Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35918   clinical trials with a EudraCT protocol, of which   5893   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A multicentre, phase II randomised controlled trial evaluating cabazitaxel versus docetaxel re-challenge for the treatment of metastatic Castrate Refractory Prostate Cancer, previously treated with docetaxel at inception of primary hormone therapy

    Summary
    EudraCT number
    2012-003835-40
    Trial protocol
    GB  
    Global end of trial date
    29 Apr 2016

    Results information
    Results version number
    v2(current)
    This version publication date
    13 May 2018
    First version publication date
    14 May 2017
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    No changes have been made to the EudraCT report. However, the MHRA rejected it because the End of Trial Declaration had not been submitted. This has now been submitted and so we need to resubmit the EudraCT report.

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    RG12-024
    Additional study identifiers
    ISRCTN number
    ISRCTN16465571
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    CRCTU reference number: PR2103, Sanofi study number: Cabaz_L_05879, Cancer Research UK number: A15721
    Sponsors
    Sponsor organisation name
    University of Birmingham
    Sponsor organisation address
    Room 119, Aston Webb Building, Birmingham, United Kingdom, B15 2TT
    Public contact
    Mr Nick Martin, Cancer Research UK Clinical Trials Unit, University of Birmingham, +44 01214145102, cantata@trials.bham.ac.uk
    Scientific contact
    Mr Nick Martin, Cancer Research UK Clinical Trials Unit, University of Birmingham, +44 01214145102, cantata@trials.bham.ac.uk
    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
    12 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of this phase II study are to determine the tolerability and activity of cabazitaxel compared with docetaxel re-challenge as second-line chemotherapy treatment in metastatic patients who received primary therapy with docetaxel.
    Protection of trial subjects
    What are the key risks related to therapeutic interventions you plan to monitor in this trial? How will these risks be minimised? For the following, clinical assessment 3 weekly will be carried out during treatment. *CARDIAC DISORDERS. *EAR & LABYRINTH DISORDER *EYE DISORDERS *GASTROINTESTINAL DISORDERS*GENERAL DISORDERS & ADMINISTRATION SITE CONDITIONS *IMMUNE SYSTEM DISORDERS *BLOOD & LYMPHATIC SYSTEM DISORDERS *INFECTIONS & INFESTATIONS *METABOLISM & NUTRITION DISORDERS *RENAL & URINARY DISORDERS *MUSCULOSKELETAL & CONNECTIVE TISSUE DISORDERS *SKIN & SUBCUTANEOUS TISSUE DISORDERS *VASCULAR DISORDERS *RESPIRATORY, THORACIC & MEDIASTINAL DISORDERS *NERVOUS SYSTEM DISORDERS *PSYCHIATRIC DISORDERS *REPRODUCTIVE SYSTEM & BREAST DISORDERS *INVESTIGATIONS (WEIGHT LOSS & RAISED LFTs) Patients may be required to undergo 1 additional CT or MRI scan in order to verify progression at trial entry. Data Protection: In routine correspondence between the CRCTU and the site patients will be referred to by their unique Trial Number, initials and date of birth. The patient’s consent will be obtained for this. All patient data (both paper and electronic) is securely stored and will only be accessible by authorised personnel in accordance with the CRCTU Quality Management System (QMS). In addition, patients who are participating in the STAMPEDE trial will be asked to consent to the sharing of some data between the CRCTU and the MRC CTU. This is to minimise the duplication of data taken from the same patient.
    Background therapy
    Premedication Regimen: Administer intravenously 30 minutes before each dose of cabazitaxel: * Antihistamine (chlorpheniramine 5 mg or equivalent antihistamine) *Dexamethasone 8 mg or equivalent steroid *H2 antagonist (ranitidine 50 mg or equivalent H2 antagonist) *Antiemetic prophylaxis (oral or intravenous) is recommended as needed, and should follow local policy. *Variations based on local practice can be considered after discussion with the Trial Office G-CSF: Patients experiencing severe neutropenia or neutropenic sepsis should be considered for G-CSF prophylaxis with subsequent cycles. The recommended anti-emetic regimen is: 30 minutes prior to docetaxel administration: * Ondansetron 8mg IV stat or equivalent * Dexamethasone 8mg IV stat or equivalent steroid Followed by: * Ondansetron 8mg BD/PRN for 3 days * Domperidone 20mg PO QDS/PRN
    Evidence for comparator
    Until recently there was a need for new treatments in advanced prostate cancer, but in 2010 de Bono and colleagues published the results of the TROPIC trial(10). TROPIC was a randomised phase III trial in men with mCRPC who had previously been treated with hormone therapy, but whose disease had progressed during or after treatment with docetaxel. Based on the results of the TROPIC trial, cabazitaxel, in combination with prednisone or prednisolone, was approved by the US Food and Drug Administration (June 2010) and the European Medicines Agency (March 2011), for the treatment of patients with mCRPC who have previously been treated with docetaxel. There are also four clinical trials currently recruiting which are assessing cabazitaxel safety and efficacy in this group of patients (NCT00417079, NCT01308580, NCT01308567, NCT01324583). In conclusion, treatment with cabazitaxel is a potential therapeutic option for patients with mCRPC whose disease has progressed during or after docetaxel-based therapy. Caution, however, must be employed due to its significant haematological toxicities.
    Actual start date of recruitment
    10 Dec 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
    United Kingdom: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    3
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    15 patients randomised in total; 7 to Cabazitaxel and 8 to Docetaxel. 1 patient in the Docetaxel group was found to be ineligible post-randomisation but remain in analysis since protocol states that on an intention to treat basis, all ineligible patients will be included. First patient randomised= 09-May-2013 Last patient randomised= 04-Jan-2016

    Pre-assignment
    Screening details
    Eligible: prostate CA, previously treated with 6 cycles of Docetaxel, confirmed progression, metastatic disease, ≥18, performance status 0-2, adequate blood results Exclusion criteria: prior chemotherapy other than docetaxel, progessive disease on docetaxel, active infection, malignant disease in last 5 years, active peripheral neuropathy

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    na

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cabazitaxel
    Arm description
    Cabazitaxel 25mg/m2 3 weekly plus prednisolone for up to 10 cycles
    Arm type
    Experimental

    Investigational medicinal product name
    Cabazitaxel
    Investigational medicinal product code
    XRP6258/RPR116258
    Other name
    Jevtana
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Cabazitaxel will be administered at a dose of 25 mg/m2 (in either 0.9% sodium chloride solution or 5% dextrose solution) as 1 hour intravenous infusion every three weeks, in combination with oral prednisolone 10 mg administered daily, throughout treatment.

    Arm title
    Docetaxel
    Arm description
    Docetaxel 75mg/m2 3 weekly plus prednisolone for up to 10 cycles
    Arm type
    Active comparator

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Docetaxel will be administered at a dose of 75 mg/m2 (in either 0.9% sodium chloride solution or 5% dextrose solution) as 1 hour intravenous infusion every three weeks, in combination with oral prednisolone 10 mg administered daily, throughout treatment.

    Number of subjects in period 1
    Cabazitaxel Docetaxel
    Started
    7
    8
    Completed
    7
    8
    Period 2
    Period 2 title
    End of trial
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    na

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cabazitaxel
    Arm description
    Cabazitaxel 25mg/m2 3 weekly plus prednisolone for up to 10 cycles
    Arm type
    Experimental

    Investigational medicinal product name
    Cabazitaxel
    Investigational medicinal product code
    XRP6258/RPR116258
    Other name
    Jevtana
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Cabazitaxel will be administered at a dose of 25 mg/m2 (in either 0.9% sodium chloride solution or 5% dextrose solution) as 1 hour intravenous infusion every three weeks, in combination with oral prednisolone 10 mg administered daily, throughout treatment.

    Arm title
    Docetaxel
    Arm description
    Docetaxel 75mg/m2 3 weekly plus prednisolone for up to 10 cycles
    Arm type
    Active comparator

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Docetaxel will be administered at a dose of 75 mg/m2 (in either 0.9% sodium chloride solution or 5% dextrose solution) as 1 hour intravenous infusion every three weeks, in combination with oral prednisolone 10 mg administered daily, throughout treatment.

    Number of subjects in period 2
    Cabazitaxel Docetaxel
    Started
    7
    8
    Completed
    7
    8

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Cabazitaxel
    Reporting group description
    Cabazitaxel 25mg/m2 3 weekly plus prednisolone for up to 10 cycles

    Reporting group title
    Docetaxel
    Reporting group description
    Docetaxel 75mg/m2 3 weekly plus prednisolone for up to 10 cycles

    Reporting group values
    Cabazitaxel Docetaxel Total
    Number of subjects
    7 8 15
    Age categorical
    Date of birth is collected at randomisation. All subjects are required to be over 18.
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    4 1 5
        From 65-84 years
    3 7 10
        85 years and over
    0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    62.7 (57.5 to 75.2) 69.9 (66.1 to 72.5) -
    Gender categorical
    Units: Subjects
        Female
    0 0 0
        Male
    7 8 15
    Experiencing disease related pain
    Stratification variable of whether a patient has disease related pain at randomisation
    Units: Subjects
        Disease related pain
    4 5 9
        No disease related pain
    3 3 6
    Prior exposure to a new generation hormone therapy
    Stratification variable of prior exposure to a new generation hormone therapy
    Units: Subjects
        Prior exposure to a new gen hormone therapy
    1 2 3
        No prior exposure to a new gen hormone therapy
    6 6 12
    Prior hormone used
    For those who used a prior new generation hormone
    Units: Subjects
        No prior hormone
    6 6 12
        Abiraterone
    1 0 1
        Enzalutamide
    0 2 2
        Other hormone
    0 0 0

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Cabazitaxel
    Reporting group description
    Cabazitaxel 25mg/m2 3 weekly plus prednisolone for up to 10 cycles

    Reporting group title
    Docetaxel
    Reporting group description
    Docetaxel 75mg/m2 3 weekly plus prednisolone for up to 10 cycles
    Reporting group title
    Cabazitaxel
    Reporting group description
    Cabazitaxel 25mg/m2 3 weekly plus prednisolone for up to 10 cycles

    Reporting group title
    Docetaxel
    Reporting group description
    Docetaxel 75mg/m2 3 weekly plus prednisolone for up to 10 cycles

    Primary: Clinical Progression Free Survival (CPFS)

    Close Top of page
    End point title
    Clinical Progression Free Survival (CPFS)
    End point description
    Clinical progression is defined as the earliest time between date of randomisation and either date of occurrence of pain progression (date patient is seen in clinic and pain progression identified), date of occurrence of a cancer-related skeletal-related event or date of death from any cause. Patients who do not suffer one of the specified events are censored at the date they were last known to be event free.
    End point type
    Primary
    End point timeframe
    The time between the date of randomisation and the date of clinical progression. 'Clinical progression' is an event defined as the clinician being of the opinion that disease has progressed.
    End point values
    Cabazitaxel Docetaxel
    Number of subjects analysed
    7
    8
    Units: Number of events (as defined below)
        Clinically Progressed
    2
    4
        Hasn't clinically progressed
    5
    4
    Statistical analysis title
    Not enough patients for analysis
    Statistical analysis description
    There are not enough patients to justify any form of formal statistical analysis since the trial stopped very short of numbers intended. One patient on the Docetaxel arm was ineligible but has been included due the protocol stating 'Intention to treat'. 2 out of 7 Cabazitaxel patients progressed (either had pain progression or died) and 4 out of 8 Docetaxel patients (either had pain progression or died) Therefore, it can only be a very descriptive statement
    Comparison groups
    Cabazitaxel v Docetaxel
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 1 [2]
    Method
    Not done
    Parameter type
    40
    Confidence interval
    Notes
    [1] - Not enough patients to justify any form of formal statistical analysis since trial stopped very short of numbers intended.1 patient on the Docetaxel arm was ineligible but has been included due to the protocol stating 'Intention to treat'. For patients who received trial treatment (including ineligible patient ) 2 out of 7 Cabazitaxel patients progressed and 4 out of 8 Docetaxel patients progressed. Therefore, it can only be descriptive.
    [2] - There are not enough patients to justify any form of formal statistical analysis since the trial stopped very short of numbers intended. The p-value of 1 has been input by default to fill in the box. Also for parameter value.

    Secondary: Skeletal-related-event-free-survival

    Close Top of page
    End point title
    Skeletal-related-event-free-survival
    End point description
    No skeletal-related events have occured
    End point type
    Secondary
    End point timeframe
    The time between the date of randomisation and the date of a skeletal-related event. Those who have no skeletal-related event are censored at last date of follow-up.
    End point values
    Cabazitaxel Docetaxel
    Number of subjects analysed
    7
    8
    Units: Number of events (as defined below)
        Skeletal-related event
    0
    0
        No skeletal-related event
    7
    8
    No statistical analyses for this end point

    Secondary: Pain progression-free survival

    Close Top of page
    End point title
    Pain progression-free survival
    End point description
    The number of patients who had pain progression following randomisation was extremely small (two on the Docetaxel arm and one on the Cabazitaxel arm). This is not enough patients to carry out any formal statistical testing.
    End point type
    Secondary
    End point timeframe
    Time from date of randomisation to date of pain progression. Patients who are pain free are censored at the date of last follow-up visit.
    End point values
    Cabazitaxel Docetaxel
    Number of subjects analysed
    7
    8
    Units: Number of events (as defined below)
        Pain progression
    1
    2
        No pain progression
    6
    6
    No statistical analyses for this end point

    Secondary: Toxicity (National Cancer Institute CTC V4)

    Close Top of page
    End point title
    Toxicity (National Cancer Institute CTC V4)
    End point description
    Treatment safety is assessed by the number of patients developing adverse events (AE's) during treatment (acute toxicities) and after trial therapy has been completed (late toxicities). Late toxicity is defined as 30 days after the last injection of cabazitaxel or docetaxel. AE's will be classified by causality, grade, type, duration and system involved. This information will be recorded in the Adverse events section.
    End point type
    Secondary
    End point timeframe
    Adverse events are recorded both during treatment and after trial therapy has been completed
    End point values
    Cabazitaxel Docetaxel
    Number of subjects analysed
    7
    7
    Units: Number of patients developing AE's
    7
    8
    No statistical analyses for this end point

    Secondary: Overall Survival

    Close Top of page
    End point title
    Overall Survival
    End point description
    There have been only 4 deaths in total; 1 on the Cabazitaxel arm and 3 on the Docetaxel arm. All 4 deaths were disease related. There are not enough events to carry out any formal statistical testing.
    End point type
    Secondary
    End point timeframe
    Time between date of randomisation and the date of death from any cause. Patients who do not die will be censored at the date of last follow-up or date last known to be alive.
    End point values
    Cabazitaxel Docetaxel
    Number of subjects analysed
    7
    8
    Units: Number of events (as defined below)
        Alive
    6
    6
        Died
    1
    2
    No statistical analyses for this end point

    Secondary: PSA-progression free survival

    Close Top of page
    End point title
    PSA-progression free survival
    End point description
    Nine patients had a least one raised PSA at a follow-up visit (5 Cabazitaxel and 4 Docetaxel). There are therefore not enough events to carry out any formal statistical testing.
    End point type
    Secondary
    End point timeframe
    Time between date of randomisation and the date a biochemical failure (PSA progression). Patients who do not progress are censored at time of last follow up visit.
    End point values
    Cabazitaxel Docetaxel
    Number of subjects analysed
    7
    8
    Units: Number of events (as defined below)
        PSA progression
    5
    4
        No PSA progression
    2
    4
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events will be documented and reported from date of commemncement of treatment until 30 days after treatment finishes.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Cabazitaxel
    Reporting group description
    -

    Reporting group title
    Docetaxel
    Reporting group description
    One patient did not receive any treatment at all so will not be counted as being exposed.

    Serious adverse events
    Cabazitaxel Docetaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 7 (71.43%)
    2 / 7 (28.57%)
         number of deaths (all causes)
    1
    3
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lung infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Cabazitaxel Docetaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    7 / 7 (100.00%)
    Vascular disorders
    Hot flashes
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Phlebitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
    Additional description: Cyst on groin
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 7 (57.14%)
    4 / 7 (57.14%)
         occurrences all number
    25
    21
    Fever
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Malaise
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    General disorders and administration site conditions- Other, specify
    Additional description: Common cold
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Psychiatric disorders
    depression
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Bruising
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    6
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    Alkaline phosphatase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    Creatinine increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Weight loss
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Investigations - Other, specify
    Additional description: White blood cell count increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 7 (71.43%)
    2 / 7 (28.57%)
         occurrences all number
    21
    6
    Febrile Neutropenia
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Dyspnea
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 7 (14.29%)
         occurrences all number
    8
    2
    Epistaxis
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 7 (0.00%)
         occurrences all number
    5
    0
    Sore throat
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders - Other, specify
    Additional description: Watery nose
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    dysgeusia
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 7 (14.29%)
         occurrences all number
    9
    2
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Lethargy
         subjects affected / exposed
    3 / 7 (42.86%)
    2 / 7 (28.57%)
         occurrences all number
    5
    5
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 7 (28.57%)
         occurrences all number
    4
    3
    Nervous system disorders - Other, specify
    Additional description: Neurotoxicity fingers
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    2
    Eye disorders
    Blurred Vision
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Watering eyes
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 7 (28.57%)
         occurrences all number
    1
    5
    Diarrhoea
         subjects affected / exposed
    6 / 7 (85.71%)
    3 / 7 (42.86%)
         occurrences all number
    8
    16
    Dry mouth
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Mucositis oral
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    3 / 7 (42.86%)
    2 / 7 (28.57%)
         occurrences all number
    3
    5
    Vomiting
         subjects affected / exposed
    3 / 7 (42.86%)
    2 / 7 (28.57%)
         occurrences all number
    3
    2
    Gastrointestinal disorders- Other, specify
         subjects affected / exposed
    3 / 7 (42.86%)
    2 / 7 (28.57%)
         occurrences all number
    3
    3
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Urinary frequency
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 7 (42.86%)
         occurrences all number
    0
    13
    Dry Skin
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Nail ridging
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    4
    Skin and subcutaneous tissue disorders - Other, specify
    Additional description: Rash on Hand
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 7 (28.57%)
         occurrences all number
    2
    7
    Bone pain
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Arthralgia
         subjects affected / exposed
    0 / 7 (0.00%)
    4 / 7 (57.14%)
         occurrences all number
    0
    7
    Muscle weakness lower limb
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Muscle weakness upper limb
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    3
    3
    Hyperkalaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Hypoalbuminemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    10
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Gum Infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Lung infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Nov 2012
    Amendment number 1 Protocol v 2.0. Update to comply with MHRA request re original submission on 26-Oct-2012. Update inclusion/exclusion criteria: patients with bilirubin equal or larger than ULN must be excluded; ANC notation made consistent throughout protocol. New wording: The radiation dose received from an additional set of scans is equivalent to less than 10 years of background radiation. The risk to you from this extra radiation will be negligible. Comments/ explanation/ reasons for substantial amendment: Two sentences have been added to the original paragraph (PIS, page 7) in order to explain the risk of an additional set of scans to the patient. The addition of these sentences to the Patient Information Sheet was requested during the NHS R&D approval process so that the Patient Information Sheet would match the wording supplied by the Medical Physics Expert in the original ethics application (submitted 24 October 2012). (
    27 Jun 2014
    Amendment number 4 Substantial Amendment Inclusion of text regarding optional tissue collection sub-study; change to haemoglobin notation. Changes to protocol text include: 1. Change to version no and date on page 1 and page 2, and in header/footer 2. Addition of the ISRCTN on the cover pagethis had not been received when the protocol was first submitted. 3. Clarification of wording in screening section(Schedule of Assessments, page 10) patients should receive "up to" not "at least" 6 cycles of docetaxel in their prior treatment. 4. Addition of section 3.3 on page 21 regarding the optional future Tissue Collection Substudy. This substudy is mentioned in the Patient Information Sheet and included on the Informed Consent Form, but had been removed from the protocol at a draft stage and not reinstated. 5. Change to notation for haemoglobin: from 10g/dL to 100g/L. Most laboratories use the 100g/L notation now. 6. Before a new treatment cycle begins, the patient's platelet count must be greater than or equal to 100 x10^9 L. This has been corrected on pages 25 and 27. 7. On page 24, addition of information regarding the use of prednisolone as a NIMP. 8. On page 25, clarification that sites may be able to adhere to local practice if the site's premedication regimen is different to that currently listed in the protocol, but only after agreeing this regimen with the Trial Office. 9. Change to definition of end date for the purposes of the main REC approval on in section 11, page 39 (removing the reference to "latest data capture" as this phrase is unclear). 10. Change to section 12.4 to update the statistical information. The incorrect numbers were retained from an earlier draft of the protocol. 11. Corrections of several minor misspellings (on page 25).

    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.
    Early termination of trial occurred leadind to a small number of subjects analysed. MHRA and ethics informed on 29-Apr-2016.
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA