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    Clinical Trial Results:
    Phase II, Open-Label, Randomized, Controlled Study of PM060184 in Advanced, Hormone Receptor Positive, HER2 negative Breast Cancer Patients in Third or Fourth Line Setting.

    Summary
    EudraCT number
    		 2015-002395-24
    Trial protocol
    		 ES   BE  
    Global end of trial date
    30 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Nov 2018
    First version publication date
    16 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PM60184-B-001-15
    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",, Colmenar Viejo, Madrid, Spain, 28770
    Public contact
    Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.,, Pharma Mar, S.A., 34 91846 60 00, clinicaltrials@pharmamar.com
    Scientific contact
    Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.,, Pharma Mar, S.A., 34 91846 60 00, 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
    03 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To Evaluate the efficacy of PM060184 in terms of progression-free survival at 4 months (PFS4) in third or fourth line setting in the subset population of advanced, hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative, breast carcinoma
    Protection of trial subjects
    The study was in compliance with ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 Primary antiemetic prophylaxis was compulsory prior to all PM060184 administrations. Standard treatment, according to ASCO guidelines, was administered: - 5-HT3 antagonists (ondansetron 8 mg or equivalent). - Steroids (dexamethasone 8 mg or equivalent). - Both oral and i.v. formulations were allowed, following the local institutional standards. If necessary, additional and/or extended antiemetic treatment could be considered (according to the Investigators’ standard practice).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Feb 2016
    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: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    18
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 At cutoff date, 22 patients had been included in the 1st stage: 21 were treated and evaluable for safety, and 18 were evaluable for the primary efficacy endpoint (PFS4). Patients enrollment between 12Feb2016 and 30Oct2017 (date of last F-Up, clinical cutoff) and corresponds to the 1st stage. All the patients were enrolled at 5 sites in Spain.

    Pre-assignment
    Screening details
    		 Screening details: IC Signed,Age ≥18, Histologically diagnosis BC,Tumors HR+ & HER2-,2-3 chemotherapy lines,Previous treatment anthracyclines&taxanes,ECOG: PS 0 or 1,Adequate marrow,liver and kidney function, Normal LVEF by ECHO or MUGA,Life expectancy ≥ 3 mo.,Recovery grade≤1 from any toxicity,Peripheral neuropathy grade ≤ 1 for AE,negative pre

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 PM060184
    Arm description
    		 The only drug administered and evaluated was PM060184, which was administered i.v. via a central line or a peripheral venous catheter (in 5 or 1-min administrations) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    PM060184
    Investigational medicinal product code
    PM060184
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The only drug administered and evaluated was PM060184, which was administered i.v. via a central line or a peripheral venous catheter (in 5 or 1-min administrations) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle). The drug substance PM060184-CD is a mixture of PM060184 and 2-hydroxypropyl-β-cyclodextrin. PM060184 drug product (DP) is provided as a sterile lyophilized powder for concentrate for solution for infusion with a strength of 15 mg of the active moiety PM060184. Before use, the vials should be reconstituted with 6 mL of water for injection to give a solution containing 2.5 mg/mL of PM060184. PM060184 as 15-mg DP was developed for i.v. administration. Prior to administration, the reconstituted vials were further diluted with a dextrose 5% solution for infusion. Each 15-mg vial of PM060184 was a single-use vial. The diluted solution should be protected from light exposure.

    Number of subjects in period 1
    		PM060184
    Started
    22
    Completed
    0
    Not completed
    22
         Clinical deterioration
    1
         Never treated
    1
         Progressive disease
    12
         Treatment-related adverse event
    2
         Patient refusal to treatment
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PM060184
    Reporting group description
    		 The only drug administered and evaluated was PM060184, which was administered i.v. via a central line or a peripheral venous catheter (in 5 or 1-min administrations) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle).

    Reporting group values
    		 PM060184 Total
    Number of subjects
    		 22 22
    Age categorical
    Units: Subjects
        18-49
    		 11 11
        50-69
    		 8 8
        ≥70
    		 3 3
    Age continuous
    Units: years
        median (full range (min-max))
    		 51 (36 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 0 0
    Race
    Units: Subjects
        White
    		 21 21
        Other (Hispanic)
    		 1 1
    ECOG PS
    Units: Subjects
        PS 0
    		 11 11
        PS 1
    		 11 11
    Stage at diagnosis
    Units: Subjects
        Stage I
    		 1 1
        Stage IIA
    		 8 8
        Stage IIB
    		 2 2
        Stage IIIA
    		 3 3
        Stage IIIC
    		 2 2
        Stage IV
    		 5 5
        Stage UK
    		 1 1
    Primary tumor site
    Units: Subjects
        Bilateral
    		 2 2
        Left
    		 11 11
        Right
    		 9 9
    Hystology type
    Units: Subjects
        Ductal
    		 22 22
    Histology grade
    G: Grade
    Units: Subjects
        G1: Well differentiated
    		 2 2
        G2: Moderately differentiated
    		 16 16
        G3: Poorly differentiated
    		 2 2
        G4: Undifferentiated
    		 1 1
        GX: Grade cannot be assessed
    		 1 1
    Second breast cancer
    Units: Subjects
        Yes
    		 1 1
        No
    		 21 21
    Hormone Receptor
    Units: Subjects
        Both hormone receptors positive
    		 17 17
        Estrogen positive
    		 5 5
    HER2 negative
    FISH: fluorescence in situ hybridization
    Units: Subjects
        HercepTest
    		 15 15
        HercepTest and FISH
    		 7 7
    Ki67/MIB-1
    Units: Subjects
        <5%
    		 2 2
        5-10%
    		 1 1
        >10
    		 13 13
        ND/UK
    		 6 6
    BRCA status
    Patient had BRCA2 mutation and no sites of measurable disease reported in the source documents, but she was never treated with PM060184 and was excluded from the analysis of efficacy and safety.
    Units: Subjects
        No
    		 3 3
        UK
    		 18 18
        Yes
    		 1 1
    Number of sites involved
    Units: Subjects
        0 site
    		 1 1
        1 site
    		 1 1
        2 sites
    		 8 8
        3 sites
    		 6 6
        4 sites
    		 3 3
        5 sites
    		 2 2
        6 sites
    		 1 1
    Peripheral neuropathy
    Units: Subjects
        No
    		 15 15
        Yes
    		 7 7
    Type of peripheral neuropathy
    Units: Subjects
        Both (motor and sensory)
    		 3 3
        Sensory
    		 4 4
        No peripheral neuropathy
    		 15 15
    NCI-CTCAE grade
    According to the NCI-CTCAE v.4.
    Units: Subjects
        Grade 1
    		 4 4
        Grade 2
    		 3 3
        No peripheral neuropathy
    		 15 15
    Prior radiotherapy
    Units: Subjects
        Yes
    		 16 16
        No
    		 6 6
    Prior surgery for primary treatment
    Units: Subjects
        Mastectomy
    		 11 11
        Breast-conserving surgery
    		 8 8
        No surgery
    		 3 3
    Number of prior lines
    Units: Subjects
        2 lines
    		 2 2
        3 lines
    		 3 3
        4 lines
    		 4 4
        ≥5 lines
    		 13 13
    Number of prior lines for advanced/metastatic disease
    Includes chemotherapy and hormonotherapy.
    Units: Subjects
        2 lines
    		 7 7
        3 lines
    		 5 5
        ≥5 lines
    		 10 10
    Number of prior chemotherapy lines
    Includes neoadjuvant, adjuvant and advanced chemotherapy
    Units: Subjects
        2 lines
    		 4 4
        3 lines
    		 13 13
        4 lines
    		 4 4
        5 lines
    		 1 1
    Number of prior advanced chemotherapy lines
    Units: Subjects
        2 lines
    		 14 14
        3 lines
    		 8 8
    Best response to last prior therapy
    NE, not evaluable; PD, disease progression; PR, partial response; SD, stable disease; UK, unknown
    Units: Subjects
        PR
    		 4 4
        SD
    		 11 11
        PD
    		 4 4
        UK/NE
    		 3 3
    Weight
    Units: Kg
        median (full range (min-max))
    		 63.7 (48 to 109.5) -
    Height
    Units: cm
        median (full range (min-max))
    		 160 (151 to 168) -
    BSA
    BSA: Body Surface Area
    Units: m2
        median (full range (min-max))
    		 1.6 (1.6 to 2.2) -
    Time from first diagnosis to first PM060184 infusion
    Data on 21 patients (one patient was never treated with PM060184)
    Units: months
        median (full range (min-max))
    		 108.7 (14.3 to 416.5) -
    Time from first diagnosis of advance disease to first PM060184 infusion
    Data on 21 patients (one patient was never treated with PM060184)
    Units: months
        median (full range (min-max))
    		 35.4 (11.8 to 132.8) -
    Time from prior last progression before study entry
    Patient signed informed consent on 20 September 2016. Although suspicion of disease progression was previous (20 August 2016), PD was confirmed through CT scan on 28 September 2016 and PM060184 treatment was started on 29 September 2016.
    Units: months
        median (full range (min-max))
    		 0.4 (-0.3 to 1.5) -
    Time from stop date of last prior therapy to study entry
    Units: months
        median (full range (min-max))
    		 0.7 (0.2 to 2.4) -
    Number of sites involved
    Units: Sites
        median (full range (min-max))
    		 3 (0 to 6) -
    Number of prior lines
    Units: Lines
        median (full range (min-max))
    		 5 (2 to 8) -
    Number of prior lines for advanced/metastatic disease
    Includes neoadjuvant, adjuvant and advanced chemotherapy
    Units: Lines
        median (full range (min-max))
    		 3 (2 to 7) -
    Number of prior chemotherapy lines
    Includes neoadjuvant, adjuvant and advanced chemotherapy
    Units: Lines
        median (full range (min-max))
    		 3 (2 to 5) -
    Number of prior advanced chemotherapy lines
    Units: lines
        median (full range (min-max))
    		 2 (2 to 3) -
    Progression-free interval
    Units: months
        median (full range (min-max))
    		 0.4 (-0.3 to 1.5) -

    End points

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    End points reporting groups
    Reporting group title
    PM060184
    Reporting group description
    		 The only drug administered and evaluated was PM060184, which was administered i.v. via a central line or a peripheral venous catheter (in 5 or 1-min administrations) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle).

    Primary: Progression-free survival rate at four months (PFS4)

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    End point title
    		 Progression-free survival rate at four months (PFS4) [1]
    End point description
    Progression-free survival rate at four months (PFS4), defined as the rate estimate of the percentage of patients who were alive and progression-free at 16 weeks (~4 months) after the first treatment administration.
    End point type
    Primary
    End point timeframe
    Overall period
    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: The threshold for proving antitumor activity (at least nine patients reaching PFS4) was not reached, the primary endpoint was unmet, and the study was closed without recruiting more patients in the first stage and without opening the second stage.
    End point values
    		 PM060184
    Number of subjects analysed
    18 [2]
    Units: percentage
    number (confidence interval 95%)
        Yes
    11.1 (1.4 to 34.7)
        No
    88.9 (65.3 to 98.6)
    Notes
    [2] - Four patients were not considered evaluable for efficacy
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    OS, defined as the time from the first day of treatment to the date of death or last contact.
    End point type
    Secondary
    End point timeframe
    Overall period
    End point values
    		 PM060184
    Number of subjects analysed
    18 [3]
    Units: months
        median (confidence interval 95%)
    6.6 (4.5 to 999)
    Notes
    [3] - Four patients were not considered evaluable for efficacy 999= not reached
    No statistical analyses for this end point

    Secondary: Progression-free Survival

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    End point title
    		 Progression-free Survival
    End point description
    PFS, defined as the time from the first day of study treatment to the day of negative efficacy assessment (progression or death) or last tumor evaluation PFS at 6 months (95% CI): 9.7% (0-27.4)
    End point type
    Secondary
    End point timeframe
    Overall period
    End point values
    		 PM060184
    Number of subjects analysed
    18 [4]
    Units: months
        median (confidence interval 95%)
    1.9 (1.2 to 3.8)
    Notes
    [4] - Four patients were not considered evaluable for efficacy
    No statistical analyses for this end point

    Secondary: Overall Response Rate

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    End point title
    		 Overall Response Rate
    End point description
    ORR, defined as the percentage of patients with objective response, either CR or PR according to the RECIST v.1.1 criteria CR, complete response; ORR, overall response rate; PD, disease progression; PR, partial response; SD, stable disease. ORR (95% CI) 5.6% (0.1-27.3%) Clinical benefit rate (CR+PR+SD ≥ 4 months) (95% CI) 16.7% (3.6-41.4%) Only one patient achieved a partial response, which lasted 1.9 months
    End point type
    Secondary
    End point timeframe
    Overall period
    End point values
    		 PM060184
    Number of subjects analysed
    18 [5]
    Units: subjects
        PR
    1
        SD
    8
        PD
    9
    Notes
    [5] - Four patients were not considered evaluable for efficacy'
    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
    18.0
    Reporting groups
    Reporting group title
    PM060184
    Reporting group description
    		 -

    Serious adverse events
    		 PM060184
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 21 (19.05%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Wrist surgery
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PM060184
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 21 (100.00%)
    Investigations
    Alt increased
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    3
    Ast increased
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    4
    Weight decreased
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    3
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    9 / 21 (42.86%)
         occurrences all number
    39
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    4
    Thrombocytopenia
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    18 / 21 (85.71%)
         occurrences all number
    59
    Pyrexia
         subjects affected / exposed
    5 / 21 (23.81%)
         occurrences all number
    5
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    11 / 21 (52.38%)
         occurrences all number
    24
    Constipation
         subjects affected / exposed
    5 / 21 (23.81%)
         occurrences all number
    9
    Diarrhoea
         subjects affected / exposed
    6 / 21 (28.57%)
         occurrences all number
    13
    Nausea
         subjects affected / exposed
    13 / 21 (61.90%)
         occurrences all number
    23
    Vomiting
         subjects affected / exposed
    6 / 21 (28.57%)
         occurrences all number
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    3
    Rhinorrhoea
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    14
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    5
    Back pain
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    6
    Bone pain
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    4
    Myalgia
         subjects affected / exposed
    5 / 21 (23.81%)
         occurrences all number
    11
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    8 / 21 (38.10%)
         occurrences all number
    20
    Hypophosphataemia
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    3

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The threshold for proving antitumor activity (at least nine patients reaching PFS4) was not reached, the primary endpoint was unmet, and the study was closed without recruiting more patients in the first stage and without opening the second stage
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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