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    Clinical Trial Results:
    To assess the safety of continuous IV administration of the CXCR4 antagonist, plerixafor (Mozobil), at potentially active plasma concentrations and assess its impact on the immune microenvironment in patients with advanced pancreatic, high grade serous ovarian and colorectal adenocarcinomas

    Summary
    EudraCT number
    		 2014-000117-31
    Trial protocol
    		 GB  
    Global end of trial date
    12 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAM-PLEX (A093446)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02179970
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cambridge University Hospitals NHS Trust and the University of Cambridge
    Sponsor organisation address
    Hills Road, Cambridge, United Kingdom, CB2 0QQ
    Public contact
    Mrs Carrie Bayliss, Cambridge University Hospitals NHS Trust and the University of Cambridge, cctu@addenbrookes.nhs.uk
    Scientific contact
    Professor Duncan Jodrell, CRUK Cambridge Institute, University of Cambridge, duncan.jodrell@cruk.cam.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 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary Objective To assess safety of continuous IV administration of plerixafor in doses needed to achieve and maintain circulating levels similar to those active in a murine model of PDAC (2 μg/ml) Secondary Objective To explore objective anticancer clinical impact of this strategy.
    Protection of trial subjects
    The study was approved by a Research Ethics Committee and received authorisation from the medicine and Healthcare Product Regulatory Authority. Patients received verbal and written information prior to consenting to the trial, and had time to consider their participation and opportunity to ask questions. Consenting patients had as series of screening test and to ensure they were suitable for the study and it was safe to proceed. On registration to the trial the participants were allocated a unique reference number that was to be used on all data and samples sent to the sponsor which allowed their personal data remain anonymous. Only the participants direct care team had access to their recruited participants personal data during the trial. Any patient information that was sent such a laboratory reports to confirm eligibility, which were sent to the coordinating center were anonymised and annotated with the trial reference number.
    Background therapy
    		 -
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    05 Jan 2015
    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 States: 2
    Country: Number of subjects enrolled
    United Kingdom: 24
    Worldwide total number of subjects
    26
    EEA total number of subjects
    24
    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)
    9
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The sample size for the trial was up to 28 patients who were to complete 7 days of treatment with Plerixafor. initially up to 18 patients were to be enrolled into the dose escalation phase, followed by a further 10 patients into the expansion phase of the trial. 26 participants were enrolled into the trial across 2 centres internationally.

    Pre-assignment
    Screening details
    		 34 patients were consented and assessed for eligibility. 18 patients were enrolled into the dose escalation phase of the trial and 8 enrolled into the treatment expansion phase. 8 patients were found not to meet the eligibility criteria, during the screening period.

    Pre-assignment period milestones
    Number of subjects started
    		 34 [1]
    Number of subjects completed
    		 26

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Non-eligibility: 8
    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: 34 patients were consented and assessed for eligibility, 8 patients were found not to meet the eligibility criteria, during the screening period.
    Period 1
    Period 1 title
    On Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dose level 20 ug/kg/hr
    Arm description
    		 Patient with inoperable, histologically proven locally advanced or metastatic pancreatic, high grade serous ovarian or colorectal adenocarcinoma, refractory to conventional chemotherapy or a patient who has declined conventional chemotherapy were enrolled into the dose escalation phase. Three (3) patients were to be entered into the trial sequentially per dose level using the standard 3+3 phase l trial design. The dose levels for the dose escalation phase started at 20 ug/kg/hr. The dose was to be escalated to the next sequential dose level (40, 80 or 120 μg/kg/hr) only after 3 patients completed the previous dose level, in the absence of a dose limiting toxicity (DLT) and as long as the primary objective had not been reached. All 3 patients completed the Day 28 follow-up visit for the dose level and there were no safety issues
    Arm type
    		 Experimental

    Investigational medicinal product name
    plerixafor
    Investigational medicinal product code
    GZ316455
    Other name
    Mozobil (AMD3100)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Plerixafor was to be given as a continuous 7 day IV infusion, starting at a dose of 20 ug/kg/hr. Plerixafor given as a continuous 7 day IV infusion, at a dose of 20 ug/kg/hr (as an inpatient for at least the initial 72 hours)..

