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    Clinical Trial Results:
    Phase 2 Study of Single-Agent PF-03084014 in Patients With Advanced Triple-Negative Breast Cancer With or Without Genomic Alterations in Notch Receptors

    Summary
    EudraCT number
    		 2014-002286-30
    Trial protocol
    		 GB   IT   BE   ES   DE   HU  
    Global end of trial date
    26 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Dec 2016
    First version publication date
    04 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A8641020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    31 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the objective response rate (ORR) of PF-03084014 when given as a single agent in the treatment of patients with advanced triple receptor-negative breast cancer (mTNBC) harboring activating genomic alterations in Notch receptors (NA+).
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2015
    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
    Italy: 5
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    19
    EEA total number of subjects
    13
    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)
    15
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 30 subjects were planned to be enrolled in the study: 15 subjects each with NA+ mTNBC and NA-mTNBC.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PF-03084014
    Arm description
    		 PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, unacceptable toxicity, patient refusal of further treatment, patient withdrawal of consent or death, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-03084014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PF-03084014 at the starting dose of 150 mg BID (in the form of one 100 mg and one 50-mg tablet) was to be administered orally BID continuously in 21-day cycles.

    Number of subjects in period 1
    		PF-03084014
    Started
    19
    Completed
    0
    Not completed
    19
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    2
         Global deterioration of health status
    1
         Adverse event, non-fatal
    2
         Unspecified
    3
         Objective progression or relapse
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-03084014
    Reporting group description
    		 PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, unacceptable toxicity, patient refusal of further treatment, patient withdrawal of consent or death, whichever occurred first.

    Reporting group values
    		 PF-03084014 Total
    Number of subjects
    		 19 19
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.4 ( 12.1 ) -
    Gender, Male/Female
    Units: Participants
        Male
    		 0 0
        Female
    		 19 19

    End points

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    End points reporting groups
    Reporting group title
    PF-03084014
    Reporting group description
    		 PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, unacceptable toxicity, patient refusal of further treatment, patient withdrawal of consent or death, whichever occurred first.

    Primary: Objective Response (OR) Rate in Subjects With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+)

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    End point title
    		 Objective Response (OR) Rate in Subjects With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+) [1]
    End point description
    OR status based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis less than [<]10 millimeter [mm]). PR: Greater than or equal to (>=)30% decrease under baseline of the sum of diameters of all target measurable lesions.
    End point type
    Primary
    End point timeframe
    Every 6 weeks
    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: Data for this outcome measure was not collected due to early termination of this study.
    End point values
    		 PF-03084014
    Number of subjects analysed
    0 [2]
    Units: percentage of subjects
        number (confidence interval 95%)
    ( to )
    Notes
    [2] - Data for this outcome measure was not collected due to early termination of this study.
    No statistical analyses for this end point

    Secondary: OR Rate in Subjects With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-)

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    End point title
    		 OR Rate in Subjects With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-)
    End point description
    OR status based on assessment of confirmed CR or confirmed PR according to RECIST version 1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis <10 millimeter [mm]). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions.
    End point type
    Secondary
    End point timeframe
    Every 6 weeks
    End point values
    		 PF-03084014
    Number of subjects analysed
    0 [3]
    Units: percentage of subjects
        number (confidence interval 95%)
    ( to )
    Notes
    [3] - Data for this outcome measure was not collected due to early termination of this study.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) in Subjects With NA+ or NA mTNBC

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    End point title
    		 Progression-Free Survival (PFS) in Subjects With NA+ or NA mTNBC
    End point description
    The period from study entry until disease progression, death, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 PF-03084014
    Number of subjects analysed
    0 [4]
    Units: months
        median (confidence interval 95%)
    ( to )
    Notes
    [4] - Data for this outcome measure was not collected due to early termination of this study.
    No statistical analyses for this end point

    Secondary: Duration of Response (DR) in Participants With NA+ or NA mTNBC

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    End point title
    		 Duration of Response (DR) in Participants With NA+ or NA mTNBC
    End point description
    Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated for the subgroup of patients with a confirmed objective tumor response.
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 PF-03084014
    Number of subjects analysed
    0 [5]
    Units: months
        median (confidence interval 95%)
    ( to )
    Notes
    [5] - Data for this outcome measure was not collected due to early termination of this study.
    No statistical analyses for this end point

    Secondary: One-Year Survival Probability in Subjects With NA+ or NA mTNBC

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    End point title
    		 One-Year Survival Probability in Subjects With NA+ or NA mTNBC
    End point description
    Overall survival (OS) status (alive or not) at 1 year after study entry. The 1-year OS probability was summarized as a product limit estimator based on the Kaplan-Meier method to account for censored events.
    End point type
    Secondary
    End point timeframe
    1 year
    End point values
    		 PF-03084014
    Number of subjects analysed
    0 [6]
    Units: percent chance of survival
        number (confidence interval 95%)
    ( to )
    Notes
    [6] - Data for this outcome measure was not collected due to early termination of this study.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) in Subjects With NA+ or NA mTNBC

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    End point title
    		 Overall Survival (OS) in Subjects With NA+ or NA mTNBC
    End point description
    OS was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 PF-03084014
    Number of subjects analysed
    0 [7]
    Units: subjects
        median (confidence interval 95%)
    ( to )
    Notes
    [7] - Data for this outcome measure was not collected due to early termination of this study.
    No statistical analyses for this end point

    Secondary: Type and Number of Notch Genomic Alterations in Subjects With NA+ mTNBC

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    End point title
    		 Type and Number of Notch Genomic Alterations in Subjects With NA+ mTNBC
    End point description
    Type and number of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 PF-03084014
    Number of subjects analysed
    0 [8]
    Units: subjects
        number (not applicable)
    Notes
    [8] - Data for this outcome measure was not collected due to early termination of this study.
    No statistical analyses for this end point

    Secondary: Pre-dose Serum Concentration (Ctrough) for PF-03084014

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    End point title
    		 Pre-dose Serum Concentration (Ctrough) for PF-03084014
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1, 2, 3, and 5
    End point values
    		 PF-03084014
    Number of subjects analysed
    0 [9]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    ( )
    Notes
    [9] - Due to study termination, no PK analyses were performed for this study.
    No statistical analyses for this end point

    Secondary: Pharmacodynamic (PD) Effects of PF‑03084014 in Tumor Specimens and Peripheral Blood

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    End point title
    		 Pharmacodynamic (PD) Effects of PF‑03084014 in Tumor Specimens and Peripheral Blood
    End point description
    Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1, 2, 3, and 5
    End point values
    		 PF-03084014
    Number of subjects analysed
    0 [10]
    Units: subjects
        number (not applicable)
    Notes
    [10] - Due to study termination, no PD analyses were performed for this study.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects with Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence without regard to causality in a subject who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 PF-03084014
    Number of subjects analysed
    19
    Units: subjects
        Number of Participants with AEs
    18
        Number of Participants with SAEs
    6
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment-Emergent AEs by CTCAE Grade

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    End point title
    		 Number of Subjects with Treatment-Emergent AEs by CTCAE Grade
    End point description
    An AE was any untoward medical occurrence without regard to causality in a subject who received study drug. AEs were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 PF-03084014
    Number of subjects analysed
    19
    Units: subjects
        Any AEs, Grade 1
    1
        Any AEs, Grade 2
    5
        Any AEs, Grade 3
    9
        Any AEs, Grade 4
    1
        Any AEs, Grade 5
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects with Laboratory Test (Hematology) Abnormalities

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    End point title
    		 Number of Subjects with Laboratory Test (Hematology) Abnormalities
    End point description
    Number of subjects with CTCAE version 4.03 grade 1 to 4 hematological test abnormalities.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycles 1, 2, 3, 4, 5, and subsequent cycles.
    End point values
    		 PF-03084014
    Number of subjects analysed
    19
    Units: subjects
        Anemia
    12
        Lymphocyte count increased
    0
        Lymphopenia
    11
        Neutrophils (absolute)
    0
        Platelets
    3
        White blood cells
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects with Laboratory Test (Chemistry) Abnormalities

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    End point title
    		 Number of Subjects with Laboratory Test (Chemistry) Abnormalities
    End point description
    Number of subjects with CTCAE version 4.03 grade 1 to 4 chemistry test abnormalities
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 15 of Cycles 1, 2, 3, 4, 5, and subsequent cycles up to Cycle 8 and Day 8 of Cycle 1
    End point values
    		 PF-03084014
    Number of subjects analysed
    19
    Units: Number of subjects
        Alanine aminotransferase
    5
        Alkaline phosphatase
    6
        Aspartate aminotransferase
    9
        Bilirubin (total)
    1
        Creatine kinase
    1
        Creatinine
    13
        Gamma glutamyl transferase
    1
        Hypercalcemia
    3
        Hyperglycemia
    13
        Hyperkalemia
    3
        Hypermagnesemia
    1
        Hypernatremia
    0
        Hypoalbuminemia
    8
        Hypocalcemia
    4
        Hypoglycemia
    1
        Hypokalemia
    5
        Hypomagnesemia
    3
        Hyponatremia
    6
        Hypophosphatemia
    14
    No statistical analyses for this end point

    Secondary: Number of Subjects with Laboratory Test (Urinalysis) Abnormalities

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    End point title
    		 Number of Subjects with Laboratory Test (Urinalysis) Abnormalities
    End point description
    Number of subjects with CTCAE version 4.03 grade 1 to 4 urinalysis test abnormalities for urine protein.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1
    End point values
    		 PF-03084014
    Number of subjects analysed
    19
    Units: Number of subjects
    2
    No statistical analyses for this end point

    Post-hoc: Alterations in Genes, Proteins, and RNAs Relevant to the Notch Signaling Pathway, to TNBC Biology, and to Sensitivity/Resistance to PF-03084014 in Tumor Specimens and Peripheral Blood.

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    End point title
    		 Alterations in Genes, Proteins, and RNAs Relevant to the Notch Signaling Pathway, to TNBC Biology, and to Sensitivity/Resistance to PF-03084014 in Tumor Specimens and Peripheral Blood.
    End point description
    Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes.
    End point type
    Post-hoc
    End point timeframe
    Day 1 of Cycle 1, 2, 3, and 5
    End point values
    		 PF-03084014
    Number of subjects analysed
    0 [11]
    Units: subjects
        number (not applicable)
    Notes
    [11] - Due to study termination, no PD analyses were performed for the study.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 years
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    PF-03084014
    Reporting group description
    		 PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100 mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles.

    Serious adverse events
    		 PF-03084014
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 19 (31.58%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    Pyrexia
         subjects affected / exposed
    1 / 19 (5.26%)
         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
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Lung infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypophosphataemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PF-03084014
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 19 (94.74%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour exudation
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Tumour haemorrhage
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Tumour pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Chest pain
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    8 / 19 (42.11%)
         occurrences all number
    10
    Mucosal inflammation
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    5
    Oedema peripheral
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    5 / 19 (26.32%)
         occurrences all number
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 19 (26.32%)
         occurrences all number
    7
    Nasal congestion
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Productive cough
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    5
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood chloride decreased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Carbon dioxide increased
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Protein total increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Lethargy
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    3
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    5
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Eye disorders
    Eye discharge
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Photopsia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Vitreous floaters
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    11 / 19 (57.89%)
         occurrences all number
    16
    Dry mouth
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    8 / 19 (42.11%)
         occurrences all number
    13
    Oral pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    7 / 19 (36.84%)
         occurrences all number
    13
    Skin and subcutaneous tissue disorders
    Nail dystrophy
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    7
    Rash macular
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Flank pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    3
    Muscular weakness
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Neck pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Gastroenteritis viral
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Urinary tract infection
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Hypercalcaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    8
    Hypophosphataemia
         subjects affected / exposed
    7 / 19 (36.84%)
         occurrences all number
    21
    Hypouricaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         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 Sep 2014
    Protocol Amendment 1
    16 Feb 2015
    Protocol Amendment 2
    20 Apr 2015
    Protocol Amendment 3

    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.
    This study was terminated prematurely based on project re-prioritization by the Sponsor and was not due to any safety concerns or regulatory actions.
    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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