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    Clinical Trial Results:
    SINGLE AGENT JNJ-56022473 IN MDS AND AML PATIENTS FAILING HYPOMETHYLATING AGENT BASED THERAPY

    Summary
    EudraCT number
    2016-000327-10
    Trial protocol
    DE   FR  
    Global end of trial date
    31 Oct 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Dec 2019
    First version publication date
    29 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SAMBA
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02992860
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GWT-TUD GmbH
    Sponsor organisation address
    Freiberger Straße 33, Dresden, Germany, 01067
    Public contact
    Medical Consulting, GWT-TUD GmbH, +49 35125933193, martin.puttrich@gwtonline.de
    Scientific contact
    Medical Consulting, GWT-TUD GmbH, +49 35125933193, martin.puttrich@gwtonline.de
    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
    25 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the efficacy of JNJ-56022473 for the treatment of MDS and AML patients who have relapsed after or are refractory to treatment with HMAs
    Protection of trial subjects
    The conduct, evaluation, and documentation of this study, was in compliance with the Good Clinical Practice Guidelines and under the guiding principles detailed in the Declaration of Helsinki. The study was also be carried out in keeping with applicable local law(s) and regulation(s). No further specific measures had to be put in place, because it had been assumed, that 9 mg/kg every 14 days is a well tolerated dose and would be the lowest dose that provides adequate exposure and sustained target saturation at the site of action throughout the entire dosing interval.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Nov 2016
    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
    Germany: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    0
    From 65 to 84 years
    23
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    The trial was conducted at 6 study sites in Germany, whereas only 4 sites recruited patients into the study. From November 2016 on a total of 24 patients had been included in the study and treated with study medication before it was prematurely terminated.

    Pre-assignment
    Screening details
    Screening period started with the patients consent and must completed within 28 days prior initiation of study treatment. Out of 28 screened patients 3 patient became a screening failure and 1 patient have had an SAE prior start of treatment.

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

    Arms
    Arm title
    Talacotuzumab
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Talacotuzumab
    Investigational medicinal product code
    Other name
    JNJ-56022473
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    9 mg / kg body weight every two weeks

    Number of subjects in period 1
    Talacotuzumab
    Started
    24
    Completed
    10
    Not completed
    14
         Adverse event, serious fatal
    6
         Consent withdrawn by subject
    2
         Physician decision
    1
         Adverse event, non-fatal
    1
         Lack of efficacy
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    -

    Reporting group values
    overall trial Total
    Number of subjects
    24 24
    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)
    0 0
        From 65-84 years
    23 23
        85 years and over
    1 1
    Gender categorical
    Units: Subjects
        Female
    7 7
        Male
    17 17

    End points

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    End points reporting groups
    Reporting group title
    Talacotuzumab
    Reporting group description
    -

    Primary: Overall hematological response rate at 3 months

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    End point title
    Overall hematological response rate at 3 months [1]
    End point description
    All patients with one of the following response states at the 3 months response assessment (V6) are defined as responder: •Complete remission (CR), Partial remission (PR), marrow CR, Stable disease (SD) for MDS or •Hematologic improvement for MDS or •CR, Complete remission with incomplete recovery (CRi), morphologic leukemia free state, PR, Cytogenetic complete remission (CRc), Molecular complete remission (CRm), SD for AML
    End point type
    Primary
    End point timeframe
    at 3 months (week 11)
    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: As the study had been terminated prematurely, no formal statistical analysis on study endpoints was performed. Available data were only listed and summarized descriptively.
    End point values
    Talacotuzumab
    Number of subjects analysed
    24
    Units: number of patients
    24
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The observation phase for AEs started with signing the informed consent form and ended 28 days after the last intake of study drug, unless the investigator suspects a delayed adverse reaction to the study drug.
    Adverse event reporting additional description
    In case of ongoing AEs after the last follow-up visit – especially when related to treatment with the study medication – the respective AE has been followed until resolution, if possible.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Talacotuzumab
    Reporting group description
    -

    Serious adverse events
    Talacotuzumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 24 (100.00%)
         number of deaths (all causes)
    11
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infusion related infection
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Vascular disorders
    Superior vena cava syndrome
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Thrombosis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pericardial effusion
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General physical health deterioration
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal angiectasia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal hemorrhage
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Ulcer
         subjects affected / exposed
    1 / 24 (4.17%)
         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 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Decice related infection
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Escherichia infection
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenic infection
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 24 (25.00%)
         occurrences causally related to treatment / all
    2 / 6
         deaths causally related to treatment / all
    1 / 3
    Pneumonia fungal
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    Staphylococcal infection
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Diabetic hyperglycaemic coma
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Talacotuzumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 24 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Haematoma
         subjects affected / exposed
    5 / 24 (20.83%)
         occurrences all number
    6
    Hypertension
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Pallor
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Phlebitis
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Surgical and medical procedures
    Temporomandibular joint surgery
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Chest discomfort
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Chest pain
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Chills
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    5 / 24 (20.83%)
         occurrences all number
    5
    Feeling hot
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Infusion site erythema
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Injection site erythema
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Mucosal haemorrhage
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Mucosal inflammation
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Oedema
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    4
    Pain
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    5
    Peripheral swelling
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    7 / 24 (29.17%)
         occurrences all number
    19
    Sinusitis
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Immune system disorders
    Decreased immune responsiveness
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Testicular oedema
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    5 / 24 (20.83%)
         occurrences all number
    5
    Dyspnoea exertional
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    4
    Epistaxis
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Pleural effusion
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Stridor
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Disorientation
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Blood glucose decreased
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    C-reactive protein increased
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    4
    Infusion related reaction
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    7
    Wound haematoma
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Tachyarrhythmia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Tachycardia
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Paraparesis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Phantom pain
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    4
    Neutropenia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Splenomegaly
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Eye disorders
    Visual impairment
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    4
    Constipation
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    7 / 24 (29.17%)
         occurrences all number
    7
    Dysphagia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Gingival bleeding
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Intra-abdominal haematoma
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Lip swelling
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    5
    Stomatitis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Tongue discolouration
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    2
    Petechiae
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Hydronephrosis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    2
    Back pain
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    12
    Muscle tightness
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    3
    Pathological fracture
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Infections and infestations
    Aspergillus infection
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Sepsis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    4
    Wound sepsis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Dehydration
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    2
    Hypokalaemia
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Type 3 diabetes mellitus
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Vitamin D deficiency
         subjects affected / exposed
    1 / 24 (4.17%)
         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
    22 Feb 2017
    Version 3.0 dated 10 Jan 2017 was issued to include new information from the updated safety reference document.
    13 Sep 2017
    Version 5.0 dated 28 Jul 2017 was issued to adjust the section “drug administration” according to updated safety information.

    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.
    Recruitment was stopped in July 2017 due to results from a pivotal study which indicated added toxicity and lack of efficacy of talacotuzumab.
    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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