Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)

    Summary
    EudraCT number
    2013-004516-21
    Trial protocol
    AT   ES   FR   PL   BE  
    Global end of trial date
    14 Mar 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Apr 2018
    First version publication date
    13 Apr 2018
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    IMMU-107-04
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Immunomedics, Inc.
    Sponsor organisation address
    300 The American Road, Morris Plains, United States, New Jersey 07950
    Public contact
    Diane Whiteley, Senior Director Regulatory Affairs, Immunomedics, Inc., 1 973-605-8200, dwhiteley@immunomedics.com
    Scientific contact
    Diane Whiteley, Senior Director Regulatory Affairs, Immunomedics, Inc., 1 973-605-8200, dwhiteley@immunomedics.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
    17 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Mar 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to demonstrate that patients with metastatic (Stage IV) pancreatic adenocarcinoma previously treated with at least 2 systemic chemotherapy regimens had increased overall survival (OS) if they received fractionated radioimmunotherapy with 90Y-clivatuzumab tetraxetan plus low-dose gemcitabine compared to those receiving placebo plus low-dose gemcitabine.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. To maximize therapeutic benefit, patients could have stopped treatment in the event of unacceptable toxicity, but otherwise received as many multiple cycles or doses as possible, following dose reduction guidelines to reduce, delay, or hold the study drugs in the event of hematological or other toxicities.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    31 Dec 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    1 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Spain: 81
    Country: Number of subjects enrolled
    Austria: 6
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    France: 23
    Country: Number of subjects enrolled
    United States: 196
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Israel: 4
    Worldwide total number of subjects
    333
    EEA total number of subjects
    125
    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)
    171
    From 65 to 84 years
    160
    85 years and over
    2

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The screening period was up to 4 weeks.

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm A
    Arm description
    90Y-clivatuzumab Tetraxetan + Gemcitabine
    Arm type
    Experimental

    Investigational medicinal product name
    90Y-clivatuzumab Tetraxetan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Three once-weekly doses of 6.5 mCi/m2 (240.5 MBq/m2) 90Y-clivatuzumab tetraxetan were administered on cycle weeks 2, 3 and 4 (cycle days 6, 13, and 20), and no study agent was administered on cycle weeks 5, 6 or 7. Each dose of 6.5 mCi/m2 (240.5 MBq/m2) 90Y-clivatuzumab tetraxetan was intravenously administered by slow push over 5 minutes or less.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Four once-weekly doses of 200 mg/m2 gemcitabine were administered on cycle weeks 1, 2, 3 and 4 (cycle days 1, 8, 15 and 22), and no study agent was administered on cycle weeks 5, 6 or 7. Each dose of gemcitabine was given intravenously over 30 minutes.

    Arm title
    Arm B
    Arm description
    Placebo + Gemcitabine
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Three once-weekly doses of placebo control were administered on cycle weeks 2, 3 and 4 (cycle days 6, 13, and 20), and no study agent was administered on cycle weeks 5, 6 or 7. Each dose of placebo control was intravenously administered by slow push over 5 minutes or less.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Four once-weekly doses of 200 mg/m2 gemcitabine were administered on cycle weeks 1, 2, 3 and 4 (cycle days 1, 8, 15 and 22), and no study agent was administered on cycle weeks 5, 6 or 7. Each dose of gemcitabine was given intravenously over 30 minutes.

    Number of subjects in period 1
    Arm A Arm B
    Started
    221
    112
    Completed
    0
    0
    Not completed
    221
    112
         Adverse event, serious fatal
    42
    13
         Consent withdrawn by subject
    21
    9
         Adverse event, non-fatal
    11
    4
         Progressive disease per imaging
    72
    48
         Other
    14
    4
         Not eligible prior to treatment
    8
    4
         Progressive disease clinical
    26
    15
         Sponsor decision
    27
    15

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    90Y-clivatuzumab Tetraxetan + Gemcitabine

    Reporting group title
    Arm B
    Reporting group description
    Placebo + Gemcitabine

    Reporting group values
    Arm A Arm B Total
    Number of subjects
    221 112 333
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    112 59 171
        From 65-84 years
    108 52 160
        85 years and over
    1 1 2
    Gender categorical
    Units: Subjects
        Female
    92 46 138
        Male
    129 66 195

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    90Y-clivatuzumab Tetraxetan + Gemcitabine

    Reporting group title
    Arm B
    Reporting group description
    Placebo + Gemcitabine

    Primary: Overall Survival

    Close Top of page
    End point title
    Overall Survival
    End point description
    End point type
    Primary
    End point timeframe
    Intent-to-Treat Population, cut-off date 17 April 2016.
    End point values
    Arm A Arm B
    Number of subjects analysed
    221
    112
    Units: Months
        number (confidence interval 95%)
    2.96 (2.53 to 3.71)
    2.92 (2.60 to 3.25)
    Statistical analysis title
    Treatment comparison (90Y versus placebo)
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.4362 [1]
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.75
         upper limit
    1.27
    Notes
    [1] - P-value (1-sided) was obtained using unstratified log rank test.

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    AE reporting continued for 30 days after either the last dose of study treatment or until the patient initiated alternative antineoplastic therapy not permitted during this study. Thereafter, AE reporting was limited to events judged study drug-related.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    90Y-clivatuzumab Tetraxetan + Gemcitabine
    Reporting group description
    -

    Reporting group title
    Placebo + Gemcitabine
    Reporting group description
    -

    Serious adverse events
    90Y-clivatuzumab Tetraxetan + Gemcitabine Placebo + Gemcitabine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    55 / 191 (28.80%)
    19 / 97 (19.59%)
         number of deaths (all causes)
    11
    0
         number of deaths resulting from adverse events
    11
    0
    Vascular disorders
    Embolism
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Local swelling
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    5 / 191 (2.62%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    8 / 191 (4.19%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    10 / 10
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic ulcer
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Embolic stroke
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive encephalopathy
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    2 / 191 (1.05%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 191 (2.62%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    5 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 191 (1.57%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 191 (1.57%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 191 (1.05%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic mass
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex encephalitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal infection
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 191 (1.05%)
    3 / 97 (3.09%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    90Y-clivatuzumab Tetraxetan + Gemcitabine Placebo + Gemcitabine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    185 / 191 (96.86%)
    87 / 97 (89.69%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 191 (1.57%)
    3 / 97 (3.09%)
         occurrences all number
    4
    4
    Hypotension
         subjects affected / exposed
    12 / 191 (6.28%)
    4 / 97 (4.12%)
         occurrences all number
    12
    5
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    40 / 191 (20.94%)
    13 / 97 (13.40%)
         occurrences all number
    71
    16
    Chills
         subjects affected / exposed
    12 / 191 (6.28%)
    3 / 97 (3.09%)
         occurrences all number
    18
    3
    Fatigue
         subjects affected / exposed
    67 / 191 (35.08%)
    33 / 97 (34.02%)
         occurrences all number
    91
    44
    Oedema peripheral
         subjects affected / exposed
    26 / 191 (13.61%)
    4 / 97 (4.12%)
         occurrences all number
    35
    4
    Pain
         subjects affected / exposed
    2 / 191 (1.05%)
    3 / 97 (3.09%)
         occurrences all number
    2
    3
    Pyrexia
         subjects affected / exposed
    42 / 191 (21.99%)
    13 / 97 (13.40%)
         occurrences all number
    55
    20
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    13 / 191 (6.81%)
    3 / 97 (3.09%)
         occurrences all number
    13
    3
    Dyspnoea
         subjects affected / exposed
    24 / 191 (12.57%)
    10 / 97 (10.31%)
         occurrences all number
    28
    15
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    6 / 191 (3.14%)
    5 / 97 (5.15%)
         occurrences all number
    6
    7
    Confusional state
         subjects affected / exposed
    6 / 191 (3.14%)
    1 / 97 (1.03%)
         occurrences all number
    6
    1
    Insomnia
         subjects affected / exposed
    9 / 191 (4.71%)
    4 / 97 (4.12%)
         occurrences all number
    11
    5
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 191 (3.66%)
    4 / 97 (4.12%)
         occurrences all number
    11
    6
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 191 (1.57%)
    4 / 97 (4.12%)
         occurrences all number
    6
    6
    Blood alkaline phosphatase increased
         subjects affected / exposed
    6 / 191 (3.14%)
    0 / 97 (0.00%)
         occurrences all number
    8
    0
    Blood bilirubin increased
         subjects affected / exposed
    12 / 191 (6.28%)
    4 / 97 (4.12%)
         occurrences all number
    14
    6
    Lymphocyte count decreased
         subjects affected / exposed
    11 / 191 (5.76%)
    3 / 97 (3.09%)
         occurrences all number
    22
    3
    Neutrophil count decreased
         subjects affected / exposed
    35 / 191 (18.32%)
    14 / 97 (14.43%)
         occurrences all number
    67
    32
    Neutrophil count increased
         subjects affected / exposed
    1 / 191 (0.52%)
    4 / 97 (4.12%)
         occurrences all number
    1
    4
    Platelet count decreased
         subjects affected / exposed
    112 / 191 (58.64%)
    22 / 97 (22.68%)
         occurrences all number
    356
    37
    Weight decreased
         subjects affected / exposed
    12 / 191 (6.28%)
    7 / 97 (7.22%)
         occurrences all number
    14
    7
    White blood cell count decreased
         subjects affected / exposed
    23 / 191 (12.04%)
    5 / 97 (5.15%)
         occurrences all number
    40
    18
    White blood cell count increased
         subjects affected / exposed
    4 / 191 (2.09%)
    4 / 97 (4.12%)
         occurrences all number
    4
    4
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    3 / 191 (1.57%)
    3 / 97 (3.09%)
         occurrences all number
    3
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    11 / 191 (5.76%)
    2 / 97 (2.06%)
         occurrences all number
    16
    2
    Dysgeusia
         subjects affected / exposed
    7 / 191 (3.66%)
    4 / 97 (4.12%)
         occurrences all number
    7
    4
    Headache
         subjects affected / exposed
    7 / 191 (3.66%)
    1 / 97 (1.03%)
         occurrences all number
    7
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    73 / 191 (38.22%)
    23 / 97 (23.71%)
         occurrences all number
    139
    39
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    11 / 191 (5.76%)
    3 / 97 (3.09%)
         occurrences all number
    13
    3
    Abdominal distension
         subjects affected / exposed
    13 / 191 (6.81%)
    2 / 97 (2.06%)
         occurrences all number
    14
    2
    Abdominal pain
         subjects affected / exposed
    53 / 191 (27.75%)
    21 / 97 (21.65%)
         occurrences all number
    74
    23
    Abdominal pain upper
         subjects affected / exposed
    15 / 191 (7.85%)
    5 / 97 (5.15%)
         occurrences all number
    19
    5
    Ascites
         subjects affected / exposed
    24 / 191 (12.57%)
    11 / 97 (11.34%)
         occurrences all number
    27
    12
    Constipation
         subjects affected / exposed
    28 / 191 (14.66%)
    13 / 97 (13.40%)
         occurrences all number
    35
    14
    Diarrhoea
         subjects affected / exposed
    26 / 191 (13.61%)
    14 / 97 (14.43%)
         occurrences all number
    30
    20
    Dry mouth
         subjects affected / exposed
    6 / 191 (3.14%)
    4 / 97 (4.12%)
         occurrences all number
    6
    4
    Dyspepsia
         subjects affected / exposed
    8 / 191 (4.19%)
    1 / 97 (1.03%)
         occurrences all number
    8
    1
    Eructation
         subjects affected / exposed
    0 / 191 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    0
    3
    Nausea
         subjects affected / exposed
    52 / 191 (27.23%)
    23 / 97 (23.71%)
         occurrences all number
    73
    26
    Stomatitis
         subjects affected / exposed
    8 / 191 (4.19%)
    3 / 97 (3.09%)
         occurrences all number
    8
    3
    Vomiting
         subjects affected / exposed
    49 / 191 (25.65%)
    13 / 97 (13.40%)
         occurrences all number
    63
    14
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    7 / 191 (3.66%)
    1 / 97 (1.03%)
         occurrences all number
    7
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 191 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    0
    3
    Night sweats
         subjects affected / exposed
    2 / 191 (1.05%)
    3 / 97 (3.09%)
         occurrences all number
    2
    3
    Pruritus
         subjects affected / exposed
    6 / 191 (3.14%)
    3 / 97 (3.09%)
         occurrences all number
    6
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 191 (0.52%)
