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    Clinical Trial Results:
    Randomized phase II trial of erlotinib (TARCEVA®) or intermittent administration of erlotinib and docetaxel as second-line after chemotherapy failure in male ex-smokers with locally advanced or metastatic non-small cell lung cancer (NSCLC)

    Summary
    EudraCT number
    		 2010-020229-42
    Trial protocol
    		 IT  
    Global end of trial date
    29 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Apr 2016
    First version publication date
    23 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ML21869
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01204697
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 61 6878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of erlotinib and erlotinib combined with docetaxel in ex-smoker participants with squamous NSCLC by using progression-free rate (PFR) at 6 months as primary endpoint.
    Protection of trial subjects
    The study was conducted under the provisions of the Declaration of Helsinki, and in accordance with the International Conference on Harmonization (ICH) Consolidated Guideline on Good Clinical Practice (GCP). The study protocol, protocol amendment, patient information leaflet and informed consent documents were submitted to the Independent Ethics Committee (IEC) of each center participating in the study prior to any study-related procedure was started. The study protocol was approved by the local IEC of each center participating in the study. Prior to study start, participants were given a full explanation of the aims of the study, the benefits, potential discomforts and risks of taking part in the study. Before any study procedure was started, study participants were also given a written explanation of the study procedures in the study information sheet and informed consent was obtained.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Nov 2010
    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
    Italy: 74
    Worldwide total number of subjects
    74
    EEA total number of subjects
    74
    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)
    24
    From 65 to 84 years
    50
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Due to difficulties in enrolment, the study was prematurely interrupted with 74 participants enrolled in total (all were randomized).

    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
    		 Participants received erlotinib (Tarceva) at a dose of 150 milligram per day (mg/day) orally as monotherapy, up to progressive disease (PD), death, or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Tarceva
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.

    Arm title
    		 Docetaxel and erlotinib
    Arm description
    		 Participants received docetaxel at a dose of 75 milligram per square meter (mg/m^2) as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Tarceva
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle for 4 cycles, in absence of PD, death, or unacceptable toxicity.

    Number of subjects in period 1
    		Erlotinib Docetaxel and erlotinib
    Started
    36
    38
    Treated
    36
    37
    Completed
    5
    2
    Not completed
    31
    36
         Consent withdrawn by subject
    2
    4
         Randomized, but not treated
    -
    1
         Death
    26
    27
         Lost to follow-up
    3
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Erlotinib
    Reporting group description
    		 Participants received erlotinib (Tarceva) at a dose of 150 milligram per day (mg/day) orally as monotherapy, up to progressive disease (PD), death, or unacceptable toxicity.

    Reporting group title
    Docetaxel and erlotinib
    Reporting group description
    		 Participants received docetaxel at a dose of 75 milligram per square meter (mg/m^2) as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.

    Reporting group values
    		 Erlotinib Docetaxel and erlotinib Total
    Number of subjects
    		 36 38 74
    Age categorical
    Units: Subjects
    Age continuous
    Data for Age continuous were reported for treated (73) participants only.
    Units: years
        arithmetic mean (standard deviation)
    		 68.4 ± 8.3 65.9 ± 8.1 -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 1
        Male
    		 36 36 72
        Not available
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Erlotinib
    Reporting group description
    		 Participants received erlotinib (Tarceva) at a dose of 150 milligram per day (mg/day) orally as monotherapy, up to progressive disease (PD), death, or unacceptable toxicity.

    Reporting group title
    Docetaxel and erlotinib
    Reporting group description
    		 Participants received docetaxel at a dose of 75 milligram per square meter (mg/m^2) as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.

