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    Clinical Trial Results:
    An Phase II trial aiming to evaluate the clinical interest of ABEMACICLIB monotherapy in patients with locally advanced/metastatic head and neck cancer after failure of platinum and cetuximab or anti-EGFR-based therapy and harboring an homozygous deletion of CDKN2A, and/or an amplification of CCND1 and/or of CDK6

    Summary
    EudraCT number
    		 2016-004537-25
    Trial protocol
    		 FR  
    Global end of trial date
    15 Apr 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Oct 2025
    First version publication date
    30 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ET16-116
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Léon Bérard
    Sponsor organisation address
    28 Rue Laënnec, Lyon, France,
    Public contact
    DRCI - Phases précoces, CENTRE LEON BERARD, 33 (0)426556824, gwenaelle.garin@lyon.unicancer.fr
    Scientific contact
    DRCI - Phases précoces, CENTRE LEON BERARD, 33 (0)426556824, gwenaelle.garin@lyon.unicancer.fr
    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
    20 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Apr 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the clinical activity of ABEMACICLIB as measured by the 8-week non-progression rate (Complete response [CR] + Partial Response [PR] + Stable disease [SD] after 8 weeks of treatment according to RECIST v1.1) in adult patients with locally advanced or metastatic head and neck cancer progressive under platin and cetuximab or anti-EGFR-based chemotherapy.
    Protection of trial subjects
    Study treatments will continue to be administrated as long as patient experiences evidence clinical benefit in the opinion of the investigator, or experiences an unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. The investigator will have to inform the patient of the study treatment, the objectives and the design of the study, as well as the biological samples collection, provide the patient information leaflet / Informed consent form, answer to any questions that the patient may have and ensure that she understands the potential risks and benefits of participating in the study before signing the informed consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Feb 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 66 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    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)
    26
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited at the time of enrolment at the participating sites. The declared investigator, after having identified a potential candidate for the study, informed her orally of the terms of the study and provide her with : an information note, An informed consent form that has been dated and signed by the patient and the investigator.

    Pre-assignment
    Screening details
    		 None study-related procedure can be started before ICF was signed and dated by both the patient (and impartial witness, if applicable) and the investigator - Checked the eligibility criteria list and perform the exams. The screening period is divided into 2 stages: Molecular pre-screening and clinical screening

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

    Arms
    Arm title
    		 ABEMACICLIB
    Arm description
    		 The molecular pre-screening step will allow to defined HPV tumor status as well as molecular status CDKN2A CCND1 CDK6 and CDK4. Following this centralized molecular screening, only patients with HPV negative status and with tumor harboring CDKN2A homozygous deletion and/or CCND1 amplification and/or CDK6 and/or CDK4 amplification could initiate abemaciclib at time of documented radiological progressionPatients will be treated with ABEMACICLIB, 200 mg QH12/day with 2 doses of 200 mg 12-hour apart (QH12). A cycle is defined as an interval of 28 days. For each 28-day cycle, a total of 56 doses of study drug will be dispensed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abemaciclib
    Investigational medicinal product code
    LY2835219
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will receive Abemaciclib 400 mg, daily (200 mg in the morning, 200 mg in the evening) per os. A cycle is defined as an interval of xx days.

    Number of subjects in period 1
    		ABEMACICLIB
    Started
    26
    Completed
    26

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study period
    Reporting group description
    		 -

    Reporting group values
    		 Overall study period Total
    Number of subjects
    		 26 26
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 26 26
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 59.0 (42.0 to 78.0) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 23 23

    End points

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    End points reporting groups
    Reporting group title
    ABEMACICLIB
    Reporting group description
    		 The molecular pre-screening step will allow to defined HPV tumor status as well as molecular status CDKN2A CCND1 CDK6 and CDK4. Following this centralized molecular screening, only patients with HPV negative status and with tumor harboring CDKN2A homozygous deletion and/or CCND1 amplification and/or CDK6 and/or CDK4 amplification could initiate abemaciclib at time of documented radiological progressionPatients will be treated with ABEMACICLIB, 200 mg QH12/day with 2 doses of 200 mg 12-hour apart (QH12). A cycle is defined as an interval of 28 days. For each 28-day cycle, a total of 56 doses of study drug will be dispensed.

