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    Clinical Trial Results:
    A Phase 2, Double-Blind, Placebo-Controlled Study of IPI-504 and Docetaxel in Previously Treated patients with Stage IIIB or IV Non-Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2011-000201-44
    Trial protocol
    		 HU  
    Global end of trial date
    31 Jul 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    09 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IPI-504-14
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number: 68,300
    Sponsors
    Sponsor organisation name
    Infinity Pharmaceuticals, Inc.
    Sponsor organisation address
    780 Memorial Drive, Cambridge, MA, United States, 02139
    Public contact
    IPI-504-14 Trial Information, Infinity Pharmaceuticals, Inc, +1 617453 1000,
    Scientific contact
    David A. Roth, MD, Infinity Pharmaceuticals, Inc, +1 617453 1412,
    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
    23 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the overall survival (OS) of subjects with previously-treated non-small cell lung cancer (NSCLC) administered IPI-504 plus docetaxel to subjects treated with placebo plus docetaxel in all subjects and subjects with squamous cell carcinoma (determined by central histology review)
    Protection of trial subjects
    An external DMC was chartered to perform a safety review when approximately 20 patients completed 1 cycle and additional periodic or as needed safety reviews throughout the study. At the time of the review of the first 20 patients, the DMC may recommend lowering the starting dose of IPI-504/placebo for the remainder of the clinical study. The Sponsor will make all final decisions regarding any changes in study conduct. The DMC will be independent of the Sponsor or Sponsor designees. Members of the DMC have no involvement in the study outside of their role on the DMC and will not act as Investigators or Sub-investigators on Infinity-sponsored trials. The DMC consists of 3 members, including at least two medical oncologists. Additional experts may be consulted on an ad hoc basis as needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jun 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    Romania: 21
    Country: Number of subjects enrolled
    Korea, Republic of: 13
    Country: Number of subjects enrolled
    Russian Federation: 21
    Country: Number of subjects enrolled
    United States: 159
    Country: Number of subjects enrolled
    Taiwan: 1
    Worldwide total number of subjects
    226
    EEA total number of subjects
    32
    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)
    136
    From 65 to 84 years
    90
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 320 [1]
    Number of subjects completed
    		 226

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen failure: 94
    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: The number of screened patients (152) per country and per age group has been collected but has not been prespecified in the Statistical Analysis Plan. Therefore, the number of randomized patients (105) per country and per age group is indicated in the Trial information section.
    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IPI-504 plus docetaxel
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPI-504
    Investigational medicinal product code
    PR1
    Other name
    Carbamic acid 19-allylamino-13,20,22-trihydroxy-8,14-dimethoxy-4,10,12,16-tetramethyl-3-oxo-2-aza-bicyclo[16.3.1]docosa-1(21),4,6,10,18(22),19-hexaen-9-yl ester
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IPI-504 or placebo will be administered IV weekly (Days 1, 8, and 15) during each 21-day cycle. IPI-504 will be reconstituted by an unblinded pharmacist and administered in a 250 mL Sodium Chloride Injection Solution, USP/EP/JP/KP and infused IV over 30 minutes (±5 minutes).

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle) at a starting dose of 75 mg/m2 or 60 mg/m2 in South Korea and Taiwan up to 90 minutes (±15 minutes).

    Arm title
    		 Placebo plus docetaxel
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IPI-504 or placebo will be administered IV weekly (Days 1, 8, and 15) during each 21-day cycle. IPI-504 will be reconstituted by an unblinded pharmacist and administered in a 250 mL Sodium Chloride Injection Solution, USP/EP/JP/KP and infused IV over 30 minutes (±5 minutes).

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle) at a starting dose of 75 mg/m2 or 60 mg/m2 in South Korea and Taiwan up to 90 minutes (±15 minutes).

    Number of subjects in period 1
    		IPI-504 plus docetaxel Placebo plus docetaxel
    Started
    114
    112
    Completed
    5
    1
    Not completed
    109
    111
         Adverse event, serious fatal
    18
    12
         Physician decision
    7
    9
         Consent withdrawn by subject
    7
    3
         Adverse event, non-fatal
    16
    15
         Other
    11
    7
         Progressive disease
    49
    63
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 226 226
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 136 136
        From 65 to 75 years
    		 79 79
        75 years and over
    		 11 11
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 61.7 (32 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 68 68
        Male
    		 158 158
    Subject analysis sets