    Primary: Percentage of Participants Free From Disease Progression or Death at 6 Months

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    End point title
    		 Percentage of Participants Free From Disease Progression or Death at 6 Months [1]
    End point description
    According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, progressive Disease (PD) is defined as: for Target Lesions - At least a 20 percent (%) 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 millimeter (mm). (Note: the appearance of one or more new lesions is also considered progression). For Non-Target Lesions - Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression). Analysis was performed on Full Analysis Set (FAS) defined as all randomized participants who received at least one dose of study medication. Participants were analyzed according to treatment received.
    End point type
    Primary
    End point timeframe
    Month 6
    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: Statistical hypothesis testing was not planned for this study. Therefore, only descriptive statistical methods were applied and reported.
    End point values
    		 Erlotinib Docetaxel and erlotinib
    Number of subjects analysed
    36
    37
    Units: percentage of participants
        number (confidence interval 95%)
    8.3 (0 to 17.4)
    8.1 (0 to 16.9)
    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
    Progression-free Survival (PFS) was defined as the interval (in days) between the date of randomization and the first documentation of progressive disease or death from any cause. Participants alive and progression-free were considered as censored at the date of the last tumor assessment when the participant was known to be progression‐free. Participants without post‐baseline tumor assessment, but known to be alive, were censored at the time of randomization. PFS (days) = (Date of Event ‐ Date of Randomization) + 1. PFS was assessed using the Kaplan‐Meier method. Detailed definition of PD is provided in Outcome Measure “Percentage of Participants Free From Disease Progression or Death at 6 Months”. Analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    From randomization until progressive disease or death, assessed up to 18 months
    End point values
    		 Erlotinib Docetaxel and erlotinib
    Number of subjects analysed
    36
    37
    Units: months
        median (confidence interval 95%)
    2.33 (2.13 to 4.13)
    2.82 (2.3 to 3.97)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall survival (OS) was defined as the interval (in days) between the date of randomization and death from any cause. Participants alive at the time of the analysis were censored at the date they were last known to be alive. OS was assessed using the Kaplan‐Meier method. Analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    From randomization until death, assessed up to 18 months
    End point values
    		 Erlotinib Docetaxel and erlotinib
    Number of subjects analysed
    36
    37
    Units: months
        median (confidence interval 95%)
    5.61 (3.54 to 8.69)
    8.95 (6.13 to 10.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)

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    End point title
    		 Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)
    End point description
    Best overall response (CR or PR) was defined as the best response recorded from the start of the treatment until disease progression (PD). Best response in this trial was defined as the best response observed at any post-treatment visits. According to RECIST Version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [>=] 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    From randomization until progressive disease or death, assessed up to 18 months
    End point values
    		 Erlotinib Docetaxel and erlotinib
    Number of subjects analysed
    36
    37
    Units: percentage of participants
        number (confidence interval 95%)
    2.8 (0 to 8.15)
    8.1 (0 to 16.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Disease Control

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    End point title
    		 Percentage of Participants With Disease Control
    End point description
    Disease control was defined as PR, CR, or SD. Participants who did not achieve a CR or PR or SD were counted as non‐responders in the analysis of disease control. According to RECIST Version 1.1, SD was defined as not qualifying for CR, PR, and PD. Detailed definitions of CR and PR are provided in Outcome Measure “Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)”. Analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    From randomization until progressive disease or death, assessed up to 18 months
    End point values
    		 Erlotinib Docetaxel and erlotinib
    Number of subjects analysed
    36
    37
    Units: percentage of participants
        number (confidence interval 95%)
    41.7 (25.6 to 57.8)
    37.8 (22.2 to 53.5)
    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
    Duration of response (DoR) was defined as the interval (in days) from first documentation of a response (CR/PR depending on which occurred first) to the date of the first documentation of disease progression or death from any cause. Participants presenting a response were considered as censored at the date of the last assessment with a documentation of non-progression. DoR (days) = (Date of PD/death ‐ Date of CR/PR) + 1. Assessments were performed according to RECIST Version 1.1. DoR was assessed using the Kaplan‐Meier method. Detailed definitions of CR and PR are provided in Outcome Measure “Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)”. Analysis was performed on FAS population. 99999 = Not estimable because the only participant evaluable was censored.
    End point type
    Secondary
    End point timeframe
    From randomization until progressive disease or death, assessed up to 18 months
    End point values
    		 Erlotinib Docetaxel and erlotinib
    Number of subjects analysed
    1 [2]
    3 [3]
    Units: months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    8.69 (1.87 to 10.8)
    Notes
    [2] - Number of participants analyzed signifies participants who had a best overall response of CR or PR.
    [3] - Number of participants analyzed signifies participants who had a best overall response of CR or PR.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 18 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Erlotinib
    Reporting group description
    		 Participants received erlotinib (Tarceva) at a dose of 150 milligram per day (mg/day) orally as monotherapy, up to progressive disease (PD), death, or unacceptable toxicity.

    Reporting group title
    Docetaxel and erlotinib
    Reporting group description
    		 Participants received docetaxel at a dose of 75 milligram per square meter (mg/m^2) as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.

    Serious adverse events
    		 Erlotinib Docetaxel and erlotinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 36 (41.67%)
    10 / 37 (27.03%)
         number of deaths (all causes)
    26
    27
         number of deaths resulting from adverse events
    Vascular disorders
    Angiopathy
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac tamponade
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 36 (0.00%)
    4 / 37 (10.81%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Performance status decreased
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Uncoded
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         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 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Gastrointestinal ulcer haemorrhage
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cough
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 36 (8.33%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (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
    Muscular weakness
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Sepsis
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Erlotinib Docetaxel and erlotinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 36 (88.89%)
    35 / 37 (94.59%)
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 36 (0.00%)
    3 / 37 (8.11%)
         occurrences all number
    0
    3
    Nervous system disorders
    Coordination abnormal
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Dysgeusia
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 36 (11.11%)
    3 / 37 (8.11%)
         occurrences all number
    4
    4
    Leukopenia
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    3
    Neutropenia
         subjects affected / exposed
    0 / 36 (0.00%)
    9 / 37 (24.32%)
         occurrences all number
    0
    11
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 36 (22.22%)
    10 / 37 (27.03%)
         occurrences all number
    8
    11
    Chest pain
         subjects affected / exposed
    5 / 36 (13.89%)
    0 / 37 (0.00%)
         occurrences all number
    5
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 36 (0.00%)
    5 / 37 (13.51%)
         occurrences all number
    0
    9
    Pyrexia
         subjects affected / exposed
    4 / 36 (11.11%)
    6 / 37 (16.22%)
         occurrences all number
    6
    6
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    3 / 36 (8.33%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Diarrhoea
         subjects affected / exposed
    9 / 36 (25.00%)
    14 / 37 (37.84%)
         occurrences all number
    15
    21
    Dyspepsia
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Dysphagia
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    2 / 36 (5.56%)
    3 / 37 (8.11%)
         occurrences all number
    2
    3
    Vomiting
         subjects affected / exposed
    0 / 36 (0.00%)
    5 / 37 (13.51%)
         occurrences all number
    0
    5
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    3 / 36 (8.33%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 36 (11.11%)
    0 / 37 (0.00%)
         occurrences all number
    5
    0
    Dyspnoea
         subjects affected / exposed
    3 / 36 (8.33%)
    7 / 37 (18.92%)
         occurrences all number
    4
    7
    Epistaxis
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Haemoptysis
         subjects affected / exposed
    3 / 36 (8.33%)
    0 / 37 (0.00%)
         occurrences all number
    4
    0
    Productive cough
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Erythema
         subjects affected / exposed
    3 / 36 (8.33%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Pruritus
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    16 / 36 (44.44%)
    12 / 37 (32.43%)
         occurrences all number
    26
    22
    Urticaria
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Neck pain
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 36 (5.56%)
    3 / 37 (8.11%)
         occurrences all number
    2
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jan 2011
    Substantial changes in study design and conduct

    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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    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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