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    Clinical Trial Results:
    Phase II, Open Label, Single Arm Study Assessing the Clinical Benefit of SAR125844, Administered as Single Agent by Weekly Intravenous (IV) Infusion, for the Treatment of Patients With Advanced Pretreated Non-Small Cell Lung Cancer (NSCLC) Harboring MET Gene Amplification

    Summary
    EudraCT number
    2014-005696-93
    Trial protocol
    BE   HU   ES   NL   CZ   GR   FR   AT   PL  
    Global end of trial date
    05 Jan 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Jan 2017
    First version publication date
    05 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACT14205
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02435121
    WHO universal trial number (UTN)
    U1111-1163-1136
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    23 Feb 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jan 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the objective response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 reviewed by an Independent Third Party Review, of SAR125844 in subjects with advanced pretreated NSCLC harboring MET gene amplification.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Nov 2015
    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
    Belgium: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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
    The study was conducted at 1 site in Belgium from 09 November 2015 to 05 January 2016.

    Pre-assignment
    Screening details
    Out of 153 subjects pre-screened, only 1 subject was enrolled and treated in the study. This subject discontinued due to disease progression (DP) and considered as completed (as per protocol).

    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
    SAR125844
    Arm description
    SAR125844 570 mg/m^2 intravenous (IV) infusion over 3 hours once weekly in each cycle (each cycle of 3 weeks) until unacceptable toxicity, DP, or consent withdrawal.
    Arm type
    Experimental

    Investigational medicinal product name
    SAR125844
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    SAR125844 570 mg/m^2 once weekly.

    Number of subjects in period 1
    SAR125844
    Started
    1
    Treated
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SAR125844
    Reporting group description
    SAR125844 570 mg/m^2 intravenous (IV) infusion over 3 hours once weekly in each cycle (each cycle of 3 weeks) until unacceptable toxicity, DP, or consent withdrawal.

    Reporting group values
    SAR125844 Total
    Number of subjects
    1 1
    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)
    1 1
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    1 1
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    SAR125844
    Reporting group description
    SAR125844 570 mg/m^2 intravenous (IV) infusion over 3 hours once weekly in each cycle (each cycle of 3 weeks) until unacceptable toxicity, DP, or consent withdrawal.

    Primary: Percentage of Subjects With Objective Response

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    End point title
    Percentage of Subjects With Objective Response [1]
    End point description
    Objective response rate was defined as the percentage of subjects from the assessed population with complete response (CR) or partial response (PR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. An objective response was confirmed at least 4 weeks after the first documentation of response.
    End point type
    Primary
    End point timeframe
    Baseline up to DP, death or study cut-off, whichever came first (maximum duration: 58 days)
    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: Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    End point values
    SAR125844
    Number of subjects analysed
    0 [2]
    Units: percentage of subjects
        number (confidence interval 95%)
    ( to )
    Notes
    [2] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Secondary: Duration of response (DOR)

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    End point title
    Duration of response (DOR)
    End point description
    DOR was defined as the time (in weeks) from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of DP or death (due to any cause), whichever occurred first. In the absence of DP or death, the DOR should be censored at the date of the last tumor assessment or the cutoff date, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    From the time of the first documented evidence of a confirmed CR or PR until DP, death or study cut-off, whichever came first (maximum duration: 58 days)
    End point values
    SAR125844
    Number of subjects analysed
    0 [3]
    Units: weeks
        median (confidence interval 95%)
    ( to )
    Notes
    [3] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

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    End point title
    Progression-Free Survival (PFS)
    End point description
    PFS was defined as time interval (in months) between the date of the first infusion of SAR125844 to the date of first documentation of tumor progression or death due to any cause, whichever occurs first. In the absence of DP or death, the subject was to be censored at the date of the last tumor assessment or the cut-off date, whichever occurs first. DP was defined using RECIST version 1.1 as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. 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 was also considered progression.
    End point type
    Secondary
    End point timeframe
    Baseline up to DP, death or study cut-off, whichever came first (maximum duration: 58 days)
    End point values
    SAR125844
    Number of subjects analysed
    0 [4]
    Units: months
        median (confidence interval 95%)
    ( to )
    Notes
    [4] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    Overall survival (OS)
    End point description
    OS was defined as the time interval (in months) from the date of first infusion of SAR125844 to the date of death due to any cause. In the absence of death, the subject was to be censored at the last date the subject was known to be alive or the analysis cut-off date if the subject was known to be alive after analysis cut-off date.
    End point type
    Secondary
    End point timeframe
    Baseline up to death or study cut-off date, whichever came first (maximum duration: 58 days)
    End point values
    SAR125844
    Number of subjects analysed
    0 [5]
    Units: months
        median (confidence interval 95%)
    ( to )
    Notes
    [5] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) for SAR125844

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    End point title
    Maximum Observed Plasma Concentration (Cmax) for SAR125844
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 hour, 2.5 to 3 hours, 4 hours and 45 hours after EOI
    End point values
    SAR125844
    Number of subjects analysed
    0 [6]
    Units: mcg/mL
        arithmetic mean (standard deviation)
    ±
    Notes
    [6] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Secondary: Area Under the Concentration-Time Curve (AUC) for SAR125844

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    End point title
    Area Under the Concentration-Time Curve (AUC) for SAR125844
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1: 5 minutes before EOI, 15 minutes, 1 hour, 2.5 to 3 hours, 4 hours and 45 hours after EOI
    End point values
    SAR125844
    Number of subjects analysed
    0 [7]
    Units: mcg*h/mL
        arithmetic mean (standard deviation)
    ±
    Notes
    [7] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Secondary: Clearance (CL) for SAR125844

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    End point title
    Clearance (CL) for SAR125844
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1: 5 minutes before EOI, 15 minutes, 1 hour, 2.5 to 3 hours, 4 hours and 45 hours after EOI
    End point values
    SAR125844
    Number of subjects analysed
    0 [8]
    Units: Litre/hour
        arithmetic mean (standard deviation)
    ±
    Notes
    [8] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Secondary: Volume of Distribution at Steady State (Vss) for SAR125844

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    End point title
    Volume of Distribution at Steady State (Vss) for SAR125844
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1: 5 minutes before EOI, 15 minutes, 1 hour, 2.5 to 3 hours, 4 hours and 45 hours after EOI
    End point values
    SAR125844
    Number of subjects analysed
    0 [9]
    Units: Litre
        arithmetic mean (standard deviation)
    ±
    Notes
    [9] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Observed Plasma Concentration (Tmax) for SAR125844

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    End point title
    Time to Reach Maximum Observed Plasma Concentration (Tmax) for SAR125844
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1: 5 minutes before EOI, 15 minutes, 1 hour, 2.5 to 3 hours, 4 hours and 45 hours after EOI
    End point values
    SAR125844
    Number of subjects analysed
    0 [10]
    Units: Hours
        median (full range (min-max))
    ( to )
    Notes
    [10] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Secondary: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) at Day 1 of Each Cycle and at End of Treatment (EOT)

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    End point title
    Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) at Day 1 of Each Cycle and at End of Treatment (EOT)
    End point description
    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer subjects. It includes five functional scales (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms scales (fatigue, pain, nausea/vomiting) and other single items (dyspnea, appetite loss, constipation, insomnia, diarrhoea and financial difficulties). 28 questions used 4 point scale (1 “Not at all” to 4 “Very much”); 2 questions used 7-point scale (1 “Very poor” to 7 “Excellent”). Scores were averaged and transformed to 0-100 scale; higher scores indicated better level of functioning or greater degree of symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1 of Cycle 1), then Day 1 of each cycle (before SAR125844 administration) and at EOT (30 days after last dose) (maximum duration: 58 days)
    End point values
    SAR125844
    Number of subjects analysed
    0 [11]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    Notes
    [11] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Secondary: Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Score at Day 1 of Each Cycle and at EOT

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    End point title
    Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Score at Day 1 of Each Cycle and at EOT
    End point description
    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Response ranges from 1 “not at all” to 4 “very much”. Scores for each item were transformed to 0 to 100 , where higher symptom score = greater degree of symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1 of Cycle 1), then Day 1 of each cycle (before SAR125844 administration) and at EOT (30 days after last dose) (maximum duration: 58 days)
    End point values
    SAR125844
    Number of subjects analysed
    0 [12]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    Notes
    [12] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score at Day 1 of Cycle 4 and at EOT

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    End point title
    Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score at Day 1 of Cycle 4 and at EOT
    End point description
    CTSQ is a validated 16-item questionnaire that measures three domains related to subject’s satisfaction with cancer therapy. These include expectations of therapy (5 questions), feelings about side effects (4 questions), and satisfaction with therapy (7 questions). All questions were assessed on a 5-point scale; 1=never to 5=always. Scores from all questions were averaged and transformed to provide a total score range of 0-100; where higher scores represent better health.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1 of Cycle 1), then Day 1 of Cycle 4 (before SAR125844 administration) and at EOT (30 days after last dose) (maximum duration: 58 days)
    End point values
    SAR125844
    Number of subjects analysed
    0 [13]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    Notes
    [13] - Endpoint was not analyzed as study terminated prematurely due to unsatisfactory subject recruitment.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (58 days) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs are treatment emergent that is AEs that developed/worsened that occurred during 'the treatment emergent period’ (time from first dose of study drug until 30 days after the last administration of study drug).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    SAR125844
    Reporting group description
    SAR125844 570 mg/m^2 IV infusion over 3 hours once weekly in each cycle (each cycle of 3 weeks) until unacceptable toxicity, DP, or consent withdrawal.

    Serious adverse events
    SAR125844
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    SAR125844
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         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? No

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Nov 2015
    The study was terminated prematurely due to unsatisfactory subject recruitment.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None of the endpoints were analysed as the study was terminated prematurely due to unsatisfactory subject recruitment.
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