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    Clinical Trial Results:
    A Multicenter Phase 2 Study of Single-agent Filanesib (ARRY-520) in Patients With Advanced Multiple Myeloma

    Summary
    EudraCT number
    		 2014-001051-23
    Trial protocol
    		 GB   DE   ES   GR   BE   FR  
    Global end of trial date
    12 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2018
    First version publication date
    06 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ARRAY-520-215
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02092922
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Array BioPharma Inc.
    Sponsor organisation address
    3200 Walnut Street, Boulder, Colorado, United States, 80301
    Public contact
    Teri Whisenand, Array BioPharma Inc., 001 3033861141, teri.whisenand@arraybiopharma.com
    Scientific contact
    Teri Whisenand, Array BioPharma Inc., 001 3033861141, teri.whisenand@arraybiopharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Estimate the objective response rate (ORR) for patients with low Baseline alpha 1-acid glycoprotein (AAG)
    Protection of trial subjects
    Approval by the medical ethics committee (EC) and competent authority. Participation in the study was voluntary and subject to the required patient information and informed consent procedures approved by the EC. Strict in- and exclusion criteria to assure exclusion of vulnerable participants. GCP trained staff.
    Background therapy
    		 Filgrastim prophylaxis: Administered as a single daily subcutaneous (SC) bolus injection per the local product prescribing information and institutional guidelines, starting on Day 3 and on Day 17 (each time for a total of 5 to 7 days). Prophylactic filgrastim allows the administration of higher filanesib doses, providing management of the hematologic effects associated with filanesib exposure and prevention of their complications.
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    16 Apr 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
    Spain: 13
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Germany: 28
    Country: Number of subjects enrolled
    Greece: 7
    Country: Number of subjects enrolled
    United States: 67
    Country: Number of subjects enrolled
    Canada: 7
    Worldwide total number of subjects
    154
    EEA total number of subjects
    80
    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)
    69
    From 65 to 84 years
    85
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Period: 16 April 2014 to 28 July 2015 Territory: Belgium, Canada, France, Germany, Greece, Spain, United Kingdom, United States

    Pre-assignment
    Screening details
    		 Screening evaluation included: Obtain written informed consent, record current and past medical history along with all transfusions/plasmaphereses administered, collect histopathologic confirmation of the diagnosis of multiple myeloma, record all prior treatments for multiple myeloma. A total of 215 subjects were screened

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

    Arms
    Arm title
    		 Filanesib 1.5 mg/m2/day
    Arm description
    		 Filanesib 1.5 mg/m2/day administered IV as a 1-hour (± 10-minute) infusion on Days 1, 2, 15 and 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filanesib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Per 28-day cycle: 1.5 mg/m2/day administered IV as a 1-hour (± 10-minute) infusion on Days 1, 2, 15 and 16.

    Number of subjects in period 1
    		Filanesib 1.5 mg/m2/day
    Started
    154
    Completed
    151
    Not completed
    3
         Subjects not treated
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 154 154
    Age categorical
    Age group
    Units: Subjects
        Adults (18-64 years)
    		 69 69
        From 65-84 years
    		 85 85
        85 years and over
    		 0 0
    Gender categorical
    Gender
    Units: Subjects
        Female
    		 63 63
        Male
    		 91 91
    Subject analysis sets

    Subject analysis set title
    Intent-to-treat Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) Set included all patients who were enrolled for treatment.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set (SS) included all patients who received 1 or more doses of filanesib.

    Subject analysis set title
    Response Evaluable Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Response Evaluable Set (RES) included all patients in the SS who had at least 1 post-Baseline disease assessment or who discontinued from the study due to progressive disease (PD), AE or death prior to any disease assessment. Patients whose disease at Baseline was not measurable or was not refractory to prior cancer treatments per protocol, and patients with other key protocol deviations may have been excluded from this set.

    Subject analysis set title
    QTc Substudy Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The PK/QTc Substudy Set included all patients enrolled in the PK/QTc substudy who had at least 1 blood collection for PK with associated bioanalytical results and for whom at least 1 ECG result was obtained.

