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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients with Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases

    Summary
    EudraCT number
    		 2012-004369-42
    Trial protocol
    		 BE   ES   GB   IT   DE   FR  
    Global end of trial date
    29 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2017
    First version publication date
    18 Aug 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BAY73-4506/15983
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01939223
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee , Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2013
    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
    Spain: 5
    Country: Number of subjects enrolled
    United States: 4
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    China: 1
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Japan: 5
    Worldwide total number of subjects
    25
    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)
    18
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This multinational study was conducted at 32 study centers that screened 65 subjects across 9 countries, between 02 December 2013 (start of enrollment) and 29 August 2016 (last patient last vist).

    Pre-assignment
    Screening details
    		 Overall, 65 subjects were screened, of which 40 were screen failures. The remaining 25 subjects were randomized and assigned to treatment. All 25 subjects received treatment.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Regorafenib 160 mg
    Arm description
    		 Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Regorafenib
    Investigational medicinal product code
    BAY73-4506
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.

    Number of subjects in period 1
    		Regorafenib 160 mg Placebo
    Started
    14
    11
    Participants received treatment
    14
    11
    Completed
    1
    0
    Not completed
    13
    11
         AE not associated with disease recurrence
    1
    1
         Consent withdrawn by subject
    6
    -
         Disease recurrence (radiological recurrence)
    1
    3
         Study stopped by Sponsor
    5
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Regorafenib 160 mg
    Reporting group description
    		 Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.

    Reporting group values
    		 Regorafenib 160 mg Placebo Total
    Number of subjects
    		 14 11 25
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.7 ( 11.22 ) 57 ( 9.83 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 5 14
        Male
    		 5 6 11

    End points

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    End points reporting groups
    Reporting group title
    Regorafenib 160 mg
    Reporting group description
    		 Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set (FAS) (N = 25): all subjects who were assigned to treatment.

    Primary: Disease Free Survival (DFS) as assessed by the investigator

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    End point title
    		 Disease Free Survival (DFS) as assessed by the investigator [1]
    End point description
    Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last evaluable CT / MRI scan.
    End point type
    Primary
    End point timeframe
    From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented.
    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: This study was prematurely terminated. Analysis was not performed for this endpoint.
    End point values
    		 Regorafenib 160 mg Placebo Full analysis set (FAS)
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: days
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [2] - This study was prematurely terminated. Analysis was not performed for this endpoint.
    [3] - This study was prematurely terminated. Analysis was not perfomed for this endpoint.
    [4] - This study was prematurely terminated. Analysis was not perfomed for this endpoint.
    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) is defined as the time (days) from randomization to death due to any cause. The OS time for subjects alive at the time of analysis will be censored at their last date known to be alive.
    End point type
    Secondary
    End point timeframe
    Subjects who experienced disease recurrence (either during treatment or during Active Follow-up), or otherwise withdrew from the study for any reason other than death, were followed for overall survival unless consent was withdrawn.
    End point values
    		 Regorafenib 160 mg Placebo Full analysis set (FAS)
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: days
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [5] - This study was prematurely terminated. Analysis was not perfomed for this endpoint.
    [6] - This study was prematurely terminated. Analysis was not perfomed for this endpoint.
    [7] - This study was prematurely terminated. Analysis was not perfomed for this endpoint.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study treatment until 30 days after the last study drug intake
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Regorafenib 160 mg (BAY73-4506)
    Reporting group description
    		 Subjects received regorafenib 160 mg (4 *40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care).

    Serious adverse events
    		 Regorafenib 160 mg (BAY73-4506) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema multiforme
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised erythema
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    		 Regorafenib 160 mg (BAY73-4506) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 14 (92.86%)
    10 / 11 (90.91%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hair follicle tumour benign
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    7 / 14 (50.00%)
    1 / 11 (9.09%)
         occurrences all number
    29
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 14 (28.57%)
    2 / 11 (18.18%)
         occurrences all number
    6
    2
    Chills
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 14 (14.29%)
    3 / 11 (27.27%)
         occurrences all number
    2
    3
    Mucosal inflammation
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    2
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Oedema
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    5 / 14 (35.71%)
    1 / 11 (9.09%)
         occurrences all number
    5
    1
    Nasal congestion
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Rhinitis atrophic
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 11 (9.09%)
         occurrences all number
    6
    2
    Amylase increased
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 14 (28.57%)
    0 / 11 (0.00%)
         occurrences all number
    10
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Blood bilirubin increased
         subjects affected / exposed
    5 / 14 (35.71%)
    0 / 11 (0.00%)
         occurrences all number
    7
    0
    Blood bilirubin unconjugated increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Blood creatinine decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 11 (9.09%)
         occurrences all number
    2
    1
    Lipase increased
         subjects affected / exposed
    4 / 14 (28.57%)
    1 / 11 (9.09%)
         occurrences all number
    7
    4
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Neutrophil count decreased
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    Neutrophil count increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Platelet count decreased
         subjects affected / exposed
    4 / 14 (28.57%)
    0 / 11 (0.00%)
         occurrences all number
    9
    0
    Weight decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Weight increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    White blood cell count decreased
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 11 (0.00%)
         occurrences all number
    5
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    White blood cells urine positive
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Thermal burn
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 11 (9.09%)
         occurrences all number
    2
    1
    Neuropathy peripheral
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Febrile neutropenia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Anal fistula
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Cheilitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    4 / 14 (28.57%)
    2 / 11 (18.18%)
         occurrences all number
    5
    2
    Dental caries
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 14 (7.14%)
    3 / 11 (27.27%)
         occurrences all number
    1
    5
    Flatulence
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Gingival pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 11 (9.09%)
         occurrences all number
    1
    2
    Stomatitis
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 11 (18.18%)
         occurrences all number
    2
    2
    Toothache
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Dermatitis acneiform
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Dermatitis bullous
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Erythema multiforme
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    Generalised erythema
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Hyperkeratosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    6 / 14 (42.86%)
    1 / 11 (9.09%)
         occurrences all number
    22
    1
    Pruritus
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 11 (9.09%)
         occurrences all number
    2
    1
    Rash generalised
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Glycosuria
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Proteinuria
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Urinary retention
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    2
    Bone pain
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Muscle spasms
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 11 (9.09%)
         occurrences all number
    2
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    3 / 14 (21.43%)
    2 / 11 (18.18%)
         occurrences all number
    4
    2
    Pain in extremity
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Infections and infestations
    Abscess oral
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Device related infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Enterocolitis infectious
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Genital infection fungal
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Laryngitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Diabetes mellitus
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    Hyperglycaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 11 (9.09%)
         occurrences all number
    2
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 May 2014
    - Clarification that the maximum treatment period is up to 2 years (a maximum of 26 Cycles). - Stage 0 gastric cancer added as a permitted prior and concurrent cancer. - An inclusion criterion was modified with respect to previous treatments / treatment duration total length of chemotherapy allowed was extended from 6 to 9 months. - Subjects who present with initial Stage I or II disease and then develop liver metastases and fulfill all of the other eligibility criteria were allowed to be enrolled.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    05 Mar 2015
    Early termination of enrollment due to slow enrollment.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Decimal places were automatically truncated if last decimal equals zero. This study was prematurely terminated. Analysis was not perfomed for primary and secondary outcome measures.
    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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