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   43871   clinical trials with a EudraCT protocol, of which   7290   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:
    The ReTreatment Trial: A Phase II, open-label, single-arm study of re-treating myelofibrosis patients with ruxolitinib/Jakavi after treatment interruption due to loss of response and/or adverse event.

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines. Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2013-004816-22
    Trial protocol
    		 ES   AT   DE   IT  
    Global end of trial date
    29 Jan 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Aug 2016
    First version publication date
    15 May 2016
    Other versions
    		 v1 (removed from public view)
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CINC424A2407
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02091752
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clincal Disclosure Office, Novartis Pharma AG, 41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the effect of re-treatment with ruxolitinib on reduction in spleen volume of at least 20% from Baseline, by Week 24.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Sep 2014
    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
    Spain: 2
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    1
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients who previously discontinued ruxolitinib due to loss of response and/or AE. Patients were required to have received at least 12 consecutive weeks of treatment with ruxolitinib prior to discontinuation due to AE and/or loss of response were screened to assess their eligibility and enrolled to enter the treatment phase of the trial.

    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
    		 Ruxolitinib
    Arm description
    		 All participants received ruxolitinib.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ruxolitinib
    Investigational medicinal product code
    INC424
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Starting dose was based on reason for previous discontinuation of ruxolitinib (i.e. loss of response or AE) and baseline platelet count. For participants who previously discontinued ruxolitinib due to loss of

    Number of subjects in period 1
    		Ruxolitinib
    Started
    3
    Completed
    0
    Not completed
    3
         Study terminated by Sponsor
    2
         Adverse event, non-fatal
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Ruxolitinib
    Reporting group description
    		 All participants received ruxolitinib.

    Reporting group values
    		 Ruxolitinib Total
    Number of subjects
    		 3 3
    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)
    		 1 1
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 68 ± 9.165 -
    Gender, Male/Female
    Units: Participants
        Female
    		 2 2
        Male
    		 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Ruxolitinib
    Reporting group description
    		 All participants received ruxolitinib.

    Primary: Percentage of patients achieving ≥20% reduction from baseline in spleen volume

    		 Close Top of page
    End point title
    		 Percentage of patients achieving ≥20% reduction from baseline in spleen volume [1]
    End point description
    End point type
    Primary
    End point timeframe
    Week 24
    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: Analysis was not done due to a low number of enrolled participants
    End point values
    		 Ruxolitinib
    Number of subjects analysed
    0 [2]
    Units: percentage of participants
    Notes
    [2] - Analysis was not done due to a low number of enrolled participants.
    No statistical analyses for this end point

    Secondary: Percentage of patients achieving ≥35% reduction from baseline in spleen volume

    		 Close Top of page
    End point title
    		 Percentage of patients achieving ≥35% reduction from baseline in spleen volume
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Ruxolitinib
    Number of subjects analysed
    0 [3]
    Units: percentage of participants
    Notes
    [3] - Analysis was not done due to a low number of enrolled participants.
    No statistical analyses for this end point

    Secondary: Percentage of patients achieving ≥25% and ≥50% reduction, respectively from baseline, in spleen length

    		 Close Top of page
    End point title
    		 Percentage of patients achieving ≥25% and ≥50% reduction, respectively from baseline, in spleen length
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Ruxolitinib
    Number of subjects analysed
    0 [4]
    Units: percentage of participants
    Notes
    [4] - Analysis was not done due to a low number of enrolled participants.
    No statistical analyses for this end point

    Secondary: Percentage of patients achieving ≥25% and ≥50% reduction, respectively, from baseline in total symptom score (MPN-SAF TSS)

    		 Close Top of page
    End point title
    		 Percentage of patients achieving ≥25% and ≥50% reduction, respectively, from baseline in total symptom score (MPN-SAF TSS)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Ruxolitinib
    Number of subjects analysed
    0 [5]
    Units: percentage of participants
    Notes
    [5] - Analysis was not done due to a low number of enrolled participants.
    No statistical analyses for this end point

    Secondary: Change from baseline in spleen length and spleen volume

    		 Close Top of page
    End point title
    		 Change from baseline in spleen length and spleen volume
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Ruxolitinib
    Number of subjects analysed
    0 [6]
    Units: CM
        least squares mean (standard error)
    ±
    Notes
    [6] - Analysis was not done due to a low number of enrolled participants.
    No statistical analyses for this end point

    Secondary: Change from baseline in MPN-SAF TSS score

    		 Close Top of page
    End point title
    		 Change from baseline in MPN-SAF TSS score
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Ruxolitinib
    Number of subjects analysed
    0 [7]
    Units: units on a scale
    Notes
    [7] - Analysis was not done due to a low number of enrolled participants.
    No statistical analyses for this end point

    Secondary: Patient Global Impression of Change (PGIC) score

    		 Close Top of page
    End point title
    		 Patient Global Impression of Change (PGIC) score
    End point description
    End point type
    Secondary
    End point timeframe
    Week 1, Week 24
    End point values
    		 Ruxolitinib
    Number of subjects analysed
    0 [8]
    Units: units on a scale
    Notes
    [8] - Analysis was not done due to a low number of enrolled participants.
    No statistical analyses for this end point

    Secondary: Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQol (EQ)-5D-5L scores

    		 Close Top of page
    End point title
    		 Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQol (EQ)-5D-5L scores
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1, Week 8, Week 12, Week 16, Week 24
    End point values
    		 Ruxolitinib
    Number of subjects analysed
    0 [9]
    Units: units on a scale
    Notes
    [9] - Analysis was not done due to a low number of enrolled participants.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Ruxolitinib
    Reporting group description
    		 All participants received ruxolitinib.

    Serious adverse events
    		 Ruxolitinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Immune system disorders
    CYTOKINE RELEASE SYNDROME
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    RENAL FAILURE
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    LISTERIOSIS
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ruxolitinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    7
    Gastrointestinal disorders
    ANAL HAEMORRHAGE
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    ASCITES
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    CONSTIPATION
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    DIARRHOEA
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    VARICES OESOPHAGEAL
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Hepatobiliary disorders
    PORTAL VEIN THROMBOSIS
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    CYSTITIS
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated due to low enrollment. No analysis was done due to low enrollment.
    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-Fri May 03 21:23:05 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA