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    Clinical Trial Results:
    A phase II, open-label, single-arm decentralized home-based approach study to evaluate the efficacy and safety of alectinib in locally advanced or metastatic ALK-positive solid tumors

    Summary
    EudraCT number
    		 2021-002352-36
    Trial protocol
    		 SE  
    Global end of trial date
    16 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2023
    First version publication date
    13 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BO41929
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04644315
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hoffmann-La Roche
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, 4070
    Public contact
    Medical Communications, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    Medical Communications, F. Hoffmann-La Roche AG, +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
    16 May 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This was a phase II, open‑label, single‑arm decentralized home‑based approach study to evaluate the efficacy and safety of alectinib in locally advanced or metastatic solid tumors (excluding lung cancer) that were determined to be ALK‑positive.
    Protection of trial subjects
    All participants were required to sign an Informed Consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jan 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    0
    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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants at least 18 years of age with ALK-positive locally advanced or metastatic solid tumor (excluding lung cancer) with previously untreated disease or disease progression on prior treatment.

    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
    		 ALK-positive Solid Tumors
    Arm description
    		 Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alectinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BID until disease progression, unacceptable toxicity, death, or withdrawal from study

    Number of subjects in period 1
    		ALK-positive Solid Tumors
    Started
    1
    Completed
    0
    Not completed
    1
         Subject withdrawal of consent
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ALK-positive Solid Tumors
    Reporting group description
    		 Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.

    Reporting group values
    		 ALK-positive Solid Tumors Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1
    Age Continuous
    The risk of participant re-identification is unacceptable for a population of n=1 and this value will therefore not be provided.
    Units: years
        arithmetic mean (standard deviation)
    		 0 ± 0 -
    Sex/Gender, Customized
    The risk of participant re-identification is unacceptable for a population of n=1 and this value will therefore not be provided.
    Units: Participants
        Unreported
    		 1 1
    Race/Ethnicity, Customized
    The risk of participant re-identification is unacceptable for a population of n=1 and this value will therefore not be provided.
    Units: Subjects
        Unreported
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    ALK-positive Solid Tumors
    Reporting group description
    		 Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.

    Primary: Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

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    End point title
    		 Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [1]
    End point description
    End point type
    Primary
    End point timeframe
    From 28 days after initial response up to 5 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: Endpoints were not analyzed as analysis would not be meaningful for one participant.
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [2]
    Units: Percentage
    Notes
    [2] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: Confirmed ORR as Determined by Blinded Independent Center Review (BICR) per RECIST v1.1

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    End point title
    		 Confirmed ORR as Determined by Blinded Independent Center Review (BICR) per RECIST v1.1
    End point description
    End point type
    Secondary
    End point timeframe
    From 28 days after initial response up to 5 years
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [3]
    Units: Percentage
    Notes
    [3] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) as Determined by both the Investigator and by BICR per RECIST v1.1

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    End point title
    		 Duration of Response (DOR) as Determined by both the Investigator and by BICR per RECIST v1.1
    End point description
    End point type
    Secondary
    End point timeframe
    From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [4]
    Units: Time
    Notes
    [4] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) as Determined by both the Investigator and by BICR per RECIST v1.1

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    End point title
    		 Progression-Free Survival (PFS) as Determined by both the Investigator and by BICR per RECIST v1.1
    End point description
    End point type
    Secondary
    End point timeframe
    From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [5]
    Units: Percentage
    Notes
    [5] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: Central Nervous System (CNS) ORR by BICR per RECIST v1.1

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    End point title
    		 Central Nervous System (CNS) ORR by BICR per RECIST v1.1
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to 5 years
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [6]
    Units: Percentage
    Notes
    [6] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: CNS DOR by BICR per RECIST v1.1

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    End point title
    		 CNS DOR by BICR per RECIST v1.1
    End point description
    End point type
    Secondary
    End point timeframe
    From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years)
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [7]
    Units: Time
    Notes
    [7] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug to death from any cause (up to 5 years)
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [8]
    Units: Percentage
    Notes
    [8] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Adverse Events (AEs)

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    End point title
    		 Percentage of Participants with Adverse Events (AEs)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [9]
    Units: Percentage
    Notes
    [9] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants with Serious Adverse Events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [10]
    Units: Percentage
    Notes
    [10] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Alectinib

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    End point title
    		 Plasma Concentration of Alectinib
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to 5 years
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [11]
    Units: ug/mL
    Notes
    [11] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: ORR in Participants with Primary CNS Tumors as Determined by both BICR and the Investigator per Response Assessment in Neuro-Oncology (RANO) Criteria

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    End point title
    		 ORR in Participants with Primary CNS Tumors as Determined by both BICR and the Investigator per Response Assessment in Neuro-Oncology (RANO) Criteria
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [12]
    Units: Percentage
    Notes
    [12] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: DOR in Participants with Primary CNS Tumors as Determined by both BICR and the Investigator per RANO Criteria

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    End point title
    		 DOR in Participants with Primary CNS Tumors as Determined by both BICR and the Investigator per RANO Criteria
    End point description
    End point type
    Secondary
    End point timeframe
    From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [13]
    Units: Time
    Notes
    [13] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: PFS in Participants with Primary CNS Tumors as Determined by both BICR and the Investigator per RANO Criteria

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    End point title
    		 PFS in Participants with Primary CNS Tumors as Determined by both BICR and the Investigator per RANO Criteria
    End point description
    End point type
    Secondary
    End point timeframe
    From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [14]
    Units: Percentage
    Notes
    [14] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Secondary: OS in Participants with Primary CNS Tumors

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    End point title
    		 OS in Participants with Primary CNS Tumors
    End point description
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug to death from any cause (up to 5 years)
    End point values
    		 ALK-positive Solid Tumors
    Number of subjects analysed
    0 [15]
    Units: Percentage
    Notes
    [15] - Endpoint analysis was not meaningful for one participant and was therefore not performed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 5 years
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    ALK-positive Solid Tumors
    Reporting group description
    		 Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.

    Serious adverse events
    		 ALK-positive Solid Tumors
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ALK-positive Solid Tumors
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Weight decreased
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jun 2021
    Allowed enrollment of participants with non-Foundation Medicine next-gen sequencing results; allowed enrollment of participants with carcinoma of unknown primary (CUP) site; changed endpoint of overall response rate (ORR) to confirmed ORR.
    17 Aug 2021
    Incorporated the use of physical study sites; changed overall response rate to objective response rate.

    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.

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