Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer who failed first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor

    Summary
    EudraCT number
    		 2012-001896-35
    Trial protocol
    		 BE   HU   IE   AT   ES   NL   DE   IT   DK   GB   GR  
    Global end of trial date
    31 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Feb 2020
    First version publication date
    07 Feb 2020
    Other versions
    Summary report(s)
    		 Publibation_Peters et al_J Thorac Oncol_2017_DOI: 10.1016/j.jtho.2016.12.017

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ETOP3-12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01652469
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    European Thoracic Oncology Platform (ETOP)
    Sponsor organisation address
    Effingerstrasse 40, Bern, Switzerland, 3008
    Public contact
    ETOP Coordinating Office, ETOP , +41 31 511 94 00, emphasis@etop-eu.org
    Scientific contact
    ETOP Coordinating Office, ETOP , +41 31 511 94 00, emphasis@etop-eu.org
    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
    31 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Explore the predictive ability of VeriStrat signature, by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (Good vs Poor) using progression free survival as outcome.
    Protection of trial subjects
    Trial subjects are closely monitored during the entire duration of the trial by the participating investigators. For safety purposes any adverse events occurred from enrolment of a trial subject until 30 days after treatment discontinuation need to be reported. In case of adverse events and treatment-related toxicities management guidance have been provided in the study protocol to treat trial subjects in adequately manner. Precautions and warnings about the use of the study drug are provided in the trial subject information sheet to ensure that study drug is correctly used in order to avoid unnecessary adverse reactions and in addition to ensure that in case of an adverse event the study patient contacts the investigator for appropriate measures. The safety and efficacy of the trial treatment have been regularly reviewed by the ETOP IDMC (independent data monitoring committee) at their semi-annual meetings to safeguard the interest and safety of the patients in the trial and to ensure the scientific integrity of the trial. Additionally, the risk/benefit ratio have been regularly evaluated by the ETOP Steering Committee on a semi-annual basis. Technical and organisational controls (including physical, electronic and managerial measures) are in place to protect personal data and integrity of trial subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Sep 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
    Netherlands: 13
    Country: Number of subjects enrolled
    Spain: 35
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Ireland: 7
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Switzerland: 14
    Country: Number of subjects enrolled
    Israel: 2
    Worldwide total number of subjects
    80
    EEA total number of subjects
    64
    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)
    27
    From 65 to 84 years
    53
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The first patient was enrolled to the ETOP/3-12 EMPHASIS trial on 14.01.2013. On 31.01.2014 accrual was closed due to a low accrual rate (81 patients enrolled). As of 31.12.2018 follow-up was ended.

    Pre-assignment
    Screening details
    		 One patient, who shouldn't have been included (exclusion criteria), was enrolled in the database by mistake. In the database patient's status couldn't be changed from "Enrolled" to "Ineligible", thus this patient was considered enrolled, but was not included in the efficacy cohort.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Erlotinib
    Arm description
    		 Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tarceva
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Erlotinib is started at a fixed oral dose of 150 mg per day. Tablets should be taken at a fixed time each day and at least 1 hour before, or 2 hours after the ingestion of food. No routine premedication (e.g. to prevent skin toxicity) is recommended for erlotinib. Systemic or local tetracyclines, systemic or local corticosteroids and loperamide in case of diarrhea are strongly recommended if significant toxicity occurs. Smokers have reduced plasma levels and should be counseled for smoking reduction or cessation, the dose of 150 mg must never be increased. In case of relevant toxicity, dose reductions are recommended to improve the tolerance.

    Arm title
    		 Docetaxel
    Arm description
    		 Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Taxotere
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients should be premedicated with oral corticosteroids such as dexamethasone 16 mg per day (e.g., 8 mg BID) for 3 days starting 1 day prior to docetaxel administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. In case of relevant toxicity, dose reductions are recommended to improve the tolerance.

    Number of subjects in period 1
    		Erlotinib Docetaxel
    Started
    38
    42
    Completed
    37
    36
    Not completed
    1
    6
         Withdrawal by Subject
    1
    4
         Lost to follow-up
    -
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Erlotinib
    Reporting group description
    		 Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.

    Reporting group title
    Docetaxel
    Reporting group description
    		 Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.

    Reporting group values
    		 Erlotinib Docetaxel Total
    Number of subjects
    		 38 42 80
    Age categorical
    Age as continuous characteristic only
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    		 66.7 (44.4 to 81.9) 70.1 (53.3 to 84.0) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7 14
        Male
    		 31 35 66
    Smoking history
    Units: Subjects
        Current
    		 16 12 28
        Former (>100 cigarettes & >12 months smoke-free)
    		 20 28 48
        Never
    		 2 2 4
    ECOG performance status
    PS 0:Fully active, able to carry on all pre-disease performance without restriction. PS 1:Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. PS 2:Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. PS 3:Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. PS 4:Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
    Units: Subjects
        PS 0
    		 12 15 27
        PS 1
    		 24 22 46
        PS 2
    		 2 5 7
    VeriStrat status
    Units: Subjects
        Good
    		 28 30 58
        Poor
    		 10 12 22

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Erlotinib
    Reporting group description
    		 Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.

    Reporting group title
    Docetaxel
    Reporting group description
    		 Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.

    Primary: Progression-free Survival

    		 Close Top of page
    End point title
    		 Progression-free Survival
    End point description
    Time from the date of randomization until documented progression or death without documented progression. Assessment of Progressive Disease (PD) based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Target lesions:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Non-target lesions:Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression). To achieve 'unequivocal progression', there must be an overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently.
    End point type
    Primary
    End point timeframe
    The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months.
    End point values
    		 Erlotinib Docetaxel
    Number of subjects analysed
    38
    42
    Units: months
        median (confidence interval 95%)
    1.6 (1.3 to 3.8)
    3.0 (1.9 to 4.2)
    Statistical analysis title
    		 PFS by treatment, stratified by VeriStrat status
    Comparison groups
    Erlotinib v Docetaxel
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.32
    Method
    		 Stratified Logrank by Veristrat status
    Confidence interval
    Notes
    [1] - Explore differential activity of treatment effect on PFS in the two VeriStrat groups by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (Good vs Poor).

    Secondary: Overall Survival

    		 Close Top of page
    End point title
    		 Overall Survival
    End point description
    Defined as time from the date of randomization until death from any cause.
    End point type
    Secondary
    End point timeframe
    All patients will be followed for survival status every 12 weeks up to 24 months after the last patient is randomized.
    End point values
    		 Erlotinib Docetaxel
    Number of subjects analysed
    38
    42
    Units: months
        median (confidence interval 95%)
    7.1 (4.4 to 10.6)
    7.1 (5.3 to 8.6)
    No statistical analyses for this end point

    Secondary: Objective Response

    		 Close Top of page
    End point title
    		 Objective Response
    End point description
    Objective response is defined as best overall response (CR or PR) across all assessment time-points according to RECIST Criteria 1.1 during the period from randomization to termination of trial treatment.
    End point type
    Secondary
    End point timeframe
    Same as primary outcome: 24 months.
    End point values
    		 Erlotinib Docetaxel
    Number of subjects analysed
    38
    42
    Units: paticipants
        Partial Response
    4
    6
        Stable Disease
    15
    18
        Progressive Disease
    17
    14
        Non-Evaluable
    2
    4
    No statistical analyses for this end point

    Secondary: Disease Control

    		 Close Top of page
    End point title
    		 Disease Control
    End point description
    Disease control is defined as achieving objective response or stable disease for at least 6 weeks.
    End point type
    Secondary
    End point timeframe
    Same as primary outcome: 24 months.
    End point values
    		 Erlotinib Docetaxel
    Number of subjects analysed
    38
    42
    Units: participants
        Disease Control
    19
    24
        No Disease Control
    19
    18
    No statistical analyses for this end point

    Secondary: Toxicities of treatment

    		 Close Top of page
    End point title
    		 Toxicities of treatment
    End point description
    Adverse events classified according to NCI CTCAE version 4.
    End point type
    Secondary
    End point timeframe
    Same as primary outcome: 24 months.
    End point values
    		 Erlotinib Docetaxel
    Number of subjects analysed
    38
    41 [2]
    Units: paticipants
        Experienced AE/SAE
    36
    39
        No AE/SAE
    2
    2
        Experienced SAE
    7
    19
    Notes
    [2] - One patient never started treatment.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study medication (Erlotinib or Docetaxel) until 30 days after the final dose, regardless of whether it is considered related to a medication.
    Adverse event reporting additional description
    One patient from the Docetaxel arm never started treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Erlotinib
    Reporting group description
    		 Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.

    Reporting group title
    Docetaxel
    Reporting group description
    		 Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.

    Serious adverse events
    		 Erlotinib Docetaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 38 (18.42%)
    19 / 41 (46.34%)
         number of deaths (all causes)
    29
    29
         number of deaths resulting from adverse events
    7
    3
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 38 (0.00%)
    6 / 41 (14.63%)
         occurrences causally related to treatment / all
    0 / 0
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death NOS
         subjects affected / exposed
    3 / 38 (7.89%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Fatigue
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jejunal perforation
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary hemorrhage
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Dyspnea
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Respiratory failure
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apnea
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Other
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lung infection
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial infection
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Other
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Erlotinib Docetaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 38 (94.74%)
    39 / 41 (95.12%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor pain
         subjects affected / exposed
    3 / 38 (7.89%)
    0 / 41 (0.00%)
         occurrences all number
    3
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 38 (2.63%)
    4 / 41 (9.76%)
         occurrences all number
    1
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    11 / 38 (28.95%)
    24 / 41 (58.54%)
         occurrences all number
    11
    24
    Pain
         subjects affected / exposed
    4 / 38 (10.53%)
    7 / 41 (17.07%)
         occurrences all number
    4
    7
    Fever
         subjects affected / exposed
    4 / 38 (10.53%)
    3 / 41 (7.32%)
         occurrences all number
    4
    3
    Edema limbs
         subjects affected / exposed
    1 / 38 (2.63%)
    4 / 41 (9.76%)
         occurrences all number
    1
    4
    Flu-like symptoms
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 41 (7.32%)
         occurrences all number
    2
    3
    Death NOS
         subjects affected / exposed
    3 / 38 (7.89%)
    0 / 41 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    16 / 38 (42.11%)
    13 / 41 (31.71%)
         occurrences all number
    16
    13
    Cough
         subjects affected / exposed
    10 / 38 (26.32%)
    14 / 41 (34.15%)
         occurrences all number
    10
    14
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    2 / 38 (5.26%)
    12 / 41 (29.27%)
         occurrences all number
    2
    12
    Aspartate aminotransferase increase
         subjects affected / exposed
    3 / 38 (7.89%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Creatinine increase
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 38 (7.89%)
    4 / 41 (9.76%)
         occurrences all number
    3
    4
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 38 (0.00%)
    4 / 41 (9.76%)
         occurrences all number
    0
    4
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 41 (4.88%)
         occurrences all number
    2
    2
    Eye disorders
    Conjuctivitis
         subjects affected / exposed
    3 / 38 (7.89%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    10 / 38 (26.32%)
    11 / 41 (26.83%)
         occurrences all number
    10
    11
    Mucositis oral
         subjects affected / exposed
    5 / 38 (13.16%)
    9 / 41 (21.95%)
         occurrences all number
    5
    9
    Nausea
         subjects affected / exposed
    4 / 38 (10.53%)
    10 / 41 (24.39%)
         occurrences all number
    4
    10
    Vomiting
         subjects affected / exposed
    3 / 38 (7.89%)
    3 / 41 (7.32%)
         occurrences all number
    3
    3
    Abdominal pain
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    Constipation
         subjects affected / exposed
    1 / 38 (2.63%)
    3 / 41 (7.32%)
         occurrences all number
    1
    3
    Dysphagia
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 41 (4.88%)
         occurrences all number
    1
    2
    Other
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    Oral dysesthesia
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    27 / 38 (71.05%)
    1 / 41 (2.44%)
         occurrences all number
    27
    1
    Alopecia
         subjects affected / exposed
    1 / 38 (2.63%)
    11 / 41 (26.83%)
         occurrences all number
    1
    11
    Dry skin
         subjects affected / exposed
    8 / 38 (21.05%)
    1 / 41 (2.44%)
         occurrences all number
    8
    1
    Nail discoloration
         subjects affected / exposed
    0 / 38 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    Infections and infestations
    Lung infection
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 41 (4.88%)
         occurrences all number
    2
    2
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    7 / 38 (18.42%)
    8 / 41 (19.51%)
         occurrences all number
    7
    8

    More information

    		 Close Top of page

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

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

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

    European Medicines Agency © 1995-Wed Apr 24 19:09:44 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA