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    Clinical Trial Results:
    A Phase II Study of PM01183 as Second-line Treatment in Patients with Metastatic Pancreatic Cancer.

    Summary
    EudraCT number
    2010-024292-30
    Trial protocol
    GB   ES  
    Global end of trial date
    28 Nov 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PM1183-B-001-10
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pharma Mar, S.A.
    Sponsor organisation address
    Avenida de los Reyes, 1 Polígono Industrial La Mina-Norte, Colmenar Viejo, Madrid, Spain, 28770
    Public contact
    Clinical Development Department of PharmaMar´s Oncology, Business Unit., Pharma Mar, S.A., +34 918466000, clinicaltrials@pharmamar.com
    Scientific contact
    Clinical Development Department of PharmaMar´s Oncology, Business Unit., Pharma Mar, S.A., +34 918466000, clinicaltrials@pharmamar.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
    18 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the antitumor activity of PM01183 in terms of overall survival rate at 6 months (OS6) in patients with metastatic pancreatic cancer.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and was consistent with the Good Clinical Practice (GCP) and applicable regulatory requirements. Study personnel involved in conducting this trial was qualified by education, training, and experience to perform their respective task(s). The Sponsor provided insurance or indemnity in accordance with the applicable regulatory requirements.
    Background therapy
    All patients had to receive standard prophylactic medication at least 30 minutes before the administration of PM01183, as follows: • Corticosteroids (dexamethasone 8 mg i.v. or equivalent) • Serotonin (5-HT3) antagonists (ondansetron 8 mg i.v. or equivalent)
    Evidence for comparator
    -
    Actual start date of recruitment
    29 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
    Spain: 33
    Country: Number of subjects enrolled
    United Kingdom: 12
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    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)
    26
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 45 patients were enrolled at seven investigational sites, and 44 of them were treated with PM01183. The patients participated in this study between 29 June 2011 (first consent) and 28 November 2013 (last follow-up). First and last infusions were administered on 11 July 2011 and 3 July 2013, respectively

    Pre-assignment
    Screening details
    Voluntary written IC, 18-75 years, Histologically/cytologically confirmed cancer of the exocrine pancreas, Stage IV disease, Patient had to have progressed during or after one prior line of gemcitabine based therapy, ECOG PS ≤ 1, Adequate hematological, renal, metabolic and hepatic function, At least two weeks since last prior therapy

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    PM01183
    Arm description
    PM01183 was given at a dose of 7.0 mg FD as a 1-hour q3wk i.v. infusion. Each cycle lasted three weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    PM01183
    Investigational medicinal product code
    PM01183
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    PM01183 was given at a dose of 7.0 mg FD as a 1-hour q3wk i.v. infusion. Each cycle lasted three weeks

    Number of subjects in period 1
    PM01183
    Started
    45
    Treated
    44
    Completed
    0
    Not completed
    45
         Progressive disease
             30
         Physician decision
             1
         Clinical progression
             2
         Adverse event, serious fatal
             3
         Adverse event, non-fatal
             1
         Consent withdrawn by subject
             1
         Clinical deterioration
             1
         Death due to malignant disease
             5
         Not treated
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    -

    Reporting group values
    Overall period Total
    Number of subjects
    45 45
    Age categorical
    Units: Subjects
        18-49 years
    2 2
        50-69 years
    36 36
        >=70 years
    7 7
    Age continuous
    Units: years
        median (full range (min-max))
    62 (42 to 83) -
    Gender categorical
    Units: Subjects
        Female
    32 32
        Male
    13 13
    Race
    Units: Subjects
        Caucasian
    42 42
        Black
    1 1
        Arabic
    2 2
    ECOG
    Eastern Cooperative Oncology Group performance status
    Units: Subjects
        PS 0
    8 8
        PS 1
    37 37
    Elevated CA19-9
    Units: Subjects
        Yes
    41 41
        No
    4 4
    Pain control medication
    Units: Subjects
        Fully controlled
    9 9
        Controlled most of the time
    19 19
        Controlled < 50% of time
    3 3
        No
    14 14
    Opioid consumption
    Units: Subjects
        Yes
    16 16
        No
    29 29
    Primary tumor location (pancreas)
    Units: Subjects
        Head
    28 28
        Body/tail
    16 16
        Head + body/tail
    1 1
    Tumor stage at diagnosis
    Units: Subjects
        Metastatic
    23 23
        Locally advanced
    17 17
        Early
    5 5
    Histology grade
    Units: Subjects
        Well differentiated
    4 4
        Moderately differentiated
    11 11
        Poorly differentiated
    7 7
        UK
    23 23
    Current disease (metastatic)
    Units: Subjects
        Visceral
    19 19
        Ganglionar/Peritoneal
    8 8
        Both
    18 18
    No. of sites of disease
    Units: Subjects
        1 site
    10 10
        2 sites
    19 19
        3 sites
    10 10
        4 sites
    5 5
        8 sites
    1 1
    Chemoradiotherapy
    Units: Subjects
        Yes
    7 7
        No
    38 38
    Surgery
    Units: Subjects
        Yes
    24 24
        No
    21 21
    Setting of Chemotherapy
    Units: Subjects
        Advanced
    34 34
        Adjuvant
    9 9
        Adjuvant+advanced
    2 2
    Most frequent prior chemotherapy regimens
    Units: Subjects
        Gemcitabine
    15 15
        Gemcitabine + capecitabine
    8 8
        Gemcitabine + oxaliplatin
    8 8
        Gemcitabine + paclitaxel
    4 4
        Gemcitabine + 5-FU
    3 3
        Gemcitabine + Others
    7 7
    Best response to last prior chemotherapy
    Units: Subjects
        PR
    4 4
        SD
    15 15
        PD
    10 10
        NA
    5 5
        UK
    11 11
    Signs and symptoms
    Units: Subjects
        0 sign/symptom
    8 8
        1 sign/symptom
    16 16
        2 signs/symptoms
    10 10
        3 signs/symptoms
    6 6
        4 signs/symptoms
    4 4
        5 signs/symptoms
    1 1
    Physical examination
    Units: Subjects
        Normal
    41 41
        Abnormal
    4 4
    ECG
    Electrocardiogram
    Units: Subjects
        Normal
    32 32
        Abnormal
    13 13
    LVEF
    left ventricular ejection fraction
    Units: Subjects
        Normal
    44 44
        Abnormal
    1 1
    BSA
    body surface area
    Units: m2
        median (full range (min-max))
    1.76 (1.29 to 2.44) -
    Albumin
    Units: g/dl
        median (full range (min-max))
    3.9 (2.6 to 4.9) -
    CA19-9
    Units: IU/l
        median (full range (min-max))
    1965 (0.6 to 153230) -
    Time from diagnosis to first PM01183 infusion
    Units: months
        median (full range (min-max))
    7.3 (2.5 to 34.8) -
    Time from last disease progression before study entry to first PM01183 infusion
    Units: months
        median (full range (min-max))
    0.7 (0.1 to 11.1) -
    No. of sites of disease
    Units: sites
        median (full range (min-max))
    2 (1 to 8) -
    No. of agents of Chemotherapy
    Units: No. of agents
        median (full range (min-max))
    2 (1 to 3) -
    TTP to last prior advanced chemotherapy
    Units: months
        median (full range (min-max))
    4.6 (1.4 to 23.4) -
    Signs and symptoms
    Units: signs and symptoms
        median (full range (min-max))
    1 (0 to 5) -
    Weight
    Units: kilogram(s)
        median (full range (min-max))
    68.7 (38.5 to 113.5) -
    Height
    Units: cm
        median (full range (min-max))
    168 (151 to 193) -
    BMI
    body mass index
    Units: kg/m2
        median (full range (min-max))
    24.1 (16.9 to 36.8) -
    WBC
    Units: x10^9/l
        median (full range (min-max))
    6.8 (3.3 to 15.7) -
    Hemoglobin
    Units: g/dl
        median (full range (min-max))
    12.1 (9.5 to 14.9) -
    Platelets
    Units: x10^9/l
        median (full range (min-max))
    248 (110 to 571) -
    Neutrophils
    Units: x10^9/l
        median (full range (min-max))
    4.1 (1.7 to 12.2) -
    Lymphocytes
    Units: x10^9/l
        median (full range (min-max))
    1.5 (0.6 to 4) -
    ALT
    Units: xULN
        median (full range (min-max))
    0.6 (0.2 to 2.8) -
    AP
    Units: xULN
        median (full range (min-max))
    1.2 (0.4 to 3.8) -
    AST
    Units: xULN
        median (full range (min-max))
    0.7 (0.4 to 3.7) -
    CPK
    Units: xULN
        median (full range (min-max))
    0.3 (0.1 to 1.9) -
    Creatinine
    Units: xULN
        median (full range (min-max))
    0.6 (0.4 to 1) -
    GGT
    Units: xULN
        median (full range (min-max))
    1.4 (0.3 to 21.6) -
    Total bilirubin
    Units: xULN
        median (full range (min-max))
    0.5 (0.2 to 1.7) -
    Calcium
    Units: mmol/l
        median (full range (min-max))
    2.3 (2.1 to 2.7) -
    Potassium
    Units: mmol/l
        median (full range (min-max))
    4.2 (3.6 to 5.3) -
    Sodium
    Units: mmol/l
        median (full range (min-max))
    139 (127 to 144.5) -
    Total cholesterol
    Units: mg/dl
        median (full range (min-max))
    177.9 (85 to 249) -

    End points

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    End points reporting groups
    Reporting group title
    PM01183
    Reporting group description
    PM01183 was given at a dose of 7.0 mg FD as a 1-hour q3wk i.v. infusion. Each cycle lasted three weeks.

    Primary: Overall Survival Rate at Six Months

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    End point title
    Overall Survival Rate at Six Months [1]
    End point description
    End point type
    Primary
    End point timeframe
    Six months after the first PM01183 dose of each patient
    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: Primary endpoint (OS6) to test the null hypothesis that 25% or less patients were alive six months after the first infusion
    End point values
    PM01183
    Number of subjects analysed
    43 [2]
    Units: Subjects
        Yes
    14
        No
    29
    Notes
    [2] - OS6 was thus 32.6% (95% CI: 19.1-48.5%)
    No statistical analyses for this end point

    Secondary: Overall Response Rate

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    End point title
    Overall Response Rate
    End point description
    NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease Response rate (95% CI) (patients evaluable for efficacy, n=43) 2.3% (0.1-12.3%) Response rate (95% CI) (patients evaluable for response, n=42) 2.4% (0.1-12.6%) (One patient died due to toxicity before the first tumor evaluation and was excluded from the population of patients evaluable for response)
    End point type
    Secondary
    End point timeframe
    Overall period
    End point values
    PM01183
    Number of subjects analysed
    43
    Units: Subjects
        PR
    1
        SD
    15
        PD
    26
        NE
    1
    No statistical analyses for this end point

    Secondary: Progression-free Survival

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    End point title
    Progression-free Survival
    End point description
    End point type
    Secondary
    End point timeframe
    Overall period
    End point values
    PM01183
    Number of subjects analysed
    43 [3]
    Units: months
        median (confidence interval 95%)
    1.4 (1.2 to 2.3)
    Attachments
    Untitled (Filename: Kaplan-Meier plot of progression-free survival.bmp)
    Notes
    [3] - Events (%) 40 (93.0%)
    No statistical analyses for this end point

    Secondary: Progression-free survival Rates

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    End point title
    Progression-free survival Rates
    End point description
    End point type
    Secondary
    End point timeframe
    at Three and Six Months after the first PM01183 dose
    End point values
    PM01183
    Number of subjects analysed
    43
    Units: percentage
    arithmetic mean (confidence interval 95%)
        PFS3
    27.5 (14.1 to 41)
        PFS6
    14.6 (3.6 to 25.6)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    Overall Survival
    End point description
    End point type
    Secondary
    End point timeframe
    Overall period
    End point values
    PM01183
    Number of subjects analysed
    43 [4]
    Units: months
        arithmetic mean (confidence interval 95%)
    4 (3.1 to 5.4)
    Attachments
    Untitled (Filename: Kaplan-Meier plot of overall survival.bmp)
    Notes
    [4] - Events (%): 41 (95.3%)
    No statistical analyses for this end point

    Secondary: Overall Survival Rate

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    End point title
    Overall Survival Rate
    End point description
    End point type
    Secondary
    End point timeframe
    at 12 Months after the first PM01183 dose
    End point values
    PM01183
    Number of subjects analysed
    43
    Units: percentage
        arithmetic mean (confidence interval 95%)
    9.3 (0.6 to 18)
    No statistical analyses for this end point

    Secondary: Evolution of Tumor Marker CA19-9

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    End point title
    Evolution of Tumor Marker CA19-9
    End point description
    End point type
    Secondary
    End point timeframe
    During Treatment
    End point values
    PM01183
    Number of subjects analysed
    35 [5]
    Units: Subjects
        Decrease
    14
        No decrease
    21
    Attachments
    Untitled (Filename: CA19-9 variation.bmp)
    Notes
    [5] - High CA19-9 levels at baseline
    No statistical analyses for this end point

    Secondary: Pharmacokinetic parameters (CL)

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    End point title
    Pharmacokinetic parameters (CL)
    End point description
    End point type
    Secondary
    End point timeframe
    Treatment
    End point values
    PM01183
    Number of subjects analysed
    44 [6]
    Units: l/h
    median (standard deviation)
        Cycle 1
    12.5 ± 7
        Cycle 2
    13.4 ± 8.2
    Attachments
    Untitled (Filename: Total body clearance per cycle.bmp)
    Notes
    [6] - Cycle 1: N=44 Cycle 2: N=33
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall period
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    PM01183
    Reporting group description
    PM01183 was given at a dose of 7.0 mg FD as a 1-hour q3wk i.v. infusion. Each cycle lasted three weeks.

    Serious adverse events
    PM01183
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 44 (72.73%)
         number of deaths (all causes)
    42
         number of deaths resulting from adverse events
    3
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Blood creatine increased
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    tumour associated fever
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    tumour pain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    haemoptysis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Pneumonitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences causally related to treatment / all
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    9 / 44 (20.45%)
         occurrences causally related to treatment / all
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    1 / 1
    Thrombocytopenia
         subjects affected / exposed
    11 / 44 (25.00%)
         occurrences causally related to treatment / all
    16 / 16
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute prerenal failure
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Renal failure acute
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchopneumopathy
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Pneumonia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    PM01183
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 44 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Phlebitis
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    6
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Weight decreased
         subjects affected / exposed
    8 / 44 (18.18%)
         occurrences all number
    12
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    23 / 44 (52.27%)
         occurrences all number
    73
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    17
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    4
    Dyspnoea
         subjects affected / exposed
    7 / 44 (15.91%)
         occurrences all number
    8
    Hiccups
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    6
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 44 (18.18%)
         occurrences all number
    14
    Neutropenia
         subjects affected / exposed
    12 / 44 (27.27%)
         occurrences all number
    16
    Thrombocytopenia
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences all number
    5
    Nervous system disorders
    Lethargy
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    28 / 44 (63.64%)
         occurrences all number
    118
    Oedema peripheral
         subjects affected / exposed
    7 / 44 (15.91%)
         occurrences all number
    13
    Pyrexia
         subjects affected / exposed
    12 / 44 (27.27%)
         occurrences all number
    14
    Psychiatric disorders
    Depression
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    10
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    9 / 44 (20.45%)
         occurrences all number
    19
    Ascites
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    13 / 44 (29.55%)
         occurrences all number
    20
    Diarrhoea
         subjects affected / exposed
    14 / 44 (31.82%)
         occurrences all number
    40
    Nausea
         subjects affected / exposed
    28 / 44 (63.64%)
         occurrences all number
    58
    Vomiting
         subjects affected / exposed
    20 / 44 (45.45%)
         occurrences all number
    42
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    16 / 44 (36.36%)
         occurrences all number
    29

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jan 2011
    This protocol amendment included the following changes: 1. Included the collection of an additional blood sample from patients who consented to the PGx substudy, immediately before treatment with PM01183, to perform a gene expression profile (GEP) on purified circulating tumor cell (CTC)-enriched fractions. 2. Added contact information for the Central Laboratory for PGx Analyses.
    21 Nov 2011
    Included the following changes 1.Updated contact information for the Sponsor 2.Clarified: the protocol sections describing the laboratories for PGx tissue and blood sample processing and analysis and the inclusion criteria to allow the recruitment of patients who failed gemcitabine-containing adjuvant therapy within six months and with metastatic disease at study entry 3.Changed the inclusion criteria to set a maximum accepted age of 75 years-old, the inclusion criterion regarding bilirubin levels to require patients to have both total bilirubin≤ 1.5xULN and direct bilirubin≤ULN and the inclusion criterion regarding albumin levels 4.Clarified the eligibility criteria to exclude patients with rapidly deteriorating pancreatic cancer and/or uncontrolled symptoms, and patients who require or carry external drainage catheters (which are associated with an increased risk of infection) 5.Updated the inclusion criteria to reflect that the period of time that female patients must avoid becoming pregnant after treatment discontinuation had decreased from six months to six weeks, following the finding that only untraceable levels of PM01183 remain after six weeks 6.Updated information on the authorized formulations of PM01183 7.Updated the hemoglobin value allowed for treatment continuation to make it consistent with the inclusion criteria 8.Increased the albumin value allowed for treatment continuation, due to the relevance of albumin levels as an independent prognostic factor in pancreatic cancer 9.Clarified the rules for replacing patients and for considering patients evaluable for efficacy 10.Changed the collection time of a blood sample for PGx analysis to “any time before the start of the second PM01183 infusion”, as extending the collection period would help study logistics and treatment planning 11.Removed the description of the handling of PK samples in the protocol

    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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