminology Criteria for Adverse Events; IP=investigational product
    End point type
    Secondary
    End point timeframe
    Up to 2 years 4 months
    End point values
    		 Cohort A (aST): 240 mg of Ceralasertib Cohort A (aST): 160 mg of Ceralasertib Cohort B (mCRPC): 240 mg of Ceralasertib Cohort B (mCRPC): 160 mg of Ceralasertib
    Number of subjects analysed
    8
    30
    1
    15
    Units: Participants
        All Adverse events (AE)
    8
    30
    1
    15
        Any AE possibly related to treatment
    8
    21
    1
    13
        Any AE of CTCAE Grade 3 or higher
    6
    15
    1
    8
        Any AE of CTCAE grade 3 or higher, related to IP
    4
    6
    1
    5
        Any AE with outcome of death
    0
    0
    1
    0
        Any AE with outcome = death related to IP
    0
    0
    1
    0
        Any SAE (including events with outcome = death)
    6
    4
    1
    4
        Any SAE (events outcome =death) related to IP
    3
    2
    1
    1
        Any SAE leading to discontinuation of IP
    0
    1
    1
    0
        IP-related SAE leading to discontinuation
    0
    0
    1
    0
        Any AE leading to discontinuation of IP
    0
    1
    1
    1
        IP-related AE leading to discontinuation
    0
    0
    1
    1
        Any AE leading to dose modification
    4
    10
    1
    5
        Any AE leading to dose reduction
    1
    4
    0
    3
        Any AE leading to dose interruption
    4
    7
    1
    3
        Any AE leading to dosing cycle delays
    1
    0
    0
    1
        Any other significant AEs
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose)
    Adverse event reporting additional description
    Safety analysis consist of all participants who received at least 1 dose of study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Cohort A (aST): 240 mg of Ceralasertib
    Reporting group description
    		 Participants with Ataxia telangiectasia mutated (ATM) altered Advanced solid tumour (aST) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Reporting group title
    Cohort A (aST): 160 mg of Ceralasertib
    Reporting group description
    		 Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Reporting group title
    Cohort B (mCRPC): 240 mg of Ceralasertib
    Reporting group description
    		 Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Reporting group title
    Cohort B (mCRPC): 160 mg of Ceralasertib
    Reporting group description
    		 Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.

    Serious adverse events
    		 Cohort A (aST): 240 mg of Ceralasertib Cohort A (aST): 160 mg of Ceralasertib Cohort B (mCRPC): 240 mg of Ceralasertib Cohort B (mCRPC): 160 mg of Ceralasertib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    4 / 30 (13.33%)
    1 / 1 (100.00%)
    4 / 15 (26.67%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Platelet count decreased
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    1 / 1 (100.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 30 (3.33%)
    1 / 1 (100.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort A (aST): 240 mg of Ceralasertib Cohort A (aST): 160 mg of Ceralasertib Cohort B (mCRPC): 240 mg of Ceralasertib Cohort B (mCRPC): 160 mg of Ceralasertib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    30 / 30 (100.00%)
    1 / 1 (100.00%)
    15 / 15 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 8 (50.00%)
    8 / 30 (26.67%)
    1 / 1 (100.00%)
    5 / 15 (33.33%)
         occurrences all number
    4
    8
    2
    5
    Asthenia
         subjects affected / exposed
    0 / 8 (0.00%)
    7 / 30 (23.33%)
    0 / 1 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    7
    0
    2
    Chest pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Facial pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    oedema peripheral
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Mucosal discolouration
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    1 / 1 (100.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    1
    Reproductive system and breast disorders
    Penile pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Pelvic pain
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 30 (6.67%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 8 (25.00%)
    3 / 30 (10.00%)
    1 / 1 (100.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    3
    2
    0
    Dyspnoea
         subjects affected / exposed
    4 / 8 (50.00%)
    4 / 30 (13.33%)
    1 / 1 (100.00%)
    2 / 15 (13.33%)
         occurrences all number
    5
    5
    2
    2
    Hypoxia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pleural effusion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 30 (6.67%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    1 / 1 (100.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    0
    1
    Anxiety
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 30 (3.33%)
    1 / 1 (100.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 30 (6.67%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    0
    1
    Platelet count increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 30 (6.67%)
    1 / 1 (100.00%)
    1 / 15 (6.67%)
         occurrences all number
    2
    4
    1
    1
    Neutrophil count decreased
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 30 (6.67%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 8 (0.00%)
    4 / 30 (13.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    7
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 8 (25.00%)
    3 / 30 (10.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    5
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 30 (10.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Palpitation
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Dysguesia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    2
    Dizziness
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 30 (6.67%)
    0 / 1 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    0
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dysarthria
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sensory disturbance
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Neuralgia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 30 (10.00%)
    0 / 1 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    1
    3
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 8 (75.00%)
    8 / 30 (26.67%)
    0 / 1 (0.00%)
    6 / 15 (40.00%)
         occurrences all number
    8
    10
    0
    8
    Thrombocytopenia
         subjects affected / exposed
    1 / 8 (12.50%)
    6 / 30 (20.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    8
    0
    0
    Leukopenia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    1 / 1 (100.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    2
    Neutropenia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    1 / 1 (100.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    1
    2
    Lymph node pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Periorbital oedema
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Scleral haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 8 (12.50%)
    5 / 30 (16.67%)
    1 / 1 (100.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    9
    2
    0
    Constipation
         subjects affected / exposed
    2 / 8 (25.00%)
    7 / 30 (23.33%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    2
    7
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 30 (6.67%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    0
    1
    Abdominal pain
         subjects affected / exposed
    2 / 8 (25.00%)
    9 / 30 (30.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    2
    9
    0
    1
    Vomiting
         subjects affected / exposed
    3 / 8 (37.50%)
    5 / 30 (16.67%)
    0 / 1 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    3
    6
    0
    2
    Stomatitis
         subjects affected / exposed
    1 / 8 (12.50%)
    5 / 30 (16.67%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    5
    0
    0
    Nausea
         subjects affected / exposed
    4 / 8 (50.00%)
    13 / 30 (43.33%)
    0 / 1 (0.00%)
    8 / 15 (53.33%)
         occurrences all number
    5
    14
    0
    10
    Dysphagia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 30 (6.67%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Melaena
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Anorectal disorder
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Hepatobiliary disorders
    Hepatic cytolysis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 30 (10.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritis
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 30 (10.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Skin mass
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Actinic keratosis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 30 (10.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    3
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    2
    Musculoskeletal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Back pain
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 30 (10.00%)
    0 / 1 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    1
    3
    0
    2
    Muscular weakness
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    1 / 1 (100.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Pain in extremity
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 30 (3.33%)
    0 / 1 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    1
    1
    0
    2
    Spinal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Groin pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Oral fungal infection
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 30 (6.67%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    0
    COVID-19
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Herpes simplex reactivation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    2
    Rhinitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Device related infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Skin infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Appetite disorder
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    2 / 8 (25.00%)
    6 / 30 (20.00%)
    1 / 1 (100.00%)
    3 / 15 (20.00%)
         occurrences all number
    2
    6
    2
    3
    Dehydration
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 30 (3.33%)
    1 / 1 (100.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 30 (10.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    4
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    1
    0
    0
    2
    Hyperphosphataemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Folate deficiency
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 30 (0.00%)
    0 / 1 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Hyponatraemia
         subjects affected / exposed
    2 / 8 (25.00%)
    4 / 30 (13.33%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    8
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Aug 2020
    In the amendment 1, the test "discontinuation" was added to the table title, definition of prolonged Grade 2 toxicity, the text "Grade 2" for thrombocytopenia under Grade 2 events and addition of Grade 3-4 neutropenia or Grade 4 anaemia” under Grade 3-4 toxicity were added.
    04 Nov 2022
    This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union. In Section 6.1 (Intervention after the final DCO) and Section 11.6.7 (Intervention after the Final DCO) text was added to clarify options for continuation of treatment for patients receiving benefit at time of final DCO.
    27 May 2024
    New section/text related to study disruption, clarification of sample size following dose reduction to 160 mg BID in the synopsis, Update following dose reduction to 160 mg BID in the schema, to provide clarification for ATM mutation definition in Appendix K.

    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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