    Primary: Primary End Point

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    End point title
    		 Primary End Point [1]
    End point description
    End point type
    Primary
    End point timeframe
    The primary endpoint is the progression-free rate (CR, PR, SD as per RECIST 1.1) after 8 weeks of treatment (PFR8w), assessed by central review.
    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: The non-progression rate will be analyzed using central read tumor assessments and summarized by a proportion together with its 95% confidence interval. At the time of analysis, if at least 7 successes are observed among the 23 evaluable patients, the treatment will be considered as interesting for further investigation in this indication. With alpha 0.05 and 85% power, 23 patients are needed to test H0​:p≤p0​vs��1:��≥��1H1​:p≥p1 in a one-sided test.​
    End point values
    		 ABEMACICLIB
    Number of subjects analysed
    24 [2]
    Units: Patients
        Patients in failure
    17
        Patients in success
    7
    Notes
    [2] - Among the 26 treated patients, 2 patients were considered non-evaluable for primary endpoint
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The investigator collects (spontaneous patient report or questionning) and immediately notifies the sponsor of all SAEs, in a written report, wether or not theay are deemed to be attributable to research and wich occur during the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: At the time of the analysis, 22 patients (84.6%) had presented at least one treatment-related AE and 11 patients (42.3%) had presented at least one grade ≥3 treatment-related AE according to NCI-CTCAE V5.0; 13 patients (50%) had presented AEs leading to dose reduction or temporary discontinuation of treatment and 5 patients (19.2%) had presented AEs leading to treatment permanent discontinuation. Most common treatment-related AEs : anemia 26.9%, diarrhea 53.8%, vomiting 34.6%, fatigue 46.2%.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Feb 2018
    New edition of the abemaciclib Investigator Brochure (ed. 09/15/2017) impacting participant safety, SRIs, and the protocol (without impacting the study's benefit/risk balance). Clarification of an inclusion criterion (I4). Addition of a non-inclusion criterion. Updated the list of investigators.
    31 May 2018
    Modification of an inclusion criterion (I12)
    16 Oct 2018
    Changes to the study’s planned schedule : Total study duration: initially 24 months, extended by 18 months Inclusion period: initially 12 months, extended by 18 months Treatment and follow-up period: unchanged
    16 Apr 2019
    Update of study documents following the General Data Protection Regulation (GDPR); Update of the list of investigators (Declaration of 5 investigators in a research location already declared + Declaration of a new research location)
    07 Jan 2020
    Updated and added recommendations for the management of the following adverse events (AEs) in patients receiving abemaciclib: - Grade 3 increased blood alanine aminotransferase associated with increased bilirubin, - Pneumonitis/interstitial lung disease. Updated AEs related to abemaciclib (addition of a new expected AE: interstitial lung disease/pneumonia). Updated recommendations for concomitant medications to be administered with caution in patients receiving abemaciclib.
    01 Apr 2020
    Update of the Investigator Brochure (IB) for abemaciclib, the substantial modifications of which (recommendations for the management of elevated transaminases, etc.) have been integrated into the protocol (V8.1 of 12/31/2019) of amendment 5-MSA3, following the intermediate letter from the ANSM of December 13, 2019.
    07 Jul 2020
    Changes related to the pandemic (Covid-19): patient monitoring and dispensing procedures for abemacicib in patients with controlled disease after 6 months of treatment and no major safety issues. In addition, the procedure for reporting any Covid-19 diagnosis, documented via a specific form, is specified. Changes to the provisional study schedule : Total study duration: previous version 42 months, 24-month extension Inclusion period: previous version 12 months, 24-month extension Treatment and follow-up period: unchanged
    12 May 2021
    Updated three eligibility criteria in line with the new recommendations issued by Lilly in January 2021; Updated recommendations to be followed by investigators in line with the new edition of the abemaciclib BI and the new recommendations issued by Lilly in January 2021 in the event of adverse events; Clarified concomitant treatments to be administered with caution.

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

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

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