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    Clinical Trial Results:
    Randomised, phase III multicenter, open study of lanreotide in non metastatic castration-resistant prostate cancer patients presenting elevated Chromogranin A levels

    Summary
    EudraCT number
    2010-019862-10
    Trial protocol
    IT  
    Global end of trial date
    25 Jun 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    27 Feb 2016
    First version publication date
    12 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review and correction

    Trial information

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    Trial identification
    Sponsor protocol code
    A 93-52030-738
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01313273
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ipsen
    Sponsor organisation address
    Via Del Bosco Rinnovato, 6, Assago - Milano, Italy, 20090
    Public contact
    Medical Director, Oncology, Ipsen, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Oncology, Ipsen, clinical.trials@ipsen.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
    01 Sep 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the efficacy in terms of Progression-free survival (PFS) of the administration of non steroidal anti androgens and LHRH-a (Arm A) versus lanreotide in addition to non steroidal anti androgens and LHRH-a (Arm B) as second line approach in non metastatic prostate cancer patients with castrate resistant disease and elevated CgA circulating levels. According to the updated guidelines of the PCWG2 Progression-free survival (PFS) will be considered a composite end point defined as the time from random assignment to disease progression in bone or soft-tissue, symptoms, or death.A rising PSA alone will not be considered an indicator of disease progression since radiographic or symptomatic progression better reflect changes in clinical status.Subjects stopping the study for any reason, including isolated PSA increase, will be censored at their last date of evaluation.Patients without tumor progression or death at the time of analysis will be censored at their last date of evaluation
    Protection of trial subjects
    The Sponsor is responsible for monitoring this data to verify that the rights and well being of subjects are protected and that the trial is conducted in compliance with the protocol, GCP and regulatory requirements. Lanreotide has been proven to be effective in reducing plasma CgA levels. All those evidence, support exploring the antineoplastic activity and efficacy of lanreotide in patients with progressive disease to first line hormonal treatment and eligible for second line hormone therapy (castration resistant patients) .
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Jun 2011
    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
    Italy: 3
    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)
    2
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects ≥18 years meeting inclusion criteria were recruited for this study.

    Pre-assignment
    Screening details
    Investigators screened 8 subjects. Randomized 3 subjects and 5 were not randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm A : Non-steroidal Anti Androgens + LHRH-a
    Arm description
    Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.
    Arm type
    Experimental

    Investigational medicinal product name
    Second line hormonal treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Submucosal use
    Dosage and administration details
    Luteinizing hormone-releasing hormone analogues (LHRH-a) ± Anti androgen were administered until the date of disease progression

    Arm title
    Arm B : Lanreotide + Non Steroidal Anti Androgens and LHRH-a
    Arm description
    Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
    Arm type
    Experimental

    Investigational medicinal product name
    Second line hormonal treatment + lanreotide 120 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lanreotide, non steroidal anti androgens and LHRH-a to be administered till progression or for a maximum of 24 months.

    Number of subjects in period 1
    Arm A : Non-steroidal Anti Androgens + LHRH-a Arm B : Lanreotide + Non Steroidal Anti Androgens and LHRH-a
    Started
    2
    1
    Completed
    0
    0
    Not completed
    2
    1
         Screening Chromogranin A-in normal range
    -
    1
         Withdrawal by Subject
    1
    -
         INCLUSION CRITERIA 4 NOT RESPECTED
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A : Non-steroidal Anti Androgens + LHRH-a
    Reporting group description
    Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.

    Reporting group title
    Arm B : Lanreotide + Non Steroidal Anti Androgens and LHRH-a
    Reporting group description
    Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.

    Reporting group values
    Arm A : Non-steroidal Anti Androgens + LHRH-a Arm B : Lanreotide + Non Steroidal Anti Androgens and LHRH-a Total
    Number of subjects
    2 1 3
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    1 1 2
        From 65-84 years
    1 0 1
        85 years and over
    0 0 0
    Age continuous
    Value of age continuous, for total participants is 61.00 (57.00 to 84.00).
    Units: years
        median (full range (min-max))
    72.5 (61 to 84) 57 (57 to 57) -
    Gender categorical
    Units: Subjects
        Female
    0 0 0
        Male
    2 1 3
    Region of Enrollment
    Units: Subjects
        Italy
    2 1 3

    End points

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    End points reporting groups
    Reporting group title
    Arm A : Non-steroidal Anti Androgens + LHRH-a
    Reporting group description
    Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.

    Reporting group title
    Arm B : Lanreotide + Non Steroidal Anti Androgens and LHRH-a
    Reporting group description
    Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.

    Primary: Progression-free Survival

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    End point title
    Progression-free Survival [1]
    End point description
    Study early terminated due to poor enrollment.
    End point type
    Primary
    End point timeframe
    Week 96
    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 statistical details provided.
    End point values
    Arm A : Non-steroidal Anti Androgens + LHRH-a Arm B : Lanreotide + Non Steroidal Anti Androgens and LHRH-a
    Number of subjects analysed
    2
    1
    Units: Participants
        Number of Participants Analyzed
    0
    0
    No statistical analyses for this end point

    Secondary: Prostate Specific Antigen (PSA) Response

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    End point title
    Prostate Specific Antigen (PSA) Response
    End point description
    Study early terminated due to poor enrollment.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    Arm A : Non-steroidal Anti Androgens + LHRH-a Arm B : Lanreotide + Non Steroidal Anti Androgens and LHRH-a
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Participants
    Notes
    [2] - Study early terminated due to poor enrollment
    [3] - Study early terminated due to poor enrollment
    No statistical analyses for this end point

    Secondary: Median Time to PSA Response

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    End point title
    Median Time to PSA Response
    End point description
    Study early terminated due to poor enrollment.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    Arm A : Non-steroidal Anti Androgens + LHRH-a Arm B : Lanreotide + Non Steroidal Anti Androgens and LHRH-a
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Participants
    Notes
    [4] - Study early terminated due to poor enrollment
    [5] - Study early terminated due to poor enrollment
    No statistical analyses for this end point

    Secondary: Reduction in Chromogranin A Serum Levels

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    End point title
    Reduction in Chromogranin A Serum Levels
    End point description
    Study early terminated due to poor enrollment
    End point type
    Secondary
    End point timeframe
    Baseline, Week 96
    End point values
    Arm A : Non-steroidal Anti Androgens + LHRH-a Arm B : Lanreotide + Non Steroidal Anti Androgens and LHRH-a
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Participants
    Notes
    [6] - Study early terminated due to poor enrollment
    [7] - Study early terminated due to poor enrollment
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were reported from Baseline (visit 2) to visit 10 (Week 96 - End of study)
    Adverse event reporting additional description
    All AEs documented for this study were treatment emergent. Overall, for 1 patient (100.0%) of Arm B at least one AE, at least one AE related to study treatment and at least one severe AE were reported.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Arm A : Non-steroidal Anti Androgens + LHRH-a
    Reporting group description
    -

    Reporting group title
    Arm B : Lanreotide + Non-steroidal Antiandrogens and LHRH-a
    Reporting group description
    -

    Serious adverse events
    Arm A : Non-steroidal Anti Androgens + LHRH-a Arm B : Lanreotide + Non-steroidal Antiandrogens and LHRH-a
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Arm A : Non-steroidal Anti Androgens + LHRH-a Arm B : Lanreotide + Non-steroidal Antiandrogens and LHRH-a
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
    Investigations
    Transaminases increased
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Oct 2011
    - Inclusion of patients with stable metastatic disease and exclusion of the non metastatic patients (this required the change in study title) - Inclusion of patients already treated with maximal androgen blockade (MAB) i.e. LHRHa + antiandrogen. This modified also the study design: to evaluate the efficacy in terms of PFS of the administration of second – line hormonal treatment (Arm A) versus second - line hormonal treatment + lanreotide (Arm B) (based on the definition of “second-line hormonal therapy” according to Italian guidelines - AIOM / Prostate Cancer 11-2009) - The inclusion criterion relative to the serum creatinine was modified (new cutoff <1.5xULN) - In order to avoid possible bias due to different type of treatment of patient at inclusion (MAB or LHRHa alone), a new randomization list has been generated to account for stratification by type of treatment at inclusion - Inclusion of patients with stable metastatic disease besides the non metastatic patients already required in the main protocol (this required the change in study title) - Exclusion of patients with visceral metastasis and patients taking narcotic for analgesia for bone pain. This was introduced to avoid the enrolment of patients with an high stage disease which could require anticancer therapy

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    12 Nov 2012
    Study terminated due to poor enrollment.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Study terminated due to poor enrollment
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