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    Clinical Trial Results:
    A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PROOF OF CONCEPT STUDY OF MAINTENANCE THERAPY WITH TASQUINIMOD IN PATIENTS WITH METASTATIC CASTRATE-RESISTANT PROSTATE CANCER WHO ARE NOT PROGRESSING AFTER A FIRST LINE DOCETAXEL BASED CHEMOTHERAPY

    Summary
    EudraCT number
    		 2012-001038-32
    Trial protocol
    		 ES   BE   CZ   LT   HU   IT   DK   GB   DE   PL  
    Global end of trial date
    20 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2016
    First version publication date
    13 May 2016
    Other versions
    Summary report(s)
    		 AE details

    Trial information

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    Trial identification
    Sponsor protocol code
    8-55-58102-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma
    Sponsor organisation address
    65 quai Georges Gorse, Boulogne-Billancourt, France, 92100
    Public contact
    Medical director, Department of Cancer Medicine, Ipsen Pharma, clinical.trials@ipsen.com
    Scientific contact
    Medical director, Department of Cancer Medicine, Ipsen Pharma, 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
    07 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the clinical efficacy (i.e. radiological progression free survival [PFS]) of tasquinimod maintenance therapy with placebo in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have not progressed after a first line docetaxel based chemotherapy.
    Protection of trial subjects
    This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonisation (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21 and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 7
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    Denmark: 19
    Country: Number of subjects enrolled
    France: 31
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Lithuania: 17
    Worldwide total number of subjects
    144
    EEA total number of subjects
    144
    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)
    28
    From 65 to 84 years
    115
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was performed as a multicentre study at 51 investigational sites (of which 44 randomised patients) in Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Lithuania, Poland, Spain and United Kingdom (UK).

    Pre-assignment
    Screening details
    		 A total of 219 patients were screened and 144 patients were randomised.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    All of the study treatments were similar in size, colour, smell, taste and appearance allowing the blinded conditions of the study to be maintained.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tasquinimod
    Arm description
    		 1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression. Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose Withdrawn during treatment period 59 (AE 13, Consent withdrawn 13, Disease progression 31, Other 2)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    tasquinimod
    Investigational medicinal product code
    ABR-215050
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    0.25 to 1 mg

    Arm title
    		 Placebo
    Arm description
    		 1 capsule daily, taken orally with water and food until disease progression Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food. Withdrawn during treatment period 61 (AE 3, Consent withdrawn 6, Disease progression 46, Other 6)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    0 mg

    Number of subjects in period 1
    		Tasquinimod Placebo
    Started
    71
    73
    Ongoing in Treatment Period:Data Cut-off
    12
    12
    Withdrawn During Treatment:Data Cut-off
    59
    61
    Ongoing Treatment Period:Final Analysis
    0
    0
    Withdrawn During Treatment:Final Analysi
    71
    73
    Completed
    0
    0
    Not completed
    71
    73
         Consent withdrawn by subject
    13
    6
         Disease progression
    37
    50
         Adverse event, non-fatal
    13
    3
         Not Specified
    8
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tasquinimod
    Reporting group description
    		 1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression. Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose Withdrawn during treatment period 59 (AE 13, Consent withdrawn 13, Disease progression 31, Other 2)

    Reporting group title
    Placebo
    Reporting group description
    		 1 capsule daily, taken orally with water and food until disease progression Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food. Withdrawn during treatment period 61 (AE 3, Consent withdrawn 6, Disease progression 46, Other 6)

    Reporting group values
    		 Tasquinimod Placebo Total
    Number of subjects
    		 71 73 144
    Age categorical
    Units: Subjects
        18 to ≤ 65 years
    		 18 17 35
        66 to ≤ 75 years
    		 40 45 85
        > 75 years
    		 13 11 24
    Age continuous
    ITT population: All randomised patients. Patients were allocated to the treatment they were randomised to. Patients randomised that have been actually dead before randomisation were not retained in the intention to treat (ITT) population
    Units: years
        arithmetic mean (standard deviation)
    		 69.6 ( 7.18 ) 69.6 ( 5.57 ) -
    Gender categorical
    ITT population: All randomised patients. Patients were allocated to the treatment they were randomised to. Patients randomised that have been actually dead before randomisation were not retained in the intention to treat (ITT) population
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 71 73 144
    Race
    ITT population: All randomised patients. Patients were allocated to the treatment they were randomised to. Patients randomised that have been actually dead before randomisation were not retained in the intention to treat (ITT) population.
    Units: Subjects
        Black/African American
    		 0 1 1
        Caucasian/White
    		 52 58 110
        Multiple Race
    		 1 0 1
        Missing
    		 18 14 32
    Region of Enrollment
    ITT population: All randomised patients. Patients were allocated to the treatment they were randomised to. Patients randomised that have been actually dead before randomisation were not retained in the intention to treat (ITT) population
    Units: Subjects
        Czech Republic
    		 5 1 6
        Belgium
    		 5 6 11
        Hungary
    		 2 2 4
        Denmark
    		 6 13 19
        Poland
    		 4 3 7
        Italy
    		 9 5 14
        United Kingdom
    		 8 6 14
        France
    		 17 14 31
        Lithuania
    		 7 10 17
        Germany
    		 3 3 6
        Spain
    		 5 10 15
    Ethnicity
    ITT population: All randomised patients. Patients were allocated to the treatment they were randomised to. Patients randomised that have been actually dead before randomisation were not retained in the intention to treat (ITT) population
    Units: Subjects
        Hispanic or Latino
    		 2 4 6
        Not Hispanic or Latino
    		 52 55 107
        Missing
    		 17 14 31
    ECOG Performance Status Score
    ITT population Eastern Co-operative Oncology Group (ECOG) Score: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity, but ambulatory & able to carry out work of a light or sedentary nature, e.g. light house work, office work, 2=Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours, 3=Capable of limited self-care,confined to bed or chair more than 50% of waking hours, 4=Completely disabled. Totally confined to bed or chair, 5=Dead
    Units: Subjects
        0 (Normal Activity)
    		 39 31 70
        1 (Restricted Activity)
    		 32 38 70
        Missing
    		 0 4 4
    Region
    ITT population: All randomised patients. Patients were allocated to the treatment they were randomised to. Patients randomised that have been actually dead before randomisation were not retained in the intention to treat (ITT) population.
    Units: Subjects
        Eastern Europe
    		 18 16 34
        Western Europe
    		 53 57 110
    Weight
    ITT population: All randomised patients. Patients were allocated to the treatment they were randomised to. Patients randomised that have been actually dead before randomisation were not retained in the intention to treat (ITT) population.
    Units: kg
        arithmetic mean (standard deviation)
    		 83.7 ( 12.57 ) 83.4 ( 15.09 ) -
    BMI
    ITT population: All randomised patients. Patients were allocated to the treatment they were randomised to. Patients randomised that have been actually dead before randomisation were not retained in the intention to treat (ITT) population.
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.67 ( 3.543 ) 28.01 ( 4.399 ) -

    End points

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    End points reporting groups
    Reporting group title
    Tasquinimod
    Reporting group description
    		 1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression. Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose Withdrawn during treatment period 59 (AE 13, Consent withdrawn 13, Disease progression 31, Other 2)

    Reporting group title
    Placebo
    Reporting group description
    		 1 capsule daily, taken orally with water and food until disease progression Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food. Withdrawn during treatment period 61 (AE 3, Consent withdrawn 6, Disease progression 46, Other 6)

    Primary: Time to Radiological Progression Free Survival [PFS]

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    End point title
    		 Time to Radiological Progression Free Survival [PFS]
    End point description
    The time from the date of randomisation to the date of radiological progression or death due to any cause. Intention to treat (ITT) Population
    End point type
    Primary
    End point timeframe
    Every 8 weeks until disease progression documentation (approximately up to 2.5 years)
    End point values
    		 Tasquinimod Placebo
    Number of subjects analysed
    71
    73
    Units: Weeks
        median (confidence interval 90%)
    31.7 (24.3 to 53.7)
    22.7 (16.1 to 25.9)
    Statistical analysis title
    		 Stratified[a]
    Statistical analysis description
    ITT Population
    Comparison groups
    Tasquinimod v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0315 [1]
    Method
    		 Logrank
    Confidence interval
    Notes
    [1] - Adjusted for visceral metastases, opioid analgesic use and region, demonstrating a reduction in the risk of progression of 40% for tasquinimod compared with placebo Method
    Statistical analysis title
    		 Unstratified[b]
    Statistical analysis description
    ITT Population
    Comparison groups
    Tasquinimod v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0344
    Method
    		 Logrank
    Confidence interval

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival is defined as the time from randomisation to death due to any cause. ITT Population Tasquinimod: The data for this outcome is not evaluable (NE), listed as 0. Median (90% Confidence Interval)= (NE to NE). Patients censored = 63, Patients at risk (t=0) = 71. Overall survival data are immature: only 8 deaths are reported Placebo: The data for this outcome is not evaluable (NE), listed as 0. Median (90% Confidence Interval)= (NE to NE). Patients censored = 67, Patients at risk (t=0) = 73. Overall survival data are immature: only 6 deaths are reported
    End point type
    Secondary
    End point timeframe
    Every 3 months after study treatment stop until death (approximately up to 2.5 years)
    End point values
    		 Tasquinimod Placebo
    Number of subjects analysed
    71
    73
    Units: weeks
        number (not applicable)
    0
    0
    Statistical analysis title
    		 Stratified[a]
    Statistical analysis description
    ITT Population
    Comparison groups
    Tasquinimod v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.443 [2]
    Method
    		 Logrank
    Confidence interval
    Notes
    [2] - Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value

    Secondary: Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2)

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    End point title
    		 Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2)
    End point description
    The time from the date of randomisation to the date of radiological progression free survival [PFS] on next-line therapy (PFS 2) or death due to any cause. ITT Population Tasquinimod: Median (90% Confidence Interval)= (7.1 to 30.7). Patients censored = 28, Patients at risk (t=0) = 39. Placebo: Median (90% Confidence Interval)= (12.6 to NA). Patients censored = 44, Patients at risk (t=0) = 47
    End point type
    Secondary
    End point timeframe
    Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years)
    End point values
    		 Tasquinimod Placebo
    Number of subjects analysed
    71
    73
    Units: weeks
        number (not applicable)
    19.3
    24.1
    Statistical analysis title
    		 PFS 2
    Statistical analysis description
    ITT Population
    Comparison groups
    Tasquinimod v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5219 [3]
    Method
    		 Logrank
    Confidence interval
    Notes
    [3] - Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value

    Secondary: Symptomatic PFS

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    End point title
    		 Symptomatic PFS
    End point description
    Symptomatic PFS is defined as the time from the date of randomisation to the date of symptomatic progression or death due to prostate cancer, whichever occurs first [symptomatic progression as assessed by Brief Pain Inventory (BPI) and analgesic use] ITT Population Tasquinimod: The data for this outcome is not evaluable (NE), listed as 0. Median (90% Confidence Interval)= (31.9 to NE). Patients censored = 48, Patients at risk (t=0) = 71 Placebo: The data for Median (90% Confidence Interval), is NE (Not evaluable). Patients censored = 54, Patients at risk (t=0) = 73
    End point type
    Secondary
    End point timeframe
    Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years)
    End point values
    		 Tasquinimod Placebo
    Number of subjects analysed
    71
    73
    Units: weeks
        number (not applicable)
    0
    95.3
    Statistical analysis title
    		 Symptomatic PFS
    Statistical analysis description
    ITT Population
    Comparison groups
    Tasquinimod v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5442 [4]
    Method
    		 Logrank
    Confidence interval
    Notes
    [4] - Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value

    Secondary: Time to Further Anticancer Treatment for Prostate Cancer

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    End point title
    		 Time to Further Anticancer Treatment for Prostate Cancer
    End point description
    Time from randomisation to further treatment for prostate cancer ITT population
    End point type
    Secondary
    End point timeframe
    Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years)
    End point values
    		 Tasquinimod Placebo
    Number of subjects analysed
    71
    73
    Units: weeks
        median (confidence interval 90%)
    42.3 (32 to 58)
    29 (23.1 to 39.1)
    Statistical analysis title
    		 Time to Further Anticancer Treatment for Prostate
    Statistical analysis description
    ITT Population
    Comparison groups
    Tasquinimod v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.112 [5]
    Method
    		 Logrank
    Confidence interval
    Notes
    [5] - Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value

    Secondary: Time to Deterioration in Functional Assessment of Cancer Therapy – Prostate (FACT-P)

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    End point title
    		 Time to Deterioration in Functional Assessment of Cancer Therapy – Prostate (FACT-P)
    End point description
    End of Study visit (within 14 days of last dose of study treatment) Impact of tasquinimod on health related quality of life (QoL) - Analysis of time to deterioration in FACT-P The FACT-P measurement system is a validated collection of health related quality of life (HRQOL) questionnaires used to assess HRQOL in men with prostate cancer. It is appropriate for use with patients with any form of cancer and extensions of it have been used and validated in other chronic illness condition. The FACT-P is a self-administered 39-item scale comprising five domains: physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns. The individual subscale scores range from 0 to a high between 24 and 48 and the total score ranges between 0 and 156, with higher scores representing better Quality of Life (QoL) ITT Population
    End point type
    Secondary
    End point timeframe
    Up to End of Study visit (approximately up to 2.5 years)
    End point values
    		 Tasquinimod Placebo
    Number of subjects analysed
    71
    73
    Units: weeks
        median (confidence interval 90%)
    8.1 (8.1 to 13.1)
    15.7 (10.6 to 16.3)
    Statistical analysis title
    		 Stratified[a]
    Statistical analysis description
    ITT Population
    Comparison groups
    Tasquinimod v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2491 [6]
    Method
    		 Logrank
    Confidence interval
    Notes
    [6] - Comments Adjusting for presence (or absence) of visceral metastases, opioid analgesic use (or not) & region (Eastern Europe, Western Europe). One-sided p-value

    Secondary: Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score

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    End point title
    		 Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score
    End point description
    Baseline is defined as the last measurement collected prior to the first dose of study drug. End of Study visit (within 14 days of last dose of study treatment) The EQ-5D, a 5-item scale useful in health resource utilisation and cost comparisons between the treatment groups designed for self-completion by patients consists of two pages [EQ-5 descriptive system and EQ Visual Analogue Scale (VAS)]. The EQ-5 descriptive system comprises five dimensions: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels: no problems, some problems, severe problems. The EQ-VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled "Best imaginable health state" and "Worst imaginable health state" ITT population
    End point type
    Secondary
    End point timeframe
    Baseline and End-of-study Visit (approximately up to 2.5 years)
    End point values
    		 Tasquinimod Placebo
    Number of subjects analysed
    39
    50
    Units: Units on scale
        median (inter-quartile range (Q1-Q3))
    -9 (-74 to 63)
    -3.5 (-55 to 30)
    No statistical analyses for this end point

    Secondary: Safety Profile of Tasquinimod

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    End point title
    		 Safety Profile of Tasquinimod
    End point description
    Number of subjects reporting adverse events Safety Population: All patients who received at least one dose of study treatment. Patients were allocated to the treatment they actually received
    End point type
    Secondary
    End point timeframe
    At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)
    End point values
    		 Tasquinimod Placebo
    Number of subjects analysed
    71
    70
    Units: Participants
        Any Treatment Emergent Adverse Event (TEAEs)
    69
    66
        Intensity of TEAEs [Grade 3-5 (severe)]
    36
    19
        Intensity of TEAEs [Grade 5]
    1
    3
        Intensity of TEAEs [Grade 4]
    3
    2
        Intensity of TEAEs [Grade 3]
    32
    14
        Intensity of TEAEs [Grade 2 (moderate)]
    28
    28
        Intensity of TEAEs [Grade 1 (mild)]
    5
    19
        Causality of TEAEs [Drug Related]
    54
    38
        Causality of TEAEs [Not Drug Related]
    15
    28
        TEAEs Leading to Drug Withdrawal
    12
    3
        TEAEs leading to Dose Reduction
    16
    2
        TEAEs leading to Drug Interruption
    33
    12
        TEAEs Leading to Death
    1
    0
        Serious Adverse Event (SAEs)
    24
    16
        Drug Related SAEs
    6
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Tasquinimod
    Reporting group description
    		 1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression. Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose Withdrawn during treatment period 59 (AE 13, Consent withdrawn 13, Disease progression 31, Other 2)

    Reporting group title
    Placebo
    Reporting group description
    		 1 capsule daily, taken orally with water and food until disease progression Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food. Withdrawn during treatment period 61 (AE 3, Consent withdrawn 6, Disease progression 46, Other 6)

    Serious adverse events
    		 Tasquinimod Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (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: 5%
    Non-serious adverse events
    		 Tasquinimod Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Details of SAE and common (incidence >5%) TEAEs has been attached as an appendix, since there are no occurence details available.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 May 2013
    • Change in Inclusion Criteria concerning the cumulative rather than starting dose of docetaxel and consideration of PSA measurements, including addition of a fourth measurement in certain circumstances. • Change in Exclusion Criterion by addition of history of venous thrombo embolic disease. • Clarification of statistical analysis. • A definition of visceral metastases has been added. • Tumour assessment follow-up for radiological progression has been clarified. • A list of disallowed foods were added due to their inhibitory effect on the activity of CYP 3A4. • Clarification of laboratory abnormalities that had to be reported as AEs. • Administrative changes, correction of typographical errors and alignment of sample collection times to be in accordance with the Schedule of Assessments.

    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 early due to the stop of the project as decided by sponsor. The trial included number of planned patients & number of events(PFS)were met to draw conclusions. Only follow-up of patients were discontinued earlier than planned.
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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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