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    Clinical Trial Results:
    A Randomized, Open-Label Phase 2 Study of EC145 Single-agent and the Combination of EC145 plus Docetaxel Versus Docetaxel Alone in Participants with Folate-Receptor Positive [FR(++)] Second Line NSCLC

    Summary
    EudraCT number
    2012-000966-40
    Trial protocol
    HU   CZ   ES   GB   BG   DE  
    Global end of trial date
    01 Jun 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Aug 2018
    First version publication date
    23 Aug 2018
    Other versions
    Summary report(s)
    EC-FV-07 CSR (FEB-2017)

    Trial information

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    Trial identification
    Sponsor protocol code
    EC-FV-07
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01577654
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Endocyte, Inc.
    Sponsor organisation address
    3000 Kent Avenue, Suite A1-100, West Lafayette, United States, 47906
    Public contact
    Christopher Jordan, Endocyte, Inc., +1 3176080769, cjordan@endocyte.com
    Scientific contact
    Christopher Jordan, Endocyte, Inc., +1 3176080769, cjordan@endocyte.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
    14 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study tests the activity of single-agent EC145 and the combination of EC145 plus docetaxel against the current standard docetaxel in second line NSCLC in participants with all target lesions expressing the folate receptor [FR(++)]. Primary objective: progression free survival (PFS)
    Protection of trial subjects
    Preparation of the ICF is the responsibility of the investigator and must include all elements required by the International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPAA) or other local regulatory requirements for protection of personal information, and other applicable regulatory requirements and must adhere to the ethical principles that have their origin in the Declaration of Helsinki. The ICF will be approved and reviewed by the sponsor prior to IRB/IEC review.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    20 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Bulgaria: 13
    Country: Number of subjects enrolled
    Czech Republic: 5
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Hungary: 36
    Country: Number of subjects enrolled
    United States: 35
    Country: Number of subjects enrolled
    Romania: 31
    Country: Number of subjects enrolled
    Russian Federation: 29
    Worldwide total number of subjects
    199
    EEA total number of subjects
    135
    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)
    109
    From 65 to 84 years
    90
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A randomized trial was proposed to minimize patient and/or investigator bias. The differences in treatment schedules and anticipated differences in toxicity made an open-label study more pragmatic than a blinded study. The multicenter design of the study provided reassurance that the study population would include a broad variety of patients.

    Pre-assignment
    Screening details
    Medical history, physical examination, and ECOG; Radiographic analysis - target lesions identified within 28 days prior to first dose of study treatment and prior to imaging; Pregnancy test for all women of childbearing age; Hematology, serum chemistry, and urinalysis; Imaging for eligibility determination; Documentation of concomitant medications.

    Pre-assignment period milestones
    Number of subjects started
    336 [1]
    Intermediate milestone: Number of subjects
    Received EC20: 290
    Intermediate milestone: Number of subjects
    Randomized: 203
    Number of subjects completed
    199

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Did not meet inclusion criteria: 133
    Reason: Number of subjects
    Consent withdrawn by subject: 2
    Reason: Number of subjects
    Adverse event, non-fatal: 1
    Reason: Number of subjects
    Physician decision: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The worldwide number enrolled includes only those subjects who completed the trial whereas the pre-assignment period begins with the total number of subjects screened.
    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Open-label study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Experimental: Arm A: EC145 Alone
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    EC145
    Investigational medicinal product code
    Other name
    Vintafolide
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Vintafolide was administered as a 2.5 mg IV bolus injection on Days 1, 4, 8, and 11 during Weeks 1 and 2 of a 3-week cycle.

    Investigational medicinal product name
    EC20
    Investigational medicinal product code
    Other name
    Etarfolatide
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Prior to SPECT imaging, patients received 1 IV injection of 0.5 mg folic acid, 1 to 3 minutes before a 1 to 2 mL IV injection of 0.1 mg etarfolatide labeled with 20 mCi to 25 mCi of 99mTc.

    Arm title
    Experimental: Arm B: EC145 + Docetaxel
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    EC145
    Investigational medicinal product code
    Other name
    Vintafolide
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Vintafolide was administered as a 2.5 mg IV bolus injection on Days 1, 4, 8, and 11 during Weeks 1 and 2 of a 3-week cycle.

    Investigational medicinal product name
    EC20
    Investigational medicinal product code
    Other name
    Etarfolatide
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Prior to SPECT imaging, patients received 1 IV injection of 0.5 mg folic acid, 1 to 3 minutes before a 1 to 2 mL IV injection of 0.1 mg etarfolatide labeled with 20 mCi to 25 mCi of 99mTc.

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel was administered at 75 mg/m2 IV over 1 hour on Day 1 of a 3-week cycle; must have been in conjunction with Day 1 of vintafolide administration for patients in the combination treatment arm. All patients receiving docetaxel were to be pre-medicated with oral dexamethasone according to standard medical practice unless medically contraindicated: 16 mg per day for 3 days starting 1 day prior to docetaxel administration.

    Arm title
    Active Comparator: Arm C: Docetaxel Alone
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel was administered at 75 mg/m2 IV over 1 hour on Day 1 of a 3-week cycle; must have been in conjunction with Day 1 of vintafolide administration for patients in the combination treatment arm. All patients receiving docetaxel were to be pre-medicated with oral dexamethasone according to standard medical practice unless medically contraindicated: 16 mg per day for 3 days starting 1 day prior to docetaxel administration.

    Investigational medicinal product name
    EC20
    Investigational medicinal product code
    Other name
    Etarfolatide
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Prior to SPECT imaging, patients received 1 IV injection of 0.5 mg folic acid, 1 to 3 minutes before a 1 to 2 mL IV injection of 0.1 mg etarfolatide labeled with 20 mCi to 25 mCi of 99mTc.

    Number of subjects in period 1
    Experimental: Arm A: EC145 Alone Experimental: Arm B: EC145 + Docetaxel Active Comparator: Arm C: Docetaxel Alone
    Started
    63
    68
    68
    Completed
    63
    68
    68

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental: Arm A: EC145 Alone
    Reporting group description
    -

    Reporting group title
    Experimental: Arm B: EC145 + Docetaxel
    Reporting group description
    -

    Reporting group title
    Active Comparator: Arm C: Docetaxel Alone
    Reporting group description
    -

    Reporting group values
    Experimental: Arm A: EC145 Alone Experimental: Arm B: EC145 + Docetaxel Active Comparator: Arm C: Docetaxel Alone Total
    Number of subjects
    63 68 68 199
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    32 36 41 109
        From 65-84 years
    31 32 27 90
        85 years and over
    0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    18 21 16 55
        Male
    45 47 52 144
    Race
    Units: Subjects
        Asian
    0 1 2 3
        Black/African American
    0 1 1 2
        White
    60 65 63 188
        Missing
    3 1 2 6
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    1 0 0 1
        Not Hispanic or Latino
    59 67 66 192
        Missing
    3 1 2 6
    ECOG performance status
    Units: Subjects
        00
    14 18 18 50
        01
    48 50 50 148
        02
    1 0 0 1
    Smoking Status
    Units: Subjects
        Never smoked
    15 7 10 32
        Formerly smoked
    29 43 37 109
        Currently smoke
    19 18 21 58
    Type of Cancer
    Units: Subjects
        Adenocarcinoma
    37 39 43 119
        Adenosquamous carcinoma
    2 2 5 9
        Adenocarcinoma with other NSCLC variants
    2 2 1 5
        Squamous cell carcinoma
    22 25 19 66
    Time since last chemotherapy
    Units: Subjects
        <3 months
    31 33 34 98
        >3 months
    32 35 34 101
    Best response to last chemotherapy
    Units: Subjects
        CR/PR/SD
    46 49 48 143
        PD/Unknown
    17 19 20 56
    Disease stage
    Units: Subjects
        Stage IIIB
    12 10 9 31
        Stage IV
    51 58 59 168
    Prior treatment with EGFR inhibitor
    Units: Subjects
        Yes
    11 10 9 30
        No
    52 58 59 169

    End points

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    End points reporting groups
    Reporting group title
    Experimental: Arm A: EC145 Alone
    Reporting group description
    -

    Reporting group title
    Experimental: Arm B: EC145 + Docetaxel
    Reporting group description
    -

    Reporting group title
    Active Comparator: Arm C: Docetaxel Alone
    Reporting group description
    -

    Subject analysis set title
    Efficacy Analysis Population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The efficacy analysis population consisted of all randomized patients who received 1 or more doses of vintafolide and/or docetaxel, by planned treatment.

    Subject analysis set title
    Safety Analysis Population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety analysis population consisted of all randomized patients who received at least 1 dose of vintafolide and/or docetaxel, by actual treatment.

    Primary: PFS

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    End point title
    PFS
    End point description
    End point type
    Primary
    End point timeframe
    31 May 2012 - 14 February 2014
    End point values
    Experimental: Arm A: EC145 Alone Experimental: Arm B: EC145 + Docetaxel Active Comparator: Arm C: Docetaxel Alone
    Number of subjects analysed
    63
    68
    68
    Units: Months
        median (confidence interval 95%)
    1.6 (1.4 to 3.2)
    4.2 (2.8 to 5.4)
    3.3 (1.7 to 4.2)
    Statistical analysis title
    Efficacy Analysis
    Comparison groups
    Experimental: Arm B: EC145 + Docetaxel v Active Comparator: Arm C: Docetaxel Alone v Experimental: Arm A: EC145 Alone
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.1
    Method
    Logrank
    Confidence interval

    Secondary: Overall Response Rate

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    End point title
    Overall Response Rate
    End point description
    End point type
    Secondary
    End point timeframe
    31 May 2012 - 14 February 2014
    End point values
    Experimental: Arm A: EC145 Alone Experimental: Arm B: EC145 + Docetaxel Active Comparator: Arm C: Docetaxel Alone
    Number of subjects analysed
    63
    68
    68
    Units: ORR
    4
    15
    9
    No statistical analyses for this end point

    Secondary: Disease Control Rate

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    End point title
    Disease Control Rate
    End point description
    End point type
    Secondary
    End point timeframe
    31 May 2012 - 14 February 2014
    End point values
    Experimental: Arm A: EC145 Alone Experimental: Arm B: EC145 + Docetaxel Active Comparator: Arm C: Docetaxel Alone
    Number of subjects analysed
    63
    68
    68
    Units: DCR
    26
    48
    41
    No statistical analyses for this end point

    Secondary: Duration of Disease Controls

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    End point title
    Duration of Disease Controls
    End point description
    End point type
    Secondary
    End point timeframe
    31 May 2012 - 14 February 2014
    End point values
    Experimental: Arm A: EC145 Alone Experimental: Arm B: EC145 + Docetaxel Active Comparator: Arm C: Docetaxel Alone
    Number of subjects analysed
    63
    68
    68
    Units: Months
        median (confidence interval 95%)
    4.3 (3.2 to 5.1)
    5.4 (4.2 to 6.1)
    5.5 (4.1 to 6.8)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    Overall Survival
    End point description
    End point type
    Secondary
    End point timeframe
    31 May 2012 - 14 February 2014
    End point values
    Experimental: Arm A: EC145 Alone Experimental: Arm B: EC145 + Docetaxel Active Comparator: Arm C: Docetaxel Alone
    Number of subjects analysed
    63
    68
    68
    Units: Months
        median (confidence interval 95%)
    8.4 (5.6 to 12.3)
    11.5 (7.3 to 12.9)
    8.8 (5.4 to 12.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    31 May 2012-14 February 2014
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Experimental: Arm A: EC145 Alone
    Reporting group description
    -

    Reporting group title
    Experimental: Arm B: EC145 + Docetaxel
    Reporting group description
    -

    Reporting group title
    Active Comparator: Arm C: Docetaxel Alone
    Reporting group description
    -

    Serious adverse events
    Experimental: Arm A: EC145 Alone Experimental: Arm B: EC145 + Docetaxel Active Comparator: Arm C: Docetaxel Alone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 63 (22.22%)
    29 / 68 (42.65%)
    24 / 68 (35.29%)
         number of deaths (all causes)
    31
    27
    34
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 68 (2.94%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Circulatory collapse
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    1 / 34
    Embolism
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    1 / 27
    0 / 34
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    1 / 27
    0 / 34
    Cardiac failure acute
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    1 / 27
    0 / 34
    Cardiac failure congestive
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    1 / 34
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    3 / 63 (4.76%)
    2 / 68 (2.94%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    3 / 31
    0 / 27
    1 / 34
    Pleural effusion
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Pulmonary embolism
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 68 (2.94%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Acute lung injury
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    1 / 34
    Aspiration
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    1 / 27
    0 / 34
    Respiratory arrest
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 31
    0 / 27
    0 / 34
    Respiratory distress
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    1 / 34
    Respiratory failure
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    1 / 27
    0 / 34
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 63 (0.00%)
    8 / 68 (11.76%)
    4 / 68 (5.88%)
         occurrences causally related to treatment / all
    0 / 12
    8 / 12
    4 / 12
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Neutropenia
         subjects affected / exposed
    0 / 63 (0.00%)
    8 / 68 (11.76%)
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    0 / 11
    8 / 11
    3 / 11
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Anaemia
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    2 / 4
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Nervous system disorders
    Brain compression
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    1 / 27
    0 / 34
    Hemiparesis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    1 / 34
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 68 (2.94%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    1 / 34
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 68 (5.88%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 5
    4 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 63 (0.00%)
    3 / 68 (4.41%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 4
    1 / 4
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 68 (5.88%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    1 / 34
    Neutropenic sepsis
         subjects affected / exposed
    0 / 63 (0.00%)
    3 / 68 (4.41%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    3 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 31
    1 / 27
    0 / 34
    Sepsis
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 68 (2.94%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    0 / 34
    Pneumonia bacterial
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 31
    0 / 27
    1 / 34
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Experimental: Arm A: EC145 Alone Experimental: Arm B: EC145 + Docetaxel Active Comparator: Arm C: Docetaxel Alone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 63 (85.71%)
    67 / 68 (98.53%)
    65 / 68 (95.59%)
    Investigations
    Weight decreased
         subjects affected / exposed
    2 / 63 (3.17%)
    7 / 68 (10.29%)
    6 / 68 (8.82%)
         occurrences all number
    15
    15
    15
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 63 (1.59%)
    4 / 68 (5.88%)
    2 / 68 (2.94%)
         occurrences all number
    7
    7
    7
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    7 / 63 (11.11%)
    7 / 68 (10.29%)
    11 / 68 (16.18%)
         occurrences all number
    25
    25
    25
    Cough
         subjects affected / exposed
    3 / 63 (4.76%)
    5 / 68 (7.35%)
    5 / 68 (7.35%)
         occurrences all number
    13
    13
    13
    Haemoptysis
         subjects affected / exposed
    6 / 63 (9.52%)
    3 / 68 (4.41%)
    3 / 68 (4.41%)
         occurrences all number
    12
    12
    12
    Hypoxia
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 68 (5.88%)
    0 / 68 (0.00%)
         occurrences all number
    4
    4
    4
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    2 / 63 (3.17%)
    50 / 68 (73.53%)
    40 / 68 (58.82%)
         occurrences all number
    92
    92
    92
    Anaemia
         subjects affected / exposed
    15 / 63 (23.81%)
    14 / 68 (20.59%)
    20 / 68 (29.41%)
         occurrences all number
    49
    49
    49
    Leukopenia
         subjects affected / exposed
    1 / 63 (1.59%)
    17 / 68 (25.00%)
    21 / 68 (30.88%)
         occurrences all number
    39
    39
    39
    Febrile Neutropenia
         subjects affected / exposed
    0 / 63 (0.00%)
    9 / 68 (13.24%)
    4 / 68 (5.88%)
         occurrences all number
    13
    13
    13
    Thrombocytopenia
         subjects affected / exposed
    0 / 63 (0.00%)
    5 / 68 (7.35%)
    3 / 68 (4.41%)
         occurrences all number
    8
    8
    8
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    10 / 63 (15.87%)
    20 / 68 (29.41%)
    13 / 68 (19.12%)
         occurrences all number
    43
    43
    43
    Headache
         subjects affected / exposed
    4 / 63 (6.35%)
    3 / 68 (4.41%)
    5 / 68 (7.35%)
         occurrences all number
    12
    12
    12
    Dizziness
         subjects affected / exposed
    2 / 63 (3.17%)
    5 / 68 (7.35%)
    3 / 68 (4.41%)
         occurrences all number
    10
    10
    10
    Dysgeusia
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    5 / 68 (7.35%)
         occurrences all number
    6
    6
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 63 (14.29%)
    18 / 68 (26.47%)
    23 / 68 (33.82%)
         occurrences all number
    50
    50
    50
    Asthenia
         subjects affected / exposed
    10 / 63 (15.87%)
    17 / 68 (25.00%)
    9 / 68 (13.24%)
         occurrences all number
    36
    36
    36
    Pyrexia
         subjects affected / exposed
    0 / 63 (0.00%)
    11 / 68 (16.18%)
    7 / 68 (10.29%)
         occurrences all number
    18
    18
    18
    Chest pain
         subjects affected / exposed
    3 / 63 (4.76%)
    6 / 68 (8.82%)
    1 / 68 (1.47%)
         occurrences all number
    10
    10
    10
    Oedema peripheral
         subjects affected / exposed
    2 / 63 (3.17%)
    5 / 68 (7.35%)
    2 / 68 (2.94%)
         occurrences all number
    9
    9
    9
    Chills
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 68 (5.88%)
    1 / 68 (1.47%)
         occurrences all number
    5
    5
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 63 (3.17%)
    16 / 68 (23.53%)
    16 / 68 (23.53%)
         occurrences all number
    34
    34
    34
    Nausea
         subjects affected / exposed
    3 / 63 (4.76%)
    10 / 68 (14.71%)
    13 / 68 (19.12%)
         occurrences all number
    26
    26
    26
    Stomatitis
         subjects affected / exposed
    2 / 63 (3.17%)
    13 / 68 (19.12%)
    11 / 68 (16.18%)
         occurrences all number
    26
    26
    26
    Constipation
         subjects affected / exposed
    10 / 63 (15.87%)
    6 / 68 (8.82%)
    5 / 68 (7.35%)
         occurrences all number
    21
    21
    21
    Vomiting
         subjects affected / exposed
    3 / 63 (4.76%)
    9 / 68 (13.24%)
    8 / 68 (11.76%)
         occurrences all number
    20
    20
    20
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 63 (0.00%)
    11 / 68 (16.18%)
    13 / 68 (19.12%)
         occurrences all number
    24
    24
    24
    Rash
         subjects affected / exposed
    0 / 63 (0.00%)
    6 / 68 (8.82%)
    3 / 68 (4.41%)
         occurrences all number
    9
    9
    9
    Dry skin
         subjects affected / exposed
    1 / 63 (1.59%)
    4 / 68 (5.88%)
    0 / 68 (0.00%)
         occurrences all number
    5
    5
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 63 (7.94%)
    8 / 68 (11.76%)
    10 / 68 (14.71%)
         occurrences all number
    23
    23
    23
    Myalgia
         subjects affected / exposed
    3 / 63 (4.76%)
    8 / 68 (11.76%)
    7 / 68 (10.29%)
         occurrences all number
    18
    18
    18
    Back pain
         subjects affected / exposed
    0 / 63 (0.00%)
    5 / 68 (7.35%)
    7 / 68 (10.29%)
         occurrences all number
    12
    12
    12
    Pain in extremity
         subjects affected / exposed
    2 / 63 (3.17%)
    5 / 68 (7.35%)
    4 / 68 (5.88%)
         occurrences all number
    11
    11
    11
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 63 (14.29%)
    14 / 68 (20.59%)
    11 / 68 (16.18%)
         occurrences all number
    34
    34
    34
    Dehydration
         subjects affected / exposed
    1 / 63 (1.59%)
    6 / 68 (8.82%)
    4 / 68 (5.88%)
         occurrences all number
    11
    11
    11
    Hypokalaemia
         subjects affected / exposed
    1 / 63 (1.59%)
    8 / 68 (11.76%)
    1 / 68 (1.47%)
         occurrences all number
    10
    10
    10
    Hyponatraemia
         subjects affected / exposed
    0 / 63 (0.00%)
    8 / 68 (11.76%)
    2 / 68 (2.94%)
         occurrences all number
    10
    10
    10
    Hyperglycaemia
         subjects affected / exposed
    0 / 63 (0.00%)
    5 / 68 (7.35%)
    4 / 68 (5.88%)
         occurrences all number
    9
    9
    9
    Hypomagnesaemia
         subjects affected / exposed
    0 / 63 (0.00%)
    6 / 68 (8.82%)
    1 / 68 (1.47%)
         occurrences all number
    7
    7
    7
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 68 (5.88%)
    2 / 68 (2.94%)
         occurrences all number
    6
    6
    6
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 68 (5.88%)
    2 / 68 (2.94%)
         occurrences all number
    6
    6
    6
    Oral candidiasis
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 68 (5.88%)
    0 / 68 (0.00%)
         occurrences all number
    4
    4
    4
    Respiratory tract infection
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 68 (5.88%)
    0 / 68 (0.00%)
         occurrences all number
    4
    4
    4

    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? 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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