Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Open-Label, Multicenter, Single-Arm, Phase II Study to Assess the Efficacy and Safety of Alectinib in Patients with ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on Prior ALK Inhibitor Therapy

    Summary
    EudraCT number
    		 2016-003924-22
    Trial protocol
    		 FR  
    Global end of trial date
    26 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2020
    First version publication date
    04 Oct 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ML39349
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03155009
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hoffmann-La Roche
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, 4070
    Public contact
    F. Hoffmann-La Roche AG, Hoffmann-La Roche, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, Hoffmann-La Roche, +41 616878333, global.trial_information@roche.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
    26 Sep 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of alectinib, in selected participants, with anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small cell lung cancer (NSCLC).
    Protection of trial subjects
    All participants were required to sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jul 2017
    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
    France: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    29
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer [AJCC] classification)

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

    Arms
    Arm title
    		 Alectinib
    Arm description
    		 Participants with confirmed NSCLC received 600 mg of oral alectinib twice daily with food.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alectinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 600 mg by mouth twice daily.

    Number of subjects in period 1
    		Alectinib
    Started
    44
    Completed
    21
    Not completed
    23
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    4
         Death
    6
         Post-treatment visit not completed
    2
         Progression of disease
    5
         Reason not specified
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Alectinib
    Reporting group description
    		 Participants with confirmed NSCLC received 600 mg of oral alectinib twice daily with food.

    Reporting group values
    		 Alectinib Total
    Number of subjects
    		 44 44
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 29 29
        From 65-84 years
    		 15 15
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.7 ( 13.6 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 25 25

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Alectinib
    Reporting group description
    		 Participants with confirmed NSCLC received 600 mg of oral alectinib twice daily with food.

    Primary: Objective Response Rate (ORR)

    		 Close Top of page
    End point title
    		 Objective Response Rate (ORR) [1]
    End point description
    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), v.1.1. CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.
    End point type
    Primary
    End point timeframe
    Up to 2 years
    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: Specified in the description. Additional information: ORR as per investigator will be descriptively summarized by the number and proportion of responders and non-responders, together with their two-sided 95% Confidence Intervals (exact CI computed using Clopper-Pearson method).
    End point values
    		 Alectinib
    Number of subjects analysed
    39
    Units: Percentage of Participants
    number (confidence interval 95%)
        Complete Response
    10.3 (2.9 to 24.2)
        Partial Response
    41.0 (25.6 to 57.9)
    No statistical analyses for this end point

    Secondary: Central Nervous System Objective Response Rate (C-ORR)

    		 Close Top of page
    End point title
    		 Central Nervous System Objective Response Rate (C-ORR)
    End point description
    C-ORR is defined as the percentage of participants who attain a CR or PR of the baseline CNS metastases based on RECIST v.1.1. CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    11
    Units: Percentage of Participants
    number (confidence interval 95%)
        Complete Response
    27.3 (6.0 to 61.0)
        Partial Response
    63.6 (30.8 to 89.1)
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

    		 Close Top of page
    End point title
    		 Progression-Free Survival (PFS)
    End point description
    PFS is defined as the time between first intake of alectinib and the first occurrence of disease progression, or death from any cause during the study, whichever occurs first. Progressive disease (PD) based on RECIST v.1.1. is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    44 [2]
    Units: Months
        median (confidence interval 95%)
    14.4 (9.2 to 9999)
    Notes
    [2] - 9999 = upper limit not estimable
    No statistical analyses for this end point

    Secondary: Time to Progression (TTP)

    		 Close Top of page
    End point title
    		 Time to Progression (TTP)
    End point description
    TTP is defined as the time between first intake of alectinib and the first occurrence of disease progression. PD based on RECIST v.1.1. is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    44 [3]
    Units: Months
        median (confidence interval 95%)
    14.9 (10.9 to 9999)
    Notes
    [3] - 9999 = upper limit not estimable
    No statistical analyses for this end point

    Secondary: Disease Control Rate

    		 Close Top of page
    End point title
    		 Disease Control Rate
    End point description
    DCR is defined as the percentage of participants who attain CR, PR, or stable disease (SD) for at least five weeks, based on RECIST v.1.1. CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum on study.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    39
    Units: Percentage of Participants
        number (confidence interval 95%)
    94.9 (82.7 to 99.4)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

    		 Close Top of page
    End point title
    		 Duration of Response (DOR)
    End point description
    DOR is defined as the time from when response (CR or PR), based on RECIST v.1.1, will be first documented to first documented disease progression or death (whichever occurs first). CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. DOR assessment is restricted to participants with a BOR of CR or PR.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    21 [4]
    Units: Months
        median (confidence interval 95%)
    9999 (9.2 to 9999)
    Notes
    [4] - 9999 = value not estimable
    No statistical analyses for this end point

    Secondary: Central Nervous System DOR (C-DOR)

    		 Close Top of page
    End point title
    		 Central Nervous System DOR (C-DOR)
    End point description
    C-DOR is defined as the time from the first observation of a CNS response of CR or PR based on RECIST V1.1 until first observation of CNS progression or death from any cause (whichever occurs first). CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. C-DOR assessment is restricted to those participants with measurable CNS metastases at baseline and with CNS BOR of CR or PR.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    10 [5]
    Units: Months
        median (confidence interval 95%)
    12.9 (2.0 to 9999)
    Notes
    [5] - 9999 = upper limit not estimable
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

    		 Close Top of page
    End point title
    		 Overall Survival (OS)
    End point description
    OS is defined as the percentage of participants alive two years after the start of treatment.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    44 [6]
    Units: Months
        median (confidence interval 95%)
    9999 (9999 to 9999)
    Notes
    [6] - 9999 = parameter not estimable due to lack of participants with event
    No statistical analyses for this end point

    Secondary: Time to Central Nervous System (CNS) Progression (TTCP)

    		 Close Top of page
    End point title
    		 Time to Central Nervous System (CNS) Progression (TTCP)
    End point description
    TTCP is defined as the time from first drug intake to first documented occurrence of disease progression in the CNS. PD based on RECIST v.1.1. is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    44 [7]
    Units: Months
        median (confidence interval 95%)
    9999 (14.9 to 9999)
    Notes
    [7] - 9999 = value not estimable
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Adverse Events (AEs)

    		 Close Top of page
    End point title
    		 Percentage of Participants with Adverse Events (AEs)
    End point description
    An adverse event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsen during the study are reported as adverse events.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    44
    Units: Percentage of Participants
    number (not applicable)
        Non-emergent
    27.3
        Emergent
    100.0
    No statistical analyses for this end point

    Secondary: Health-Related Quality of Life (QoL) as Assessed by the QLQ-C30 Questionnaire

    		 Close Top of page
    End point title
    		 Health-Related Quality of Life (QoL) as Assessed by the QLQ-C30 Questionnaire
    End point description
    The QLQ-C30 Questionnaire is used to assess the quality of life of participants with cancer. It includes five functional scales, three symptom scales, a global health status / QoL scale, and six single items. These components range in score from 0 (low response level) to 100 (high response level). This endpoint reports the average change from baseline for each domain.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    43 [8]
    Units: Percentage
    number (not applicable)
        Global health status/QoL - Improvement
    39.5
        Global health status/QoL - Stable
    48.8
        Global health status/QoL - Worsening
    11.6
        Physical Functioning (revised) score - Improvement
    34.9
        Physical Functioning (revised) score - Stable
    46.5
        Physical Functioning (revised) score - Worsening
    18.6
        Role functioning (revised) - Improvement
    48.8
        Role functioning (revised) - Stable
    34.9
        Role functioning (revised) - Worsening
    16.3
        Emotional functioning score - Improvement
    41.9
        Emotional functioning score - Stable
    44.2
        Emotional functioning score - Worsening
    14.0
        Cognitive functioning score - Improvement
    30.2
        Cognitive functioning score - Stable
    53.5
        Cognitive functioning score - Worsening
    16.3
        Social functioning score - Improvement
    44.2
        Social functioning score - Stable
    41.9
        Social functioning score - Worsening
    14.0
        Fatigue score - Improvement
    39.5
        Fatigue score - Stable
    60.5
        Fatigue score - Worsening
    20.9
        Nausea and vomiting score - Improvement
    34.9
        Nausea and vomiting score - Stable
    60.5
        Nausea and vomiting score - Worsening
    4.7
        Pain score - Improvement
    46.5
        Pain score - Stable
    32.6
        Pain score - Worsening
    20.9
        Dyspnoea score - Improvement
    41.9
        Dyspnoea score - Stable
    34.9
        Dyspnoea score - Worsening
    23.3
        Insomnia score - Improvement
    32.6
        Insomnia score - Stable
    44.2
        Insomnia score - Worsening
    23.3
        Appetite loss score - Improvement
    34.9
        Appetite loss score - Stable
    51.2
        Appetite loss score - Worsening
    14.0
        Constipation score - Improvement
    18.6
        Constipation score - Stable
    48.8
        Constipation score - Worsening
    32.6
        Diarrhoea - Improvement
    34.9
        Diarrhoea - Stable
    60.5
        Diarrhoea - Worsening
    4.7
        Financial difficulties score - Improvement
    18.6
        Financial difficulties score - Stable
    67.4
        Financial difficulties score - Worsening
    14.0
    Notes
    [8] - Global health status/QoL = revised scores
    No statistical analyses for this end point

    Secondary: Health-Related QoL as Assessed by the LC13 Questionnaire

    		 Close Top of page
    End point title
    		 Health-Related QoL as Assessed by the LC13 Questionnaire
    End point description
    The LC13 Questionnaire includes 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia), and pain medication. This scale ranges in score from 0 (low response level) to 100 (high response level). This end point reports average change from baseline in each domain.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    43 [9]
    Units: Percentage
    number (not applicable)
        Coughing score - Improvement
    30.2
        Coughing score - Stable
    48.8
        Coughing score - Worsening
    20.9
        Haemoptysis score - Stable
    97.7
        Haemoptysis score - Worsening
    2.3
        Dyspnoea score - Improvement
    30.2
        Dyspnoea score - Stable
    46.5
        Dyspnoea score - Worsening
    23.3
        Dyspnoea when resting score - Improvement
    23.3
        Dyspnoea when resting score - Stable
    60.5
        Dyspnoea when resting score - Worsening
    16.3
        Dyspnoea when walking score - Improvement
    27.9
        Dyspnoea when walking score - Stable
    46.5
        Dyspnoea when walking score - Worsening
    25.6
        Dyspnoea when stairs score - Improvement
    41.9
        Dyspnoea when stairs score - Stable
    27.9
        Dyspnoea when stairs score - Worsening
    30.2
        Sore mouth score - Improvement
    16.3
        Sore mouth score - Stable
    74.4
        Sore mouth score - Worsening
    9.3
        Dysphagia score - Improvement
    20.9
        Dysphagia score - Stable
    72.1
        Dysphagia score - Worsening
    7.0
        Peripheral neuropathy score - Improvement
    21.4
        Peripheral neuropathy score - Stable
    64.3
        Peripheral neuropathy score - Worsening
    14.3
        Alopecia score - Improvement
    9.3
        Alopecia score - Stable
    74.4
        Alopecia score - Worsening
    16.3
        Pain in chest score - Improvement
    25.6
        Pain in chest score - Stable
    58.1
        Pain in chest score - Worsening
    16.3
        Pain in arm or shoulder score - Improvement
    25.6
        Pain in arm or shoulder score - Stable
    32.6
        Pain in arm or shoulder score - Worsening
    41.9
        Pain in other parts score - Improvement
    41.5
        Pain in other parts score - Stable
    34.1
        Pain in other parts score - Worsening
    24.4
        Pain after relief medication score - Improvement
    31.6
        Pain after relief medication score - Stable
    34.1
        Pain after relief medication score - Worsening
    15.8
    Notes
    [9] - N=41 for Pain in other parts N=42 for Peripheral neuropathy N=19 for Pain relief after medication
    No statistical analyses for this end point

    Secondary: Health-Related QoL as Assessed by the BN20 Questionnaire

    		 Close Top of page
    End point title
    		 Health-Related QoL as Assessed by the BN20 Questionnaire
    End point description
    The BN20 Questionnaire includes 20 items assessing future uncertainty, visual disorder, motor dysfunction, communication deficit and other disease symptoms, and treatment toxicities. This scale ranges in score from 0 (low response level) to 100 (high response level). This endpoint reports data for the average change from baseline for each domain.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Alectinib
    Number of subjects analysed
    43 [10]
    Units: Percentage
    number (not applicable)
        Future uncertainty score - Improvement
    59.5
        Future uncertainty score - Stable
    31.0
        Future uncertainty score - Worsening
    9.5
        Headaches score - Improvement
    46.5
        Headaches score - Stable
    39.5
        Headaches score - Worsening
    14.0
        Visual disorder score - Improvement
    27.9
        Visual disorder score - Stable
    55.8
        Visual disorder score - Worsening
    16.3
        Seizures score - Improvement
    7.0
        Seizures score - Stable
    88.4
        Seizures score - Worsening
    4.7
        Motor dysfunction score - Improvement
    31.0
        Motor dysfunction score - Stable
    59.5
        Motor dysfunction score - Worsening
    9.5
        Communication deficit score - Improvement
    23.3
        Communication deficit score - Stable
    67.4
        Communication deficit score - Worsening
    9.3
        Drowsiness score - Improvement
    32.6
        Drowsiness score - Stable
    37.2
        Drowsiness score - Worsening
    30.2
        Hair loss score - Improvement
    16.3
        Hair loss score - Stable
    74.4
        Hair loss score - Worsening
    9.3
        Itchy skin score - Improvement
    7.0
        Itchy skin score - Stable
    72.1
        Itchy Skin score - Worsening
    20.9
        Weakness of legs score - Improvement
    20.9
        Weakness of legs score - Stable
    58.1
        Weakness of legs score - Worsening
    20.9
        Bladder control score - Improvement
    16.3
        Bladder control score - Stable
    58.1
        Bladder control score - Worsening
    25.6
    Notes
    [10] - N=42 for Future uncertainty and for Motor dysfunction
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Approximately 2 years
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Alectinib
    Reporting group description
    		 Participants with confirmed NSCLC received 600 mg of oral alectinib twice daily with food.

    Serious adverse events
    		 Alectinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 44 (22.73%)
         number of deaths (all causes)
    7
         number of deaths resulting from adverse events
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Right ventricular dysfunction
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Epilepsy
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Pain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Alectinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 44 (100.00%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    13 / 44 (29.55%)
         occurrences all number
    14
    Oedema peripheral
         subjects affected / exposed
    13 / 44 (29.55%)
         occurrences all number
    13
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    11 / 44 (25.00%)
         occurrences all number
    11
    Cough
         subjects affected / exposed
    8 / 44 (18.18%)
         occurrences all number
    10
    Pleural effusion
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Investigations
    Weight increased
         subjects affected / exposed
    11 / 44 (25.00%)
         occurrences all number
    11
    Blood creatine phosphokinase increased
         subjects affected / exposed
    6 / 44 (13.64%)
         occurrences all number
    7
    Blood lactate dehydrogenase increase
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Weight decreased
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Blood bilirubin increased
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 44 (27.27%)
         occurrences all number
    15
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 44 (22.73%)
         occurrences all number
    11
    Neutropenia
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    5
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    16 / 44 (36.36%)
         occurrences all number
    18
    Diarrhoea
         subjects affected / exposed
    7 / 44 (15.91%)
         occurrences all number
    7
    Nausea
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences all number
    5
    Vomiting
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Photosensitivity reaction
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences all number
    5
    Dry skin
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    4
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    14 / 44 (31.82%)
         occurrences all number
    14
    Arthralgia
         subjects affected / exposed
    8 / 44 (18.18%)
         occurrences all number
    8
    Musculoskeletal pain
         subjects affected / exposed
    6 / 44 (13.64%)
         occurrences all number
    6
    Muscle spasms
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Pain in Extremity
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    6 / 44 (13.64%)
         occurrences all number
    8
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 22:54:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA