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    Clinical Trial Results:
    Pancreatic Resectability in Cancers with Known Limited Extension (PRICKLE) - A single-centre phase 2a study of Gemcitabine plus Nab-paclitaxel for borderline unresectable locally advanced pancreatic cancer.

    Summary
    EudraCT number
    		 2013-004200-19
    Trial protocol
    		 GB  
    Global end of trial date
    26 Oct 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    PRICKLE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02124369
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cambridge University Hospitals NHS Foundation Trust
    Sponsor organisation address
    Hills Road, Cambridge, United Kingdom, CB2 0QQ
    Public contact
    Carrie Bayliss, Cambridge Unversity Hospitals NHS Foundation Trust, 44 01223348158, cctu@addenbrookes.nhs.uk
    Scientific contact
    Carrie Bayliss, Cambridge Unversity Hospitals NHS Foundation Trust, 44 01223348158, cctu@addenbrookes.nhs.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
    01 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine efficacy of ABX/GEM in downstaging “category 2” borderline unresectable locally advanced pancreatic cancer tumours sufficiently to enable resection.
    Protection of trial subjects
    The study was approved by a Research Ethics Committee and received authorisation from the Medicines and Healthcare Products Regulatory Authority. Patients received verbal and written information prior consenting to the trial, and had time to consider their participation and opportunity to ask questions. Consenting patients had a series of screening tests and exams to ensure they were suitable for the study and it was safe to proceed. Enrolment into the trial did not affect any aspect of the surgical treatment plan and each patient was treated according to local practice. On registration to the trial patients were allocated a unique reference number to be used on all data and samples sent to the sponsor, which allowed their personal data to remain anonymous. Only the patients direct care team had access to their recruited participants personal data during the trial. Patients could be withdrawn at any time, at the patient's request or at the clinician's decision. Adverse events were monitored on an ongoing basis, with end of study assessments performed approx 28-35 days after the end of study drug administration or post-surgery.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    12 Aug 2014
    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
    United Kingdom: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    4
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The sample size for the trial was a maximum of 17 evaluable patients. 9 patients were registered into the trial.

    Pre-assignment
    Screening details
    		 Patients aged >= 18 years with borderline unresectable advanced pancreatic adenocarcinoma, defined as Cat 2 by central radiological review, histological/cytological diagnosis, ECOG PS 0/1. A total of 23 patients consented to the trial, with 14 screen failures. The first patient was enrolled on 27 Aug 2014 and the last enrolled on 10 Apr 2017.

    Pre-assignment period milestones
    Number of subjects started
    		 23 [1]
    Number of subjects completed
    		 9

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Did not meet Inc/Exc criteria: 14
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Worldwide number enrolled in the trial is the number of consented subjects meeting inclusion/exclusion criteria and who were registered into the study to receive treatment. The number of subjects who started the pre-assignment period is the number of consented subjects screened for eligibility.
    Period 1
    Period 1 title
    On study
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Abraxane & Gemcitabine treatment
    Arm description
    		 Patients received Abraxane followed by Gemcitabine in combination for up to 6 cycles. Evaluation of resectability was performed after 3 cycles. If operable after 3 cycles, appropriate surgical intervention was undertaken. 1 further cycle of treatment could be administered whilst patients awaited surgery. If patients were considered unresectable after 3 cycles, a further 3 cycles of treatment was given before final re-evaluation of resectability. Patients received up to a maximum of 6 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abraxane
    Investigational medicinal product code
    Other name
    nab-paclitaxel
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Abraxane was administered at a dose of 125mg/m2 intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle, for a minimum of 3 cycles and a maximum of 6 cycles.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Gemzar
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine was administered at a dose of 1000mg/m2 intravenously over 30 minutes immediately after the completion of Abraxane administration on Days 1, 8 and 15 of each 28-day cycle. Patients received a minimum of 3 cycles and a maximum of 6 cycles.

    Number of subjects in period 1
    		Abraxane & Gemcitabine treatment
    Started
    9
    Completed
    9
    Period 2
    Period 2 title
    Post-Baseline
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Abraxane & Gemcitabine treatment
    Arm description
    		 Patients received Abraxane followed by Gemcitabine in combination for up to 6 cycles. Evaluation of resectability was performed after 3 cycles. If operable after 3 cycles, appropriate surgical intervention was undertaken. 1 further cycle of treatment could be administered whilst patients awaited surgery. If patients were considered unresectable after 3 cycles, a further 3 cycles of treatment was given before final re-evaluation of resectability. Patients received up to a maximum of 6 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abraxane
    Investigational medicinal product code
    Other name
    nab-paclitaxel
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Abraxane was administered at a dose of 125mg/m2 intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle, for a minimum of 3 cycles and a maximum of 6 cycles.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Gemzar
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine was administered at a dose of 1000mg/m2 intravenously over 30 minutes immediately after the completion of Abraxane administration on Days 1, 8 and 15 of each 28-day cycle. Patients received a minimum of 3 cycles and a maximum of 6 cycles.

    Number of subjects in period 2
    		Abraxane & Gemcitabine treatment
    Started
    9
    Completed
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    On study
    Reporting group description
    		 All enrolled subjects

    Reporting group values
    		 On study Total
    Number of subjects
    		 9 9
    Age categorical
    All enrolled subjects
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 65.5 (59.0 to 77.3) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 3 3
    Stage at Initial Diagnosis of PDAC
    Stage at Initial Diagnosis of Pancreatic Ductal Adenocarcinoma (PDAC)
    Units: Subjects
        II
    		 1 1
        IIB
    		 2 2
        III
    		 6 6
    ECOG PS
    ECOG Performance Status
    Units: Subjects
        PS 0
    		 5 5
        PS 1
    		 4 4
    CA19.9
    Units: U/ml
        median (full range (min-max))
    		 432.00 (165.00 to 1334.00) -
    Subject analysis sets

    Subject analysis set title
    Abraxane & Gemcitabine treatment (Evaluable)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Evaluable population is defined as patients who received at least 3 cycles and up to 6 cycles of protocol treatment or stopped protocol treatment early due to disease progression. The evaluable population is used for the analysis of the primary endpoint.

    Subject analysis sets values
    		 Abraxane & Gemcitabine treatment (Evaluable)
    Number of subjects
    9
    Age categorical
    All enrolled subjects
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    4
        From 65-84 years
    5
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    65.5 (59.0 to 77.3)
    Gender categorical
    Units: Subjects
        Female
    6
        Male
    3
    Stage at Initial Diagnosis of PDAC
    Stage at Initial Diagnosis of Pancreatic Ductal Adenocarcinoma (PDAC)
    Units: Subjects
        II
    1
        IIB
    2
        III
    6
    ECOG PS
    ECOG Performance Status
    Units: Subjects
        PS 0
    5
        PS 1
    4
    CA19.9
    Units: U/ml
        median (full range (min-max))
    432.00 (165.00 to 1334.00)

    End points

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    End points reporting groups
    Reporting group title
    Abraxane & Gemcitabine treatment
    Reporting group description
    		 Patients received Abraxane followed by Gemcitabine in combination for up to 6 cycles. Evaluation of resectability was performed after 3 cycles. If operable after 3 cycles, appropriate surgical intervention was undertaken. 1 further cycle of treatment could be administered whilst patients awaited surgery. If patients were considered unresectable after 3 cycles, a further 3 cycles of treatment was given before final re-evaluation of resectability. Patients received up to a maximum of 6 cycles.
    Reporting group title
    Abraxane & Gemcitabine treatment
    Reporting group description
    		 Patients received Abraxane followed by Gemcitabine in combination for up to 6 cycles. Evaluation of resectability was performed after 3 cycles. If operable after 3 cycles, appropriate surgical intervention was undertaken. 1 further cycle of treatment could be administered whilst patients awaited surgery. If patients were considered unresectable after 3 cycles, a further 3 cycles of treatment was given before final re-evaluation of resectability. Patients received up to a maximum of 6 cycles.

    Subject analysis set title
    Abraxane & Gemcitabine treatment (Evaluable)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Evaluable population is defined as patients who received at least 3 cycles and up to 6 cycles of protocol treatment or stopped protocol treatment early due to disease progression. The evaluable population is used for the analysis of the primary endpoint.

    Primary: Determination of resectability rate in “category 2” borderline unresectable locally advanced pancreatic cancer patients after up to 6 cycles of treatment with Abraxane and Gemcitabine as deemed by independent review

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    End point title
    		 Determination of resectability rate in “category 2” borderline unresectable locally advanced pancreatic cancer patients after up to 6 cycles of treatment with Abraxane and Gemcitabine as deemed by independent review
    End point description
    Evaluation of resectability occurred through central review of CT scans; patients enrolled on study with Category 2 tumours were only to be considered resectable if their CT scan confirmed change to Category 1 characteristics. Each assessment of operability was undertaken by at least two external observers from a pre-specified panel of surgeons and radiologists using a structured reporting system. All 9 enrolled subjects are in the Evaluable population, hence they are all included in the primary endpoint analysis. This is a single arm study, therefore there are no statistical comparisons. A total of 4/9 (44.4%) subjects were considered resectable by central radiological review at end of treatment (95% CI: 13.7%, 78.8%).
    End point type
    Primary
    End point timeframe
    If rendered operable after 3 or 6 cycles, appropriate surgical intervention was undertaken and patients went on to standard adjuvant therapy. For patients who were resectable after 3 cycles, 1 further cycle could be administered whilst awaiting surgery
    End point values
    		 Abraxane & Gemcitabine treatment Abraxane & Gemcitabine treatment (Evaluable)
    Number of subjects analysed
    9
    9
    Units: Subjects
        Resectable
    4
    4
        Non-Resectable
    5
    5
    Statistical analysis title
    		 resection rate
    Statistical analysis description
    single-armed estimate and 95% CI of resection rate
    Comparison groups
    Abraxane & Gemcitabine treatment v Abraxane & Gemcitabine treatment (Evaluable)
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 rate
    Point estimate
    0.444
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.137
         upper limit
    		 0.788
    Notes
    [1] - This is a single arm study, a total of 9 patients were enrolled. However the "Number of subjects included in analysis = 18" (two rows above) is an incorrect value, auto-generated which combines the "Reporting group" and "Subject analysis set".

    Secondary: Radiological response as determined by percentage change in sum of longest diameters for all target lesions at 3 or 6 months from the start of treatment

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    End point title
    		 Radiological response as determined by percentage change in sum of longest diameters for all target lesions at 3 or 6 months from the start of treatment
    End point description
    This is a single arm study, therefore there are no statistical comparisons. Summary statistics for Percentage Change from Baseline are presented.
    End point type
    Secondary
    End point timeframe
    Percentage change in the sum of the longest diameters for all target lesions at 3 or 6 months from start of ABX/GEM treatment.
    End point values
    		 Abraxane & Gemcitabine treatment (Evaluable)
    Number of subjects analysed
    9
    Units: mm
        median (full range (min-max))
    -14.3 (-46.7 to 0.0)
    No statistical analyses for this end point

    Secondary: Response assessment by RECIST 1.1 criteria using conventional computerised tomography (CT) or magnetic resonance imaging (MRI) measurements

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    End point title
    		 Response assessment by RECIST 1.1 criteria using conventional computerised tomography (CT) or magnetic resonance imaging (MRI) measurements
    End point description
    This is a single-arm study, therefore there are no statistical comparisons. Responder is defined as Overall response = CR or PR. A total of 3/9 (33.3%) subjects were considered an Overall Responder at end of treatment (95% CI: 7.5%, 70.1%).
    End point type
    Secondary
    End point timeframe
    Response Assessments (CR, PR, SD or PD) by RECIST 1.1 criteria at 3 or 6 months using conventional CT or MRI.
    End point values
    		 Abraxane & Gemcitabine treatment (Evaluable)
    Number of subjects analysed
    9
    Units: Subjects
        Responder (CR/PR)
    3
        Non-Responder (SD/PD/NE)
    6
    No statistical analyses for this end point

    Secondary: Biochemical response rate (serum CA19.9)

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    End point title
    		 Biochemical response rate (serum CA19.9)
    End point description
    This is a single-arm study, therefore there are no statistical comparisons. Evaluable subjects who have data at Baseline and End of Treatment visit are included. Summary statistics for Percentage Change from Baseline are presented.
    End point type
    Secondary
    End point timeframe
    Baseline is defined as the Day 1 Cycle 1 assessment. End of Treatment visit occurred 30 (28-35) days following end of treatment, or 30 (28-35) days following date of surgery for subjects undergoing surgery.
    End point values
    		 Abraxane & Gemcitabine treatment (Evaluable)
    Number of subjects analysed
    8
    Units: U/ml
        median (full range (min-max))
    -81.19 (-95.14 to -33.33)
    No statistical analyses for this end point

    Secondary: Operability Rate (Institution determined)

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    End point title
    		 Operability Rate (Institution determined)
    End point description
    Primary Endpoint of resectability after up to 6 cycles is based on independent central review. If local site assessment of disease at the Specialist Multi-Disciplinary Team contradicted the independent assessment such that local investigators decided an R0 resection was possible, this is captured in this secondary endpoint of operability rate. This is a single-arm study, therefore there are no statistical comparisons. A total of 5/9 (55.6%) subjects were considered resectable by local review at end of treatment (95% CI: 21.2%, 86.3%). Note that the LOCAL and CENTRAL review decisions differed for 3 subjects: 2 subjects were not considered resectable based on central review but were considered operable based on local review, and both underwent surgery; 1 subject was considered resectable based on central review but not considered operable based on local review, this subject underwent surgery. Therefore, a total of 6 subjects were actually considered eligible for surgery.
    End point type
    Secondary
    End point timeframe
    Operability rate is based on the local radiological review outcome after up to 6 cycles of ABX/GEM treatment.
    End point values
    		 Abraxane & Gemcitabine treatment (Evaluable)
    Number of subjects analysed
    9
    Units: Subjects
        Resectable
    5
        Non-resectable
    4
    No statistical analyses for this end point

    Secondary: Pathological down-staging and margin status after resection

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    End point title
    		 Pathological down-staging and margin status after resection
    End point description
    This is a single-arm study, therefore there are no statistical comparisons. The percentage of patients in each category of tumour destruction is presented. The categories range from Grade I (1%-9% of tumour necrosis) to Grade IV (absence of viable tumour cells), with an additional category of None (no tumour necrosis). Whilst 6 subjects initially underwent surgery, for one subject their surgery was unable to be performed (peritoneal deposits), and they have no histopathology report. Of the 5 subjects with Histopathology Report, 4 (80%) had resection margins involved.
    End point type
    Secondary
    End point timeframe
    As captured on Histopathology Report following Surgery.
    End point values
    		 Abraxane & Gemcitabine treatment (Evaluable)
    Number of subjects analysed
    5
    Units: Subjects
        Grade I (1%-9% of tumour necrosis)
    2
        Grade II (10%-90% of tumour necrosis)
    3
    No statistical analyses for this end point

    Secondary: Assessment of peri- and post-operative outcomes following surgery

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    End point title
    		 Assessment of peri- and post-operative outcomes following surgery
    End point description
    This is a single-arm study, therefore there are no statistical comparisons. Intra-operative complications were reported for 1 subject (prolonged procedure due to vascular involvement). Specific post-operative complications of Delayed gastric emptying / post-operative pancreatic fistula / post-operative pancreatic haemorrhage / any other post-operative complications were captured at the Surgery follow-up visit. There were none reported.
    End point type
    Secondary
    End point timeframe
    Intra-operative complications were captured on the Surgery CRF. Post-operative complications were reported at the Day of Surgery + 2-6 weeks visit.
    End point values
    		 Abraxane & Gemcitabine treatment (Evaluable)
    Number of subjects analysed
    6
    Units: Subjects
        Any Post-Op complications? No
    6
    No statistical analyses for this end point

    Secondary: 30-Day post-operative mortality

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    End point title
    		 30-Day post-operative mortality
    End point description
    This is a single-arm study, therefore there are no statistical comparisons. There were no deaths reported during the PRICKLE study, therefore this endpoint is not applicable.
    End point type
    Secondary
    End point timeframe
    Deaths reported within 30 days following surgery
    End point values
    		 Abraxane & Gemcitabine treatment (Evaluable)
    Number of subjects analysed
    6
    Units: Subjects
        30-Day post-op death? No
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    All Participants
    Reporting group description
    		 -

    Serious adverse events
    		 All Participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 9 (44.44%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Febrile neutropenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fever
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Biliary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All Participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    Vascular disorders
    Hot flashes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    3
    Hypotension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Phlebitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chills
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Edema limbs
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    5
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 9 (100.00%)
         occurrences all number
    41
    Fever
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 9 (55.56%)
         occurrences all number
    6
    Flu like symptoms
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    8
    General disorders - Other, rigor/shiver
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    General disorders and administration site conditions - Other, coryzal symptoms
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Malaise
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    4
    Dyspnea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    4
    Epistaxis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 9 (55.56%)
         occurrences all number
    6
    Laryngeal inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Postnasal drip
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    3
    Productive cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders - Other, mucositis nasal sores
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Sore throat
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Psychiatric disorders
    Depression
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Investigations
    Alanine aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 9 (66.67%)
         occurrences all number
    21
    Alkaline phosphatase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    17
    Aspartate aminotransaminase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Aspartate aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 9 (55.56%)
         occurrences all number
    10
    Blood bilirubin increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    8
    Investigations - Other, creactive protein increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Investigations - Other, leukocyte count decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Investigations - Other, leukocytes in urine
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Lymphocyte count decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    8
    Neutrophil count decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 9 (66.67%)
         occurrences all number
    16
    Pancreatic enzymes decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Platelet count decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    4
    Serum amylase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    4
    Weight loss
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    3
    White blood cell decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 9 (55.56%)
         occurrences all number
    9
    Injury, poisoning and procedural complications
    Fall
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Nervous system disorders
    Dysesthesia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Dysgeusia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 9 (66.67%)
         occurrences all number
    12
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    4
    Nervous system disorders - Other, migraine
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Nervous system disorders - Other, vivid dreams
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Peripheral motor neuropathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Peripheral sensory neuropathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Vasovagal reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    6
    Ear and labyrinth disorders
    Ear and labyrinth disorders - Other, dizziness and full sensation middle ear
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Ear pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Eye disorders
    Eye disorders - Other, cloudy eyes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Watering eyes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 9 (88.89%)
         occurrences all number
    15
    Bloating
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 9 (77.78%)
         occurrences all number
    14
    Diarrhea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 9 (100.00%)
         occurrences all number
    22
    Dry mouth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 9 (66.67%)
         occurrences all number
    6
    Dyspepsia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Fecal incontinence
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Flatulence
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Gastroesophageal reflux disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Gastrointestinal disorders - Other, eructation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Gastrointestinal disorders - Other, reflux oesophagitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Gastrointestinal disorders - Other, steatorrhea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Mucositis oral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    6
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 9 (88.89%)
         occurrences all number
    22
    Pancreatitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Rectal hemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 9 (66.67%)
         occurrences all number
    27
    Hepatobiliary disorders
    Cholecystitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Hepatobiliary disorders - Other, biliary stent obstruction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 9 (88.89%)
         occurrences all number
    16
    Dry skin
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 9 (55.56%)
         occurrences all number
    8
    Purpura
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Rash acneiform
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    4
    Rash maculo-papular
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 9 (77.78%)
         occurrences all number
    18
    Skin and subcutaneous tissue disorders - Other, erythema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders - Other, rosacea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Urticaria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Renal and urinary disorders
    Hematuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Proteinuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Renal and urinary disorders - Other, bacteriuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Renal and urinary disorders - Other, bilirubinuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Urinary frequency
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Urine discoloration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Myalgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    4
    Infections and infestations
    Hepatitis viral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Mucosal infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    4
    Soft tissue infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Upper respiratory infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Vaginal infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Anorexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 9 (77.78%)
         occurrences all number
    23
    Hypoalbuminemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Metabolism and nutrition disorders - Other, glucose in urine
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 9 (11.11%)
         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
    28 May 2015
    Safety & IMP updates following release of new Abraxane SmPC. Removal of SPARC analysis. Clarifications to procedures and assessment timing.
    07 Feb 2017
    Extension of the study by 12 months due to slower than expected recruitment.
    30 Jun 2017
    Protocol Reference Safety Information updated. Abraxane SmPC updates.

    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.
    N/A
    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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