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    Clinical Trial Results:
    Phase II trial of dasatinib in subjects with advanced cancers harboring DDR2 mutation or inactivating B-RAF mutation

    Summary
    EudraCT number
    		 2011-003128-11
    Trial protocol
    		 DE   PL   GB  
    Global end of trial date
    23 Jul 2014

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CA180-385
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01514864
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to assess the clinical activity of dasatinib, defined as objective response rate, in subjects with cancer harboring discoidin domain receptor 2 (DDR2) mutation or inactivating B-RAF mutation.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2012
    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
    Poland: 1
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    19
    EEA total number of subjects
    12
    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)
    7
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at 10 sites (out of 13 sites which participated in the study).

    Pre-assignment
    Screening details
    		 A total of 19 subjects were enrolled, and 14 received treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open label, hence blinding was not applicable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
    Arm description
    		 Subjects with non-small cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    BMS-354825
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasatinib 50-mg and 20-mg tablets were administered orally as two tablets each taken once per day at the same time to receive a daily dose of 140 mg, until unacceptable toxicity or disease progression was observed by the investigator.

    Arm title
    		 Dasatinib, 140 mg (Squamous-cell NSCLC With DDR2 Mutation)
    Arm description
    		 Subjects with NSCLC of squamous-cell type with DDR2 mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    BMS-354825
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasatinib 50-mg and 20-mg tablets were administered orally as two tablets each taken once per day at the same time to receive a daily dose of 140 mg, until unacceptable toxicity or disease progression was observed by the investigator.

    Number of subjects in period 1 [1]
    		Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) Dasatinib, 140 mg (Squamous-cell NSCLC With DDR2 Mutation)
    Started
    9
    5
    Completed
    0
    0
    Not completed
    9
    5
         Disease progression
    7
    5
         Study Drug Toxicity
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 19 subjects were enrolled and 14 received treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
    Reporting group description
    		 Subjects with non-small cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred.

    Reporting group title
    Dasatinib, 140 mg (Squamous-cell NSCLC With DDR2 Mutation)
    Reporting group description
    		 Subjects with NSCLC of squamous-cell type with DDR2 mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred.

    Reporting group values
    		 Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) Dasatinib, 140 mg (Squamous-cell NSCLC With DDR2 Mutation) Total
    Number of subjects
    		 9 5 14
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 3 6
        From 65-84 years
    		 6 2 8
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.7 ( 8.23 ) 62.4 ( 9.21 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 1 6
        Male
    		 4 4 8
    Race
    Units: Subjects
        White
    		 8 4 12
        Black or African American
    		 0 1 1
        American Indian or Alaska Native
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 1 0 1
        Not Hispanic/Latino
    		 5 5 10
        Not reported
    		 3 0 3
    Tumor Type
    Units: Subjects
        Non-small cell lung carcinoma
    		 9 5 14
    Non-small cell lung carcinoma
    Units: Subjects
        Adenocarcinoma
    		 7 1 8
        Bronco-alveolar carcinoma
    		 1 0 1
        Large cell carcinoma
    		 1 0 1
        Squamous cell carcinoma
    		 0 4 4
    Histopathologic Grade
    Units: Subjects
        G2-moderately differentiated
    		 2 2 4
        G3-poorly differentiated
    		 2 0 2
        GX-grade cannot be assessed
    		 5 3 8
    Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
    ECOG is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
    Units: Subjects
        Baseline ECOG score: 0
    		 1 1 2
        Baseline ECOG score: 1
    		 6 3 9
        Baseline ECOG score: 2
    		 2 1 3
    Number of Index Lesions
    Units: Subjects
        1 Lesion
    		 2 1 3
        2 Lesion
    		 0 2 2
        3 Lesion
    		 4 1 5
        4 Lesion
    		 3 1 4
    Time from cancer diagnosis to start of study therapy
    Units: Months
        median (full range (min-max))
    		 14.4 (6.2 to 21.7) 8.5 (1.5 to 51.6) -
    Subject analysis sets

    Subject analysis set title
    All treated subjects
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least 1 dose of study drug therapy during the study.

    Subject analysis sets values
    		 All treated subjects
    Number of subjects
    14
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    6
        From 65-84 years
    8
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63.9 ( 8.31 )
    Gender categorical
    Units: Subjects
        Female
    6
        Male
    8
    Race
    Units: Subjects
        White
    12
        Black or African American
    1
        American Indian or Alaska Native
    1
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    1
        Not Hispanic/Latino
    10
        Not reported
    3
    Tumor Type
    Units: Subjects
        Non-small cell lung carcinoma
    14
    Non-small cell lung carcinoma
    Units: Subjects
        Adenocarcinoma
    8
        Bronco-alveolar carcinoma
    1
        Large cell carcinoma
    1
        Squamous cell carcinoma
    4
    Histopathologic Grade
    Units: Subjects
        G2-moderately differentiated
    4
        G3-poorly differentiated
    2
        GX-grade cannot be assessed
    8
    Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
    ECOG is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
    Units: Subjects
        Baseline ECOG score: 0
    2
        Baseline ECOG score: 1
    9
        Baseline ECOG score: 2
    3
    Number of Index Lesions
    Units: Subjects
        1 Lesion
    3
        2 Lesion
    2
        3 Lesion
    5
        4 Lesion
    4
    Time from cancer diagnosis to start of study therapy
    Units: Months
        median (full range (min-max))
    12.1 (1.5 to 51.6)

    End points

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    End points reporting groups
    Reporting group title
    Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
    Reporting group description
    		 Subjects with non-small cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred.

    Reporting group title
    Dasatinib, 140 mg (Squamous-cell NSCLC With DDR2 Mutation)
    Reporting group description
    		 Subjects with NSCLC of squamous-cell type with DDR2 mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred.

    Subject analysis set title
    All treated subjects
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least 1 dose of study drug therapy during the study.

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR) [1]
    End point description
    ORR is defined as the percentage of subjects with best tumor response of either Partial Response (PR) (a 30% or greater decrease in the sum of the longest diameter [LD] of all lesions in reference to the baseline sum LD) or Complete Response (CR) (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors. The analysis was performed in all treated and response evaluable subject who received at least 1 dose of study drug. Response-evaluable subjects are defined as all treated subjects with >=1 measurable tumor at baseline and >=1 on-study tumor assessment (or with >=1 measurable tumor at baseline and a Clinical Progressive Disease (cPD) recorded).
    End point type
    Primary
    End point timeframe
    From enrollment of last subject to 24 months or until all subjects have died, whichever occurs first
    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: None of the subjects achieved ORR.
    End point values
    		 Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) Dasatinib, 140 mg (Squamous-cell NSCLC With DDR2 Mutation)
    Number of subjects analysed
    9
    5
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Duration of response is defined as the time from the first assessment with documentation of partial or complete response until the first with assessment documentation of disease progression. The analysis was performed in all the subjects who received at least 1 dose of study drug. Here ‘99999’ signifies not estimable data.
    End point type
    Secondary
    End point timeframe
    From enrollment of last subject to 24 months or until all subjects have died, whichever occurs first
    End point values
    		 Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) Dasatinib, 140 mg (Squamous-cell NSCLC With DDR2 Mutation)
    Number of subjects analysed
    9
    5
    Units: Months
        number (not applicable)
    99999
    99999
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the time from treatment start date to the date of death. If the subject did not die, survival was censored on the last date the subject was known to be alive. The analysis was performed in all the subjects who received at least 1 dose of the study drug. Here ‘99999’ signifies not estimable data as the upper limit of the Brookmeyer-Crowley confidence interval could not be estimated.
    End point type
    Secondary
    End point timeframe
    From enrollment of last subject to 24 months or until all subjects have died, whichever occurs first
    End point values
    		 Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) Dasatinib, 140 mg (Squamous-cell NSCLC With DDR2 Mutation)
    Number of subjects analysed
    9
    5
    Units: Months
        median (confidence interval 90%)
    3.06 (0.76 to 6.47)
    4.21 (0.82 to 99999)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS) Distribution

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    End point title
    		 Progression-free Survival (PFS) Distribution
    End point description
    PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Subjects who did not progress or die were censored on the date of their last tumor assessment. Here -99999 to 99999 signifies that no confidence interval is applicable when all subjects progressed.
    End point type
    Secondary
    End point timeframe
    From Day 1 of study treatment to Week 12
    End point values
    		 Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) Dasatinib, 140 mg (Squamous-cell NSCLC With DDR2 Mutation)
    Number of subjects analysed
    9
    5
    Units: Percentage of subjects
        number (confidence interval 90%)
    13.3 (1.4 to 38.8)
    0 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS)

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    End point title
    		 Progression-free Survival (PFS)
    End point description
    PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Subjects who die or whose disease does not progress will be censored on the date of their last tumor assessment. The analysis was performed in all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From Day 1 of study treatment to Week 12
    End point values
    		 Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) Dasatinib, 140 mg (Squamous-cell NSCLC With DDR2 Mutation)
    Number of subjects analysed
    9
    5
    Units: Months
        median (confidence interval 90%)
    1.41 (0.72 to 1.87)
    1.38 (0.59 to 2.96)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, and Deaths

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    End point title
    		 Number of Subjects With Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, and Deaths
    End point description
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug. The analysis was performed in all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From enrollment of last subject to 24 months or until all subjects have died, whichever occurs first
    End point values
    		 Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) Dasatinib, 140 mg (Squamous-cell NSCLC With DDR2 Mutation)
    Number of subjects analysed
    9
    5
    Units: Subjects
        Death
    8
    4
        Death within 30 days of last treatment
    3
    1
        SAEs
    7
    4
        Drug-related SAEs
    0
    1
        AEs leading to discontinuation
    7
    2
        Drug-related AEs leading to discontinuation
    2
    0
        Drug-related AEs
    6
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality

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    End point title
    		 Number of Subjects With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality
    End point description
    Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: <8.0 - 6.5 g/dL, <4.9-4.0 mmol/L, <80-65 g/L. Alkaline phosphatase, Grade 3: >5.0-20.0*upper limit of normal (ULN). Total bilirubin, Grade 3: >3.0-10.0*ULN. Calcium, low, Grade 3: <7.0-6.0 mg/dL, <1.75-1.5 mmol/L. The analysis was performed in all the subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From Day 1 of treatment to last day of treatment + 30 days
    End point values
    		 All treated subjects
    Number of subjects analysed
    14
    Units: Subjects
        Hemoglobin, Grade 3
    2
        Alkaline phosphatase, Grade 3
    1
        Total bilirubin, Grade 3
    1
        Calcium, low, Grade 3
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 of treatment to last day of treatment + 30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    All Treated Subjects
    Reporting group description
    		 All subjects who received at least 1 dose of study drug therapy.

    Serious adverse events
    		 All Treated Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 14 (78.57%)
         number of deaths (all causes)
    12
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    Neoplasm malignant
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Lipase increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diverticular perforation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Pleural effusion
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Panic reaction
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Lung infection
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All Treated Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Vasculitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 14 (50.00%)
         occurrences all number
    7
    Oedema peripheral
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Chest pain
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Oedema
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Pain
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Pyrexia
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    3
    Asthenia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Chills
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Extravasation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    6 / 14 (42.86%)
         occurrences all number
    6
    Cough
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    4
    Pleural effusion
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    4
    Haemoptysis
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Dyspnoea exertional
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nasal ulcer
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Productive cough
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Wheezing
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Confusional state
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    4
    Blood albumin decreased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Blood alkaline phosphatase
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Calcium ionised increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Lipase increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Neuropathy peripheral
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Parosmia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Sedation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Tremor
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Hearing impaired
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Eye disorders
    Eye disorder
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Eyelid oedema
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Uveitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 14 (35.71%)
         occurrences all number
    5
    Diarrhoea
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    4
    Vomiting
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Dysphagia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pancreatitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Diverticular perforation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Night sweats
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Urinary straining
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pain in jaw
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Groin pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Viral infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Apr 2012
    The purpose of this amendment was to remove subjects suffering from malignant melanoma with inactivating B-RAF mutation from the study design and inclusion of local laboratories to perform B-RAF and discoidin domain receptor 2 (DDR2) mutation testing (pre-screening).
    21 Aug 2013
    The purpose of this amendment was to allow subjects with non-squamous cell carcinoma of the lung in the stratum of subjects suffering from non-small cell lung cancer with DDR2 mutation.

    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.
    The study was terminated due to lack of efficacy and slow enrollment of subjects in the study.
    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.

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