    6 / 97 (6.19%)
         occurrences all number
    1
    7
    Back pain
         subjects affected / exposed
    21 / 191 (10.99%)
    9 / 97 (9.28%)
         occurrences all number
    27
    11
    Muscular weakness
         subjects affected / exposed
    6 / 191 (3.14%)
    1 / 97 (1.03%)
         occurrences all number
    8
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    6 / 191 (3.14%)
    1 / 97 (1.03%)
         occurrences all number
    7
    1
    Musculoskeletal pain
         subjects affected / exposed
    10 / 191 (5.24%)
    3 / 97 (3.09%)
         occurrences all number
    11
    3
    Myalgia
         subjects affected / exposed
    6 / 191 (3.14%)
    5 / 97 (5.15%)
         occurrences all number
    6
    5
    Neck pain
         subjects affected / exposed
    2 / 191 (1.05%)
    3 / 97 (3.09%)
         occurrences all number
    2
    3
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    6 / 191 (3.14%)
    2 / 97 (2.06%)
         occurrences all number
    6
    2
    Urinary tract infection
         subjects affected / exposed
    6 / 191 (3.14%)
    3 / 97 (3.09%)
         occurrences all number
    7
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    49 / 191 (25.65%)
    20 / 97 (20.62%)
         occurrences all number
    62
    23
    Dehydration
         subjects affected / exposed
    11 / 191 (5.76%)
    4 / 97 (4.12%)
         occurrences all number
    13
    5
    Hyperglycaemia
         subjects affected / exposed
    8 / 191 (4.19%)
    2 / 97 (2.06%)
         occurrences all number
    12
    2
    Hypokalaemia
         subjects affected / exposed
    6 / 191 (3.14%)
    5 / 97 (5.15%)
         occurrences all number
    7
    5
    Hyponatraemia
         subjects affected / exposed
    6 / 191 (3.14%)
    1 / 97 (1.03%)
         occurrences all number
    7
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Apr 2014
    - Edited inclusion criteria to clarify that qualifying patients should have received at least 2 prior systemic cytotoxic chemotherapy regimens for treatment of unresectable locally advanced or metastatic disease. Clarified that 1 of the prior systemic cytotoxic chemotherapy regimens must have contained gemcitabine and that patients must have met a list of specified criteria regarding the gemcitabine regimen; - Updated dose reduction/delay/discontinuation rules in the event of hematological toxicities, infusion reactions, or other toxicities of various grades, including clarification for reduced dosing, missed doses, coordination of gemcitabine dosing, and gemcitabine toxicity; - Clarified that 2 samples would be collected during the first treatment cycle and a third serum sample for pharmacokinetic assessments was to be collected at baseline for the determination of antibody levels; - Added additional language to describe the preparation and assay of radiolabeled 90Y-clivatuzumab tetraxetan at prescribed doses that exceeded 8 mL in a single 10-mL syringe. These doses would be prepared by using two 10-mL syringes, each adjusted to a final volume of 8 mL, which could be separately assayed and the activities combined; and - Clarified that adverse event (AE) reporting would continue for 30 days (not >30 days) after either the last dose of study drug or until the patient initiated alternative antineoplastic therapy not permitted during this study. Thereafter, AE reporting was to be limited to study drug-related events.
    26 Oct 2015
    - Clarified that during Weeks 2, 3, and 4 of each treatment cycle, the weekly complete blood count should have been obtained prior to the 90Y-clivatuzumab tetraxetan or placebo control dose in order to evaluate for cytopenias that may have required the dose to be reduced, delayed, or discontinued; - Required Karnofsky Performance Status (KPS), patient weight, and the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire evaluations on the fourth week of each treatment cycle in order to obtain additional data for analysis of treatment benefit; - Clarified that randomization was to be stratified on the basis of the number of prior treatments for either unresectable locally advanced or metastatic disease; - Removed wording regarding serum samples collected for determination of PAM4-reactive mucin, since this exploratory analysis was to no longer be performed by the Sponsor; and - Removed inadvertent reference to urinalysis which was not required in this study.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    14 Mar 2016
    The study was stopped due to futility based on the Data and Safety Monitoring Board recommendation.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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.

    European Medicines Agency © 1995-Mon Apr 29 05:01:56 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA