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    Clinical Trial Results:
    A follow-up study exploring number of cycles for weekly treatment with Paclical® in patients with metastatic breast cancer, previously treated in study OAS-11PAC-W

    Summary
    EudraCT number
    		 2011-002456-14
    Trial protocol
    		 LV  
    Global end of trial date
    25 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2017
    First version publication date
    14 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OAS-11PAC-W-fu
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oasmia Pharmaceutical AB
    Sponsor organisation address
    Vallongatan 1, Uppsala, Sweden, SE-752 28
    Public contact
    Nina Heldring, Oasmia Pharmaceutical AB, +46 18 50 54 40, nina.heldring@oasmia.com
    Scientific contact
    Nina Heldring, Oasmia Pharmaceutical AB, +46 18 50 54 40, nina.heldring@oasmia.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
    20 Nov 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Apr 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To explore the number of cycles for weekly treatment with Paclical®
    Protection of trial subjects
    Laboratory measurements were assessed to monitor safety of patients (haematology and clinical chemistry). Blood pressure, pulse rate and body temperature were measured prior and during the infusion of IMP. Patients were withdrawn if medically necessary according to investigator.
    Background therapy
    		 -
    Evidence for comparator
    		 N.A.
    Actual start date of recruitment
    28 Jan 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 22
    Country: Number of subjects enrolled
    Latvia: 7
    Worldwide total number of subjects
    29
    EEA total number of subjects
    7
    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)
    22
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Female patients with histologically confirmed metastatic breast cancer completing the study OAS-11PAC-W were eligible. Patients with progressive disease or unacceptable toxicity at last visit of OAS-11PAC-W or with dose-reduction during OAS-11PAC-W were excluded. Out of 31 screened patients, 22 were included and 2 were screening failures.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Paclical 100 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 110 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 120 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 130 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 140 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 150 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 160 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 170 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 180 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 190 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 210 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 230 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Arm title
    		 Paclical 240 mg/m2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclical
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclical consists of paclitaxel and XR-17. The powder was reconstituted using Lactated or Acetated Ringer´s solution. The dose was calculated based on body surface area (mg paclitaxel/m2). The treatment was administered over approximately 30 minutes once weekly.

    Number of subjects in period 1
    		Paclical 100 mg/m2 Paclical 110 mg/m2 Paclical 120 mg/m2 Paclical 130 mg/m2 Paclical 140 mg/m2 Paclical 150 mg/m2 Paclical 160 mg/m2 Paclical 170 mg/m2 Paclical 180 mg/m2 Paclical 190 mg/m2 Paclical 210 mg/m2 Paclical 230 mg/m2 Paclical 240 mg/m2
    Started
    3
    3
    2
    3
    2
    2
    3
    3
    2
    1
    1
    2
    2
    Completed
    2
    1
    1
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Not completed
    1
    2
    1
    1
    2
    2
    2
    3
    2
    1
    1
    2
    2
         Adverse event, serious fatal
    -
    1
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
         Physician decision
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    1
         Consent withdrawn by subject
    -
    -
    -
    1
    -
    1
    1
    3
    1
    -
    1
    1
    1
         Protocol violation, fulfilling exclusion criteria
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    1
    -
    1
    -
    1
    1
    -
    -
    1
    1
    -
    -
    -

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 29 29
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 22 22
        From 65-84 years
    		 7 7
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.1 ( 10.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 29 29
        Male
    		 0 0
    Child bearing potential
    Units: Subjects
        Yes
    		 9 9
        No
    		 20 20
    HER2 assessment
    Units: Subjects
        HER2 positive
    		 8 8
        HER2 negative
    		 21 21
    ECOG status
    ECOG = Eastern Cooperative Oncology Group performance status
    Units: Subjects
        Status 0
    		 26 26
        Status 1
    		 3 3
        Status 2
    		 0 0
        Status 3
    		 0 0
        Status 4
    		 0 0
        Status 5
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Paclical 100 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 110 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 120 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 130 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 140 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 150 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 160 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 170 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 180 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 190 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 210 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 230 mg/m2
    Reporting group description
    		 -

    Reporting group title
    Paclical 240 mg/m2
    Reporting group description
    		 -

    Subject analysis set title
    Entire study population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All included patients, irrespective of treatment dose

    Subject analysis set title
    Completers
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    This data set includes the patients reaching an endpoint (i.e. complete response, disease progression, unacceptable toxicity). The 22 withdrawn patients are not included in this data set.

    Primary: Number of cycles for weekly treatment of Paclical

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    End point title
    		 Number of cycles for weekly treatment of Paclical [1] [2]
    End point description
    The number of treatment cycles for Paclical weekly treatment could not be obtained.
    End point type
    Primary
    End point timeframe
    Assessment was made until a reason for completion (complete response, unacceptable toxicity or progressive disease).
    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: Given the exploratory nature (i.e. to determine the number of cycles for weekly administration), no statistical hypothesis testing was performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Due to withdrawal primary endpoint data were not available for all treatment arms.
    End point values
    		 Paclical 100 mg/m2 Paclical 110 mg/m2 Paclical 120 mg/m2 Paclical 130 mg/m2 Paclical 160 mg/m2
    Number of subjects analysed
    2
    1
    1
    2
    1
    Units: Treatment cycles
        median (full range (min-max))
    8 (8 to 8)
    10 (10 to 10)
    13 (13 to 13)
    14 (8 to 20)
    15 (15 to 15)
    No statistical analyses for this end point

    Secondary: Reason for completion due to endpoint

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    End point title
    		 Reason for completion due to endpoint
    End point description
    End point type
    Secondary
    End point timeframe
    From start of study (5th treatment cycle) until the patient discontinued the study due to any of the three pre-defined endpoints.
    End point values
    		 Completers
    Number of subjects analysed
    7
    Units: Patients
        Complete response
    1
        Disease progression
    2
        Unacceptable toxicity
    4
    No statistical analyses for this end point

    Secondary: Tumour response

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    End point title
    		 Tumour response
    End point description
    Tumour response was assessed by CT evaluated according to RECIST 1.1 at the radiology department of the sites. The patient´s last assessment is presented. The reason is that a limited number of patients were treated more than 8 cycles and that not all patients had an end of treatment assessment due to short interval between last scheduled CT and study withdrawal.
    End point type
    Secondary
    End point timeframe
    Tumour response was assessed at entry into the present follow-up study (treatment cycle 5) and every 8th week and at end of study.
    End point values
    		 Entire study population
    Number of subjects analysed
    29
    Units: Patients
        Complete response
    1
        Partial response
    9
        Stable disease
    16
        Progressive disease
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first treatment administration in the follow-up study (cycle 5) until one week (7-9 days) after the last treatment or withdrawal.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Entire study population
    Reporting group description
    		 All patients included in the study (one patient never received any treatment in this follow-up study but is still included in this safety data set).

    Serious adverse events
    		 Entire study population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 28 (10.71%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm progression
    Additional description: Relation to treatment assessed by investigator
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Cardiopulmonary failure
    Additional description: Relation to treatment assessed by investigator
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    Administration site abscess
    Additional description: Relation to treatment assessed by investigator
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Entire study population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 28 (67.86%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    4 / 28 (14.29%)
         occurrences all number
    4
    Neuropathy peripheral
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Paraesthesia
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Leukocytosis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Leukopenia
         subjects affected / exposed
    4 / 28 (14.29%)
         occurrences all number
    4
    Neutropenia
         subjects affected / exposed
    5 / 28 (17.86%)
         occurrences all number
    6
    Neutrophilia
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    7 / 28 (25.00%)
         occurrences all number
    8
    Infusion site phlebitis
         subjects affected / exposed
    5 / 28 (17.86%)
         occurrences all number
    6
    Injection site extravasation
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Spinal pain
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Visual acuity reduced
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Pneumothorax
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Nail discolouration
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Nail disorder
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Onychoclasis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Skin erosion
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Skin ulcer
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Onychomadesis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Renal and urinary disorders
    Enuresis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Aug 2012
    This is a follow-up of a study intended to be a phase I/II (OAS-11PAC-W). When the phase II part of the main study was removed this also warranted changes in the present follow-up study.

    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.
    Since no MTD was established in OAS-11PAC-W, patients in the present follow-up were treated with different doses. A high withdrawal rate resulting in a small sample size limits the possibility to draw conclusions regarding number of treatment cycles.
    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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