    Subject analysis sets values
    		 Intent-to-treat Set Safety Set Response Evaluable Set QTc Substudy Set
    Number of subjects
    154
    151
    145
    14
    Age categorical
    Age group
    Units: Subjects
        Adults (18-64 years)
    69
        From 65-84 years
    85
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Gender
    Units: Subjects
        Female
    63
        Male
    91

    End points

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    End points reporting groups
    Reporting group title
    Filanesib 1.5 mg/m2/day
    Reporting group description
    		 Filanesib 1.5 mg/m2/day administered IV as a 1-hour (± 10-minute) infusion on Days 1, 2, 15 and 16.

    Subject analysis set title
    Intent-to-treat Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) Set included all patients who were enrolled for treatment.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set (SS) included all patients who received 1 or more doses of filanesib.

    Subject analysis set title
    Response Evaluable Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Response Evaluable Set (RES) included all patients in the SS who had at least 1 post-Baseline disease assessment or who discontinued from the study due to progressive disease (PD), AE or death prior to any disease assessment. Patients whose disease at Baseline was not measurable or was not refractory to prior cancer treatments per protocol, and patients with other key protocol deviations may have been excluded from this set.

    Subject analysis set title
    QTc Substudy Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The PK/QTc Substudy Set included all patients enrolled in the PK/QTc substudy who had at least 1 blood collection for PK with associated bioanalytical results and for whom at least 1 ECG result was obtained.

    Primary: ORR in patients with low Baseline AAG

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    End point title
    		 ORR in patients with low Baseline AAG [1]
    End point description
    The ORR was calculated for each AAG subset (Low AAG, High AAG, Unknown AAG) and for all patients in the ITT Set as the proportion of patients whose overall best response by Independent Review (IR) was sCR, CR, very good partial response (VGPR) or partial response (PR). A 95% confidence interval (CI) for each ORR was calculated based on exact binomial distributions.
    End point type
    Primary
    End point timeframe
    Blood and/or urine disease assessments are to be performed approximately every 28 days during the treatment period (on Day 1 ± 4 days of each cycle after Cycle 1).
    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 for this end point
    End point values
    		 Intent-to-treat Set Response Evaluable Set
    Number of subjects analysed
    121
    116
    Units: Subjects
        number (not applicable)
    9
    9
    No statistical analyses for this end point

    Secondary: ORR in patients with high Baseline AAG

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    End point title
    		 ORR in patients with high Baseline AAG
    End point description
    The ORR was calculated for each AAG subset (Low AAG, High AAG, Unknown AAG) and for all patients in the ITT Set as the proportion of patients whose overall best response by Independent Review (IR) was sCR, CR, very good partial response (VGPR) or partial response (PR). A 95% confidence interval (CI) for each ORR was calculated based on exact binomial distributions.
    End point type
    Secondary
    End point timeframe
    Blood and/or urine disease assessments are to be performed approximately every 28 days during the treatment period (on Day 1 ± 4 days of each cycle after Cycle 1).
    End point values
    		 Intent-to-treat Set Response Evaluable Set
    Number of subjects analysed
    26
    25
    Units: Subjects
        number (not applicable)
    1
    1
    No statistical analyses for this end point

    Secondary: Duration of Best Response of sCR, CR, VGPR, or PR

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    End point title
    		 Duration of Best Response of sCR, CR, VGPR, or PR
    End point description
    Duration of response is calculated for all patients achieving a sCR, CR, VGPR or PR and is defined as the time from first objective status assessment of sCR/CR/VGPR/PR to the time of first documented disease progression or death. A patient who initiates subsequent myeloma therapy after filanesib discontinuation and before documented disease progression will be censored at the last evaluable disease assessment prior to the start of the subsequent therapy. If a patient has not progressed, died or received subsequent myeloma therapy, the DOR will be censored on the day of the last evaluable disease assessment.
    End point type
    Secondary
    End point timeframe
    Blood and/or urine disease assessments are to be performed approximately every 28 days during the treatment period (on Day 1 ± 4 days of each cycle after Cycle 1).
    End point values
    		 Intent-to-treat Set
    Number of subjects analysed
    10
    Units: months
        median (full range (min-max))
    6.7 (1 to 11.5)
    Attachments
    		 Kaplan-Meier Plot Duration of Duration of Best Res
    No statistical analyses for this end point

    Secondary: Time to Best Response (TBR) of sCR, CR, VGPR, or PR

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    End point title
    		 Time to Best Response (TBR) of sCR, CR, VGPR, or PR
    End point description
    Time to response for patients achieving a sCR, CR, VGPR or PR is defined as the time from first filanesib infusion to the time of first objective status assessment of sCR/CR/VGPR/PR
    End point type
    Secondary
    End point timeframe
    Blood and/or urine disease assessments are to be performed approximately every 28 days during the treatment period (on Day 1 ± 4 days of each cycle after Cycle 1).
    End point values
    		 Intent-to-treat Set
    Number of subjects analysed
    10
    Units: months
        median (full range (min-max))
    4.2 (1 to 12.9)
    Attachments
    		 Kaplan-Meier Plot Time to Best Response of sCR, CR
    No statistical analyses for this end point

    Secondary: Time to Best Response (TBR) of MR

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    End point title
    		 Time to Best Response (TBR) of MR
    End point description
    Time to response for patients achieving an MR is defined as the time from first filanesib infusion to the time of first objective status assessment of MR.
    End point type
    Secondary
    End point timeframe
    Blood and/or urine disease assessments are to be performed approximately every 28 days during the treatment period (on Day 1 ± 4 days of each cycle after Cycle 1).
    End point values
    		 Intent-to-treat Set
    Number of subjects analysed
    7
    Units: months
        median (full range (min-max))
    4.4 (1.1 to 9)
    Attachments
    		 Kaplan-Meier Plot Time to Best Response of MR
    No statistical analyses for this end point

    Secondary: Clinical Benefit Rate (CBR)

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    End point title
    		 Clinical Benefit Rate (CBR)
    End point description
    Clinical benefit rate is defined as the proportion of patients who achieve ORR or MR (i.e., sCR, CR, VGPR, PR or MR).
    End point type
    Secondary
    End point timeframe
    Blood and/or urine disease assessments are to be performed approximately every 28 days during the treatment period (on Day 1 ± 4 days of each cycle after Cycle 1).
    End point values
    		 Intent-to-treat Set Response Evaluable Set
    Number of subjects analysed
    154
    145
    Units: Subjects
        number (not applicable)
    17
    17
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR)

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    End point title
    		 Disease Control Rate (DCR)
    End point description
    The disease control rate (DCR) was calculated for each AAG subset and for all patients as the proportion of patients who achieved a best overall response by IR of sCR, CR, VGPR, PR, MR or stable disease (SD) ≥ 8 weeks in duration; 95% CIs calculated for ORR and DCR were based on exact binomial distributions.
    End point type
    Secondary
    End point timeframe
    Blood and/or urine disease assessments are to be performed approximately every 28 days during the treatment period (on Day 1 ± 4 days of each cycle after Cycle 1).
    End point values
    		 Intent-to-treat Set Response Evaluable Set
    Number of subjects analysed
    154
    145
    Units: Subjects
        number (not applicable)
    27
    26
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

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    End point title
    		 Progression-Free Survival (PFS)
    End point description
    Progression-free survival is defined as the time from first filanesib infusion to the first documented disease progression or death due to any cause. The date of progression can be the date of PD (for patients not meeting sCR/CR criteria), relapse from sCR/CR if meeting the criteria for progression, or clinical progression. A patient who initiates subsequent myeloma therapy after filanesib discontinuation and before documented disease progression will be censored at the last evaluable disease assessment prior to the start of the subsequent therapy. If a patient has not progressed, died or received subsequent myeloma therapy, the PFS will be censored on the day of the last evaluable disease assessment. Median PFS and approximate 95% confidence intervals are estimated using Kaplan-Meier PFS techniques.
    End point type
    Secondary
    End point timeframe
    Time from first filanesib infusion to the first documented disease progression or death due to any cause
    End point values
    		 Intent-to-treat Set Intent-to-treat Set
    Number of subjects analysed
    154
    154
    Units: months
        median (full range (min-max))
    2.1 (0 to 15.2)
    2.1 (0 to 15.2)
    Attachments
    		 Kaplan-Meier Plot of progression-free survival
    No statistical analyses for this end point

    Secondary: Time to Next Treatment (TNT)

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    End point title
    		 Time to Next Treatment (TNT)
    End point description
    Time to next treatment is calculated for all patients and is defined as the time from first filanesib infusion to the time of first subsequent documented myeloma therapy. Patients who have not received subsequent therapy at the time of this analysis (end of study) have been censored at the date of last contact or death due to any cause. Median TNT and approximate 95% confidence intervals are estimated using Kaplan-Meier PFS techniques.
    End point type
    Secondary
    End point timeframe
    Time from first filanesib infusion to the time of first subsequent documented myeloma therapy
    End point values
    		 Intent-to-treat Set
    Number of subjects analysed
    254
    Units: months
        median (full range (min-max))
    3.3 (0 to 15.4)
    Attachments
    		 Kaplan-Meier Plot of time to next treatment (TNT)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial period
    Adverse event reporting additional description
    All subjects who were enrolled in the study and received at least one dose of study drug were included in the Safety Set
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Filanesib 1.5 mg/m2/day
    Reporting group description
    		 Filanesib 1.5 mg/m2/day administered IV as a 1-hour (± 10-minute) infusion on Days 1, 2, 15 and 16.

    Serious adverse events
    		 Filanesib 1.5 mg/m2/day
    Total subjects affected by serious adverse events
         subjects affected / exposed
    43 / 151 (28.48%)
         number of deaths (all causes)
    16
         number of deaths resulting from adverse events
    6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Platelet count decreased
         subjects affected / exposed
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urine output decreased
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wrong drug administered
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    3 / 151 (1.99%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure
         subjects affected / exposed
    3 / 151 (1.99%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    1 / 2
    Myocardial ischaemia
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Spinal cord compression
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    6 / 151 (3.97%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Haematopoietic thrombocytopenia
         subjects affected / exposed
    3 / 151 (1.99%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Anaemia
         subjects affected / exposed
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic haemorrhage
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis bullous
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    3 / 151 (1.99%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    Renal failure
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal pain
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    7 / 151 (4.64%)
         occurrences causally related to treatment / all
    3 / 8
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    4 / 151 (2.65%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    1 / 1
    Septic shock
         subjects affected / exposed
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Aspergillus infection
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningococcal sepsis
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenic infection
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenic colitis
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Filanesib 1.5 mg/m2/day
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    106 / 151 (70.20%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    17 / 151 (11.26%)
         occurrences all number
    17
    Neutrophil count decreased
         subjects affected / exposed
    14 / 151 (9.27%)
         occurrences all number
    14
    Platelet count decreased
         subjects affected / exposed
    23 / 151 (15.23%)
         occurrences all number
    23
    Weight decreased
         subjects affected / exposed
    14 / 151 (9.27%)
         occurrences all number
    14
    White blood cell count decreased
         subjects affected / exposed
    12 / 151 (7.95%)
         occurrences all number
    12
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 151 (5.96%)
         occurrences all number
    9
    Hypotension
         subjects affected / exposed
    9 / 151 (5.96%)
         occurrences all number
    9
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 151 (9.93%)
         occurrences all number
    15
    Dysgeusia
         subjects affected / exposed
    8 / 151 (5.30%)
         occurrences all number
    8
    Dizziness
         subjects affected / exposed
    7 / 151 (4.64%)
         occurrences all number
    7
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    43 / 151 (28.48%)
         occurrences all number
    43
    Anaemia
         subjects affected / exposed
    72 / 151 (47.68%)
         occurrences all number
    72
    Febrile neutropenia
         subjects affected / exposed
    8 / 151 (5.30%)
         occurrences all number
    8
    Neutropenia
         subjects affected / exposed
    34 / 151 (22.52%)
         occurrences all number
    34
    Leukopenia
         subjects affected / exposed
    11 / 151 (7.28%)
         occurrences all number
    11
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    37 / 151 (24.50%)
         occurrences all number
    37
    Pyrexia
         subjects affected / exposed
    23 / 151 (15.23%)
         occurrences all number
    23
    Asthenia
         subjects affected / exposed
    17 / 151 (11.26%)
         occurrences all number
    17
    Mucosal inflammation
         subjects affected / exposed
    7 / 151 (4.64%)
         occurrences all number
    7
    Oedema peripheral
         subjects affected / exposed
    12 / 151 (7.95%)
         occurrences all number
    12
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    12 / 151 (7.95%)
         occurrences all number
    12
    Nausea
         subjects affected / exposed
    33 / 151 (21.85%)
         occurrences all number
    33
    Diarrhoea
         subjects affected / exposed
    30 / 151 (19.87%)
         occurrences all number
    30
    Vomiting
         subjects affected / exposed
    17 / 151 (11.26%)
         occurrences all number
    17
    Constipation
         subjects affected / exposed
    19 / 151 (12.58%)
         occurrences all number
    19
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    17 / 151 (11.26%)
         occurrences all number
    17
    Cough
         subjects affected / exposed
    18 / 151 (11.92%)
         occurrences all number
    18
    Epistaxis
         subjects affected / exposed
    16 / 151 (10.60%)
         occurrences all number
    16
    Oropharyngeal pain
         subjects affected / exposed
    7 / 151 (4.64%)
         occurrences all number
    7
    Nasal congestion
         subjects affected / exposed
    9 / 151 (5.96%)
         occurrences all number
    9
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    9 / 151 (5.96%)
         occurrences all number
    9
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    25 / 151 (16.56%)
         occurrences all number
    25
    Bone pain
         subjects affected / exposed
    23 / 151 (15.23%)
         occurrences all number
    23
    Pain in extremity
         subjects affected / exposed
    15 / 151 (9.93%)
         occurrences all number
    15
    Arthralgia
         subjects affected / exposed
    10 / 151 (6.62%)
         occurrences all number
    10
    Musculoskeletal chest pain
         subjects affected / exposed
    10 / 151 (6.62%)
         occurrences all number
    10
    Muscle spasms
         subjects affected / exposed
    9 / 151 (5.96%)
         occurrences all number
    9
    Musculoskeletal pain
         subjects affected / exposed
    9 / 151 (5.96%)
         occurrences all number
    9
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    10 / 151 (6.62%)
         occurrences all number
    10
    Respiratory tract infection
         subjects affected / exposed
    8 / 151 (5.30%)
         occurrences all number
    8
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 151 (9.27%)
         occurrences all number
    14
    Nasopharyngitis
         subjects affected / exposed
    7 / 151 (4.64%)
         occurrences all number
    7
    Sinusitis
         subjects affected / exposed
    7 / 151 (4.64%)
         occurrences all number
    7
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    26 / 151 (17.22%)
         occurrences all number
    26
    Hypokalaemia
         subjects affected / exposed
    20 / 151 (13.25%)
         occurrences all number
    20
    Hypercalcaemia
         subjects affected / exposed
    13 / 151 (8.61%)
         occurrences all number
    13
    Hyperuricaemia
         subjects affected / exposed
    12 / 151 (7.95%)
         occurrences all number
    12
    Hyponatraemia
         subjects affected / exposed
    8 / 151 (5.30%)
         occurrences all number
    8
    Hypomagnesaemia
         subjects affected / exposed
    7 / 151 (4.64%)
         occurrences all number
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Mar 2015
    In order to make the study available to a larger group of appropriate patients, the platelet count required for study entry was reduced to 50 × 10^9/L for all patients, regardless of the % plasma cells in the bone marrow. This change is not expected to result in additional safety concerns, as the dose modification criteria relating to hematologic abnormalities (including thrombocytopenia) have not been changed. Additional substantive changes are as follows: • The upper limit on filanesib dose based on body surface area (BSA) was removed, as it was not supported by safety or pharmacokinetics data to date. • Acceptable methods of skeletal imaging were expanded to include whole-body low-dose computed tomography. • Acceptable methods of plasmacytoma measurement were expanded to include physical examination. • Recommendations regarding dose and duration of prophylactic filgrastim administration were added. • Requirement for a 1-week duration between assessments to confirm PD was removed, as it is not required per IMWG criteria. • Guidance regarding stability of drug product following reconstitution and dilution was updated.

    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.
    None reported
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