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    Clinical Trial Results:
    An open-label multi-center single agent panobinostat roll-over protocol for patients who have completed a previous Novartis-sponsored panobinostat study and are judged by the investigator to benefit from continued single agent panobinostat treatment

    Summary
    EudraCT number
    		 2012-005252-41
    Trial protocol
    		 ES   NL  
    Global end of trial date
    19 Nov 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    26 Jul 2020
    First version publication date
    18 Dec 2019
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Update to data to align with title of "Percentage..". Number of participants in data changed to percentage of participants.

    Trial information

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    Trial identification
    Sponsor protocol code
    CLBH589B2402B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01802879
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Study Director, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Study Director, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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
    19 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate long term safety data (serious adverse events and adverse events)
    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
    24 Jun 2013
    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
    United States: 4
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Netherlands: 1
    Worldwide total number of subjects
    8
    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)
    5
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 There was no screening period. Patients enrolled into trial directly from the parent protocol.

    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
    		 Panobinostat - 10 to 40 mg/day TIW QoW
    Arm description
    		 10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design
    Arm type
    		 Experimental

    Investigational medicinal product name
    Panobinostat
    Investigational medicinal product code
    LBH589
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    10 - 40 mg/day TIW QoW (three times a week every other week)

    Number of subjects in period 1
    		Panobinostat - 10 to 40 mg/day TIW QoW
    Started
    8
    Completed
    0
    Not completed
    8
         Disease progression
    6
         Administrative problems
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Panobinostat - 10 to 40 mg/day TIW QoW
    Reporting group description
    		 10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design

    Reporting group values
    		 Panobinostat - 10 to 40 mg/day TIW QoW Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 3 3
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54 ± 14.5 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 4 4
        Male
    		 4 4
    Parent protocol participants
    Units: Subjects
        CLBH589B2201
    		 2 2
        CLBH589B2207
    		 3 3
        CLBH589E2214
    		 1 1
        CLBH589X2105
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Panobinostat - 10 to 40 mg/day TIW QoW
    Reporting group description
    		 10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design

    Primary: Overview of adverse events (Safety Set)

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    End point title
    		 Overview of adverse events (Safety Set) [1]
    End point description
    Adverse events were collected from baseline up to 30 days post treatment at scheduled visits. Severity of adverse events was assessed according to the current version of Common Terminology Criteria for Adverse Events (CTCAE). If CTCAE grading did not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, was used
    End point type
    Primary
    End point timeframe
    Baseline up to approximately 60 months
    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: No analysis done
    End point values
    		 Panobinostat - 10 to 40 mg/day TIW QoW
    Number of subjects analysed
    8
    Units: participants
        Any adverse event (AE)
    6
        Any treatment related AE
    2
        Any serious adverse event (SAE)
    2
        Grade 3 or 4 AE
    3
        Grade 3 or 4 AE - suspected to be related
    1
        AEs leading discontinuation
    0
        AEs leading to dose adjust/ temp dose interruption
    2
        On-treatment death
    0
    No statistical analyses for this end point

    Secondary: Percentage of patients with clinical benefit as assessed by the investigator.

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    End point title
    		 Percentage of patients with clinical benefit as assessed by the investigator.
    End point description
    Patients were assessed by investigators at scheduled visits to determine if patient continued to benefit from panobinostat therapy.
    End point type
    Secondary
    End point timeframe
    baseline up to approximately 5 years
    End point values
    		 Panobinostat - 10 to 40 mg/day TIW QoW
    Number of subjects analysed
    8
    Units: Percentage of patients
    number (not applicable)
        Percent of patients with clinical benefit
    87.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 60 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Panobinostat - 10 to 40 mg/day TIW QoW
    Reporting group description
    		 10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design

    Serious adverse events
    		 Panobinostat - 10 to 40 mg/day TIW QoW
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 8 (25.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 8 (12.50%)
         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
    		 Panobinostat - 10 to 40 mg/day TIW QoW
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 8 (50.00%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign muscle neoplasm
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Gastric disorder
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 8 (12.50%)
         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
    11 Mar 2016
    The main purpose of the amendment is to change the primary endpoint to safety to better characterize the long-term safety of the compound. In addition, the protocol has been amended to include the collection of all AEs (including nonserious AEs) and an investigator descriptive attestation of continued clinical benefit (Yes/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.
    None reported
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    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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