    Arm title
    		 Dose level 40 ug/kg/hr
    Arm description
    		 Dose escalation level 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    plerixafor
    Investigational medicinal product code
    GZ316455
    Other name
    Mozobil (AMD3100)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Plerixafor was to be given as a continuous 7 day IV infusion, starting at a dose of 40 ug/kg/hr. Plerixafor given as a continuous 7 day IV infusion, at a dose of 40 ug/kg/hr (as an inpatient for at least the initial 72 hours).

    Arm title
    		 Dose level 80 ug/kg/hr
    Arm description
    		 Dose escalation level 3 During the treatment expansion phase patients with inoperable, histologically proven locally advanced or metastatic pancreatic, refractory to conventional chemotherapy or a patient who has declined conventional chemotherapy were enrolled in the treatment expansion phase of the trial up to 10 patients in total at this dose level which was evaluated at the RP2D determined in the dose escalation phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    plerixafor
    Investigational medicinal product code
    GZ316455
    Other name
    Mozobil (AMD3100)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Plerixafor was to be given as a continuous 7 day IV infusion, starting at a dose of 80 ug/kg/hr. Plerixafor given as a continuous 7 day IV infusion, at a dose of 80 ug/kg/hr (as an inpatient for at least the initial 72 hours).

    Arm title
    		 Dose level 120 ug/kg/hr
    Arm description
    		 Dose escalation level 4
    Arm type
    		 Experimental

    Investigational medicinal product name
    plerixafor
    Investigational medicinal product code
    GZ316455
    Other name
    Mozobil (AMD3100)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Plerixafor was to be given as a continuous 7 day IV infusion, starting at a dose of 120 ug/kg/hr. Plerixafor given as a continuous 7 day IV infusion, at a dose of 120 ug/kg/hr (as an inpatient for at least the initial 72 hours).

    Number of subjects in period 1
    		Dose level 20 ug/kg/hr Dose level 40 ug/kg/hr Dose level 80 ug/kg/hr Dose level 120 ug/kg/hr
    Started
    3
    5
    11
    7
    Completed
    3
    3
    10
    6
    Not completed
    0
    2
    1
    1
         Adverse event, non-fatal
    -
    2
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    On Study
    Reporting group description
    		 -

    Reporting group values
    		 On Study Total
    Number of subjects
    		 26 26
    Age categorical
    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)
    		 9 9
        From 65-84 years
    		 17 17
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 66.2 (49.7 to 75.9) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 17 17
    Site of Primary Cancer
    Units: Subjects
        Colorectal Adenocarcinoma
    		 15 15
        Ovarian Adenocarcinoma
    		 0 0
        Pancreatic Ductal Adenocarcinoma (PDAC)
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Dose level 20 ug/kg/hr
    Reporting group description
    		 Patient with inoperable, histologically proven locally advanced or metastatic pancreatic, high grade serous ovarian or colorectal adenocarcinoma, refractory to conventional chemotherapy or a patient who has declined conventional chemotherapy were enrolled into the dose escalation phase. Three (3) patients were to be entered into the trial sequentially per dose level using the standard 3+3 phase l trial design. The dose levels for the dose escalation phase started at 20 ug/kg/hr. The dose was to be escalated to the next sequential dose level (40, 80 or 120 μg/kg/hr) only after 3 patients completed the previous dose level, in the absence of a dose limiting toxicity (DLT) and as long as the primary objective had not been reached. All 3 patients completed the Day 28 follow-up visit for the dose level and there were no safety issues

    Reporting group title
    Dose level 40 ug/kg/hr
    Reporting group description
    		 Dose escalation level 2.

    Reporting group title
    Dose level 80 ug/kg/hr
    Reporting group description
    		 Dose escalation level 3 During the treatment expansion phase patients with inoperable, histologically proven locally advanced or metastatic pancreatic, refractory to conventional chemotherapy or a patient who has declined conventional chemotherapy were enrolled in the treatment expansion phase of the trial up to 10 patients in total at this dose level which was evaluated at the RP2D determined in the dose escalation phase.

    Reporting group title
    Dose level 120 ug/kg/hr
    Reporting group description
    		 Dose escalation level 4

    Primary: Safety and tolerability

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    End point title
    		 Safety and tolerability [1]
    End point description
    Grading according to NCI CTCAE v. 4.03
    End point type
    Primary
    End point timeframe
    Adverse events were reported from informed consent and throughout treatment and follow up to resolution.
    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: No statistical analyses to compare between the groups have been performed as this end point is not powered to compare the different dose levels. No DLTs were reported in the first 3 dose levels of the dose escalation phase. At the highest dose level (120µg/kg/hr), 2 DLTs were recorded. Therefore, the previous dose level (80µg/kg/hr) was selected for the expansion phase, recruiting patients with pancreatic adenocarcinomas only. Therefore, the first primary endpoint was achieved.
    End point values
    		 Dose level 20 ug/kg/hr Dose level 40 ug/kg/hr Dose level 80 ug/kg/hr Dose level 120 ug/kg/hr
    Number of subjects analysed
    3 [2]
    4 [3]
    11 [4]
    7 [5]
    Units: total number
    number (not applicable)
        Number of grade 3 and above Adverse events
    0
    2
    12
    13
        Number of grade 1-2 Adverse events reported
    40
    60
    213
    172
    Notes
    [2] - Out of the Grade 1-2 Adverse Events reported, 3 events were adverse events of special interest
    [3] - 1 patient did not receive IMP; 3 G+, and 5 G1-2 AEs reported; 3 events were AESIs
    [4] - Out of the Grade 1-2 Adverse Events reported, 21 events were AESI
    [5] - Out of the Grade 3 and above AEs reported, 2 events were DLTs and 13 of the grade 1-2 were AESIs
    No statistical analyses for this end point

    Primary: Css - PK concentration

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    End point title
    		 Css - PK concentration [6]
    End point description
    Measurement of plerixafor concentration in plasma at 3 time points (days 2, 4 and 8), during the continuous i.v. infusion.
    End point type
    Primary
    End point timeframe
    The plasma pharmacokinetics of plerixafor in patients with cancer. Css ≥2 µg/ml should be achieved in ≥80% of patients treated at the RP2D. PKs assessed on research blood samples collected during treatment on day 2, day 4, day 8 and day 13-17.
    Notes
    [6] - 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: No statistical analyses for this end point as this was a laboratory analyses related endpoint that determined the concentration of the drug. This did not meet the second primary endpoint (≥80% of patients achieving a plasma concentration of >2µg/ml), but emerging pharmacodynamic data suggested no incremental dose response above 40µg/kg/hr.
    End point values
    		 Dose level 20 ug/kg/hr Dose level 40 ug/kg/hr Dose level 80 ug/kg/hr Dose level 120 ug/kg/hr
    Number of subjects analysed
    3
    4 [7]
    10 [8]
    4 [9]
    Units: microgram(s)
    arithmetic mean (standard deviation)
        Concentration a Day 2
    0.339 ± 0.0370
    0786 ± 0.176
    1.69 ± 0.507
    2.38 ± 0.364
        Concentration at Day 4
    0.499 ± 0.0473
    0.940 ± 0.165
    2.21 ± 0.756
    3.54 ± 1.235
        Concentration at Day 8
    0.584 ± 0.0194
    1.015 ± 0.291
    2.28 ± 0.886
    2.99 ± 0.804
    Notes
    [7] - 1 patient was withdrawn on day 7
    [8] - 1 patient withdrawn by Day 7; 7/11 (64%) patients achieved a plasma concentration >2µg/ml
    [9] - 3 patients withdrawn by day 7; 4 patients achieved a plasma Css >2µg/ml (range 2.38-4.16µg/ml).
    No statistical analyses for this end point

    Secondary: Objective data on disease status to assess response at Day 28

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    End point title
    		 Objective data on disease status to assess response at Day 28
    End point description
    Contrast enhance CT scan and RECIST 1.1
    End point type
    Secondary
    End point timeframe
    Assessed on day 20-24
    End point values
    		 Dose level 20 ug/kg/hr Dose level 40 ug/kg/hr Dose level 80 ug/kg/hr Dose level 120 ug/kg/hr
    Number of subjects analysed
    3
    4 [10]
    11
    6 [11]
    Units: Overall response
    number (not applicable)
        Complete reponse
    0
    0
    0
    0
        Partial reponse
    0
    0
    0
    0
        Stable disease
    2
    3
    4
    5
        progressive disease
    1
    1
    7
    1
    Notes
    [10] - 1 patient did not start treatment therefore not evaluable
    [11] - 1 patient withdrawn therefore not evaluable
    No statistical analyses for this end point

    Secondary: Metabolic changes in tumour using FDG-PET

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    End point title
    		 Metabolic changes in tumour using FDG-PET
    End point description
    FDG-PET/CT scans were performed during the screening period and on Day 8, after the core tissue biopsy. Paired PET-CT scans were evaluable in 19 patients (12 escalation phase, 7 expansion phase). Of these, 11 patients had CRC and 8 PDAC). Clinically significant (defined as delta SUV MWA ≥ 30%) changes were seen in 2 patients. Two patients (CRC, 40 µg/kg/hr) had a ≥30% increase in SUV MWA (71% and 32%).
    End point type
    Secondary
    End point timeframe
    Assessment of metabolic changes in tumour using non-invasive imaging (18FDG-PET). An FDG-PET/CT was assessed on day 8 and compare to pre-treatment to generate a delta SUVMWA value (%).
    End point values
    		 Dose level 20 ug/kg/hr Dose level 40 ug/kg/hr Dose level 80 ug/kg/hr Dose level 120 ug/kg/hr
    Number of subjects analysed
    2 [12]
    3 [13]
    5 [14]
    5 [15]
    Units: percent weight/weight
    number (not applicable)
        ≥30% increase in SUVMWA
    0
    2
    0
    0
        ≥30% decrease in SUVMWA
    0
    0
    0
    0
    Notes
    [12] - Mean Delta SUV -6.7%
    [13] - MeanDelta SUVMWA +38.7%
    [14] - MeanDelta SUVMWA -3.30%
    [15] - MeanDelta SUVMWA -9.70%
    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
    26 patients had adverse events reported, however 1 patient did not receive any IMP they had 8 events reported, one of which was a serious adverse event.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 25 (48.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Hypertension
    Additional description: Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thromboembolic event
    Additional description: Thromboembolic event
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Vasovagal reaction
    Additional description: Vasovagal reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anemia
    Additional description: Anemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Duodenal obstruction
    Additional description: Duodenal obstruction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastritis
    Additional description: Gastritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatobiliary disorders - Other, biliary tract obstr
    Additional description: Hepatobiliary disorders - Other, biliary tract obstr
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders - Other, obstruction of intr
    Additional description: Hepatobiliary disorders - Other, obstruction of intr
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Psychiatric disorders - Other, panic attack
    Additional description: Psychiatric disorders - Other, panic attack
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Biliary tract infection
    Additional description: Biliary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
    Additional description: Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         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
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 25 (100.00%)
    Vascular disorders
    Flushing
    Additional description: Flushing
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Hot flashes
    Additional description: Hot flashes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 25 (32.00%)
         occurrences all number
    9
    Hypertension
    Additional description: Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Hypotension
    Additional description: Hypotension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    General disorders and administration site conditions
    Chills
    Additional description: Chills
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    2
    Fatigue
    Additional description: Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 25 (40.00%)
         occurrences all number
    14
    Fever
    Additional description: Fever
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 25 (28.00%)
         occurrences all number
    11
    Non-cardiac chest pain
    Additional description: Non-cardiac chest pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Pelvic pain
    Additional description: Pelvic pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Dyspnea
    Additional description: Dyspnea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Hiccups
    Additional description: Hiccups
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Hoarseness
    Additional description: Hoarseness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Pleural effusion
    Additional description: Pleural effusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders - Ot
    Additional description: Respiratory, thoracic and mediastinal disorders - Ot
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
    Additional description: Anxiety
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Confusion
    Additional description: Confusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Insomnia
    Additional description: Insomnia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    18 / 25 (72.00%)
         occurrences all number
    22
    Psychiatric disorders - Other, claustrophobia
    Additional description: Psychiatric disorders - Other, claustrophobia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Investigations
    Activated partial thromboplastin time prolonged
    Additional description: Activated partial thromboplastin time prolonged
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 25 (40.00%)
         occurrences all number
    14
    Alkaline phosphatase increased
    Additional description: Alkaline phosphatase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    14 / 25 (56.00%)
         occurrences all number
    16
    Blood bilirubin increased
    Additional description: Blood bilirubin increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    4
    Creatinine increased
    Additional description: Creatinine increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Electrocardiogram QT corrected interval prolonged
    Additional description: Electrocardiogram QT corrected interval prolonged
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    5
    INR increased
    Additional description: INR increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 25 (20.00%)
         occurrences all number
    5
    Investigations - Other, CRP increased
    Additional description: Investigations - Other, CRP increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Investigations - Other, eosinophil count increased
    Additional description: Investigations - Other, eosinophil count increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    15 / 25 (60.00%)
         occurrences all number
    18
    Investigations - Other, monocyte count increased
    Additional description: Investigations - Other, monocyte count increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    21 / 25 (84.00%)
         occurrences all number
    22
    Investigations - Other, neutrophil count increased
    Additional description: Investigations - Other, neutrophil count increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    22 / 25 (88.00%)
         occurrences all number
    26
    Investigations - Other, prothrombin time increased
    Additional description: Investigations - Other, prothrombin time increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Investigations - Other, white blood cell count incre
    Additional description: Investigations - Other, white blood cell count incre
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Lymphocyte count decreased
    Additional description: Lymphocyte count decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    7
    Lymphocyte count increased
    Additional description: Lymphocyte count increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 25 (20.00%)
         occurrences all number
    5
    Platelet count decreased
    Additional description: Platelet count decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 25 (20.00%)
         occurrences all number
    6
    Injury, poisoning and procedural complications
    Bruising
    Additional description: Bruising
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    4
    Injury, poisoning and procedural complications - Oth
    Additional description: Injury, poisoning and procedural complications - Oth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Cardiac disorders
    Atrial fibrillation
    Additional description: Atrial fibrillation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Atrioventricular block first degree
    Additional description: Atrioventricular block first degree
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Cardiac disorders - Other, intraventricular conducti
    Additional description: Cardiac disorders - Other, intraventricular conducti
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Cardiac disorders - Other, left axis deviation
    Additional description: Cardiac disorders - Other, left axis deviation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Cardiac disorders - Other, multifocal atrial tachyca
    Additional description: Cardiac disorders - Other, multifocal atrial tachyca
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Cardiac disorders - Other, right bundle branch block
    Additional description: Cardiac disorders - Other, right bundle branch block
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Cardiac disorders - Other, supraventricular arrhythm
    Additional description: Cardiac disorders - Other, supraventricular arrhythm
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Cardiac disorders - Other, supraventricular ectopics
    Additional description: Cardiac disorders - Other, supraventricular ectopics
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Palpitations
    Additional description: Palpitations
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Sinus bradycardia
    Additional description: Sinus bradycardia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Sinus tachycardia
    Additional description: Sinus tachycardia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Supraventricular tachycardia
    Additional description: Supraventricular tachycardia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Ventricular arrhythmia
    Additional description: Ventricular arrhythmia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    4
    Nervous system disorders
    Dizziness
    Additional description: Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Dysgeusia
    Additional description: Dysgeusia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Headache
    Additional description: Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    6
    Nervous system disorders - Other, abnormal dreams
    Additional description: Nervous system disorders - Other, abnormal dreams
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Nervous system disorders - Other, nightmare/ abnorma
    Additional description: Nervous system disorders - Other, nightmare/ abnorma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Nervous system disorders - Other, vivid dreams
    Additional description: Nervous system disorders - Other, vivid dreams
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Nervous system disorders - Other, vivid dreams/flash
    Additional description: Nervous system disorders - Other, vivid dreams/flash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Paresthesia
    Additional description: Paresthesia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    15 / 25 (60.00%)
         occurrences all number
    19
    Peripheral sensory neuropathy
    Additional description: Peripheral sensory neuropathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    2
    Presyncope
    Additional description: Presyncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Tremor
    Additional description: Tremor
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
    Additional description: Anemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 25 (44.00%)
         occurrences all number
    17
    Eye disorders
    Watering eyes
    Additional description: Watering eyes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal distension
    Additional description: Abdominal distension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Abdominal pain
    Additional description: Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 25 (52.00%)
         occurrences all number
    19
    Ascites
    Additional description: Ascites
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Constipation
    Additional description: Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Diarrhea
    Additional description: Diarrhea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    15 / 25 (60.00%)
         occurrences all number
    18
    Dry mouth
    Additional description: Dry mouth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Duodenal obstruction
    Additional description: Duodenal obstruction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Flatulence
    Additional description: Flatulence
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Gastrointestinal disorders - Other, aphthous ulcer
    Additional description: Gastrointestinal disorders - Other, aphthous ulcer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Mucositis oral
    Additional description: Mucositis oral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Nausea
    Additional description: Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 25 (40.00%)
         occurrences all number
    15
    Vomiting
    Additional description: Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 25 (36.00%)
         occurrences all number
    11
    Hepatobiliary disorders
    Hepatic pain
    Additional description: Hepatic pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 25 (24.00%)
         occurrences all number
    12
    Hepatobiliary disorders - Other, hyperbilirubinaemia
    Additional description: Hepatobiliary disorders - Other, hyperbilirubinaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dry skin
    Additional description: Dry skin
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Pruritus
    Additional description: Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Renal and urinary disorders
    Proteinuria
    Additional description: Proteinuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    14 / 25 (56.00%)
         occurrences all number
    24
    Musculoskeletal and connective tissue disorders
    Back pain
    Additional description: Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorder - Oth
    Additional description: Musculoskeletal and connective tissue disorder - Oth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders - Ot
    Additional description: Musculoskeletal and connective tissue disorders - Ot
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Neck pain
    Additional description: Neck pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Infections and infestations
    Biliary tract infection
    Additional description: Biliary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Infections and infestations - Other, gastroenteritis
    Additional description: Infections and infestations - Other, gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Infections and infestations - Other, oral candidiasi
    Additional description: Infections and infestations - Other, oral candidiasi
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Mucosal infection
    Additional description: Mucosal infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Upper respiratory infection
    Additional description: Upper respiratory infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Urinary tract infection
    Additional description: Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Anorexia
    Additional description: Anorexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 25 (20.00%)
         occurrences all number
    7
    Hypercalcemia
    Additional description: Hypercalcemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Hypoalbuminemia
    Additional description: Hypoalbuminemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    18 / 25 (72.00%)
         occurrences all number
    44
    Hypoglycemia
    Additional description: Hypoglycemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    2
    Hypokalemia
    Additional description: Hypokalemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 25 (28.00%)
         occurrences all number
    8
    Hyponatremia
    Additional description: Hyponatremia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    4
    Hypophosphatemia
    Additional description: Hypophosphatemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Dec 2015
    The United States sponsored participating site (Weill Cornell) was added to the study therefore the protocol was amended to reflect this. Other changes to the protocol and/or patient information sheet included; - Addition of routine blood sampling to the Day 13-17 and Day 20-24 visits for safety monitoring. - Clarification of CT scan type. - Clarification of patient discharge criteria. - Removal of ECOG on days 2, 3, 4, 5, 6 & 7. - Removal of urinalysis on days 3, 5, 6 & 7. - Clarification of cardiac events as an AE. - Updates to AESI terms. - Updates to SAE/AESI reporting guidelines. This amendment was submitted to both REC and MHRA.
    03 Feb 2016
    The protocol and patient information updated to increase duration of telemetry monitoring from 48 hours to 72 hours, this amendment also Incorporated increasing the time the patient was an in-patient for 48 hours to 72 hours to allow for the extended telemetry monitoring and vital signs. The protocol were also updated to include additional PK sample and blood volumes updated on the patient information sheet. This amendment submitted to REC.
    29 Nov 2016
    changes made to the protocol and/or patient information sheet to add or clarify the following: - Addition of saliva samples for cortisol measurement. - Screening lymphocyte count changed from ‘normal level for institution’ to ‘<1.0 x 10^9/L’. - Clarification of IMP interruption and stopping criteria. - Clarification of research sample types. - Informed consent timeframe of 21 days added. - Sanofi PV details removed from protocol as per Sanofi request. Information included in contract only. This amendment was submitted to both REC and MHRA
    24 May 2017
    The protocol Reference Safety Information section was amended to align with the MHRA process for reference safety information management, the added reference to the latest approved SmPC for Mozobil. The amendment includes changes to the CTA documentation, so therefore the amendment was also submitted to the MHRA. The MHRA werel also be notified of the new RSI for this trial as part of the amendment.
    18 Oct 2017
    Amendment submitted to notify the HRA and REC that the IMP supply arrangements had been modified. This amendment was also submitted to the MHRA for their approval. Penn Pharmaceuticals (PCI Pharma Services) were previously the importer of the finished product were also to be used for secondary packaging and labelling of the licenced IMP. Penn Pharmaceuticals (PCI Pharma Services were then responsible for QP certification. Genzyme CPRS no longer performed secondary packaging and labelling.
    11 Dec 2017
    plerixafor (Mozobil) SmPC text revised and the safety section updated, therefore changes made on the safety sections of the protocol and the side effects in the patient information sheet updated to reflect changes on the SmPC.

    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.
    Decision to close recruitment early was made as recruitment was slower than expected and although the recruitment target were not met, upon review of the data collected, it was determined that there was sufficient data to answer the trial objectives
    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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