    Subject analysis set title
    IPI-504 and docetaxel
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all randomized patients with on-treatment data. The FAS is used for all efficacy analyses. The per-protocol set (PPS) includes all FAS patients who are not excluded due to a significant protocol violation, where a significant protocol violation is one that has the potential to affect analysis conclusions. Final determinations of significant protocol violations will be made at the final blind data review meeting in accordance with ICH E9. The safety set (SAF) includes all patients who received at least one dose of IPI-504 or placebo. The SAF is used for all safety analyses. It is intended that the primary analysis on the FAS will include all enrolled patients (combined, total study population) who receive at least one dose of study medication and have at least one post-baseline assessment. Patients who are misclassified at Screening as belonging to identified subpopulations will not be included in the FAS for subpopulation.

    Subject analysis set title
    Placebo and docetaxel
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all randomized patients with on-treatment data. The FAS is used for all efficacy analyses. The per-protocol set (PPS) includes all FAS patients who are not excluded due to a significant protocol violation, where a significant protocol violation is one that has the potential to affect analysis conclusions. Final determinations of significant protocol violations will be made at the final blind data review meeting in accordance with ICH E9. The safety set (SAF) includes all patients who received at least one dose of IPI-504 or placebo. The SAF is used for all safety analyses. It is intended that the primary analysis on the FAS will include all enrolled patients (combined, total study population) who receive at least one dose of study medication and have at least one post-baseline assessment. Patients who are misclassified at Screening as belonging to identified subpopulations will not be included in the FAS for subpopulation.

    Subject analysis sets values
    		 IPI-504 and docetaxel Placebo and docetaxel
    Number of subjects
    114
    112
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    68
    68
        From 65 to 75 years
    42
    37
        75 years and over
    4
    7
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    61 (32 to 82)
    62.3 (42 to 81)
    Gender categorical
    Units: Subjects
        Female
    36
    32
        Male
    78
    80

    End points

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    End points reporting groups
    Reporting group title
    IPI-504 plus docetaxel
    Reporting group description
    		 -

    Reporting group title
    Placebo plus docetaxel
    Reporting group description
    		 -

    Subject analysis set title
    IPI-504 and docetaxel
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all randomized patients with on-treatment data. The FAS is used for all efficacy analyses. The per-protocol set (PPS) includes all FAS patients who are not excluded due to a significant protocol violation, where a significant protocol violation is one that has the potential to affect analysis conclusions. Final determinations of significant protocol violations will be made at the final blind data review meeting in accordance with ICH E9. The safety set (SAF) includes all patients who received at least one dose of IPI-504 or placebo. The SAF is used for all safety analyses. It is intended that the primary analysis on the FAS will include all enrolled patients (combined, total study population) who receive at least one dose of study medication and have at least one post-baseline assessment. Patients who are misclassified at Screening as belonging to identified subpopulations will not be included in the FAS for subpopulation.

    Subject analysis set title
    Placebo and docetaxel
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all randomized patients with on-treatment data. The FAS is used for all efficacy analyses. The per-protocol set (PPS) includes all FAS patients who are not excluded due to a significant protocol violation, where a significant protocol violation is one that has the potential to affect analysis conclusions. Final determinations of significant protocol violations will be made at the final blind data review meeting in accordance with ICH E9. The safety set (SAF) includes all patients who received at least one dose of IPI-504 or placebo. The SAF is used for all safety analyses. It is intended that the primary analysis on the FAS will include all enrolled patients (combined, total study population) who receive at least one dose of study medication and have at least one post-baseline assessment. Patients who are misclassified at Screening as belonging to identified subpopulations will not be included in the FAS for subpopulation.

    Primary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall Survival (OS), defined as time from randomization to death due to any cause
    End point type
    Primary
    End point timeframe
    Q4 2013
    End point values
    		 IPI-504 plus docetaxel Placebo plus docetaxel IPI-504 and docetaxel Placebo and docetaxel
    Number of subjects analysed
    114
    112
    114
    112
    Units: months
        number (confidence interval 95%)
    7.9 (5.65 to 10.64)
    6.2 (5.36 to 7.95)
    7.9 (5.65 to 10.64)
    6.2 (5.36 to 7.95)
    Statistical analysis title
    		 Kaplan Meyer estimate
    Comparison groups
    IPI-504 and docetaxel v Placebo and docetaxel
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.208
    Method
    		 Logrank
    Confidence interval

    Secondary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR)
    End point description
    Overall Response Rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Criteria in Solid Tumors (RECIST 1.1)
    End point type
    Secondary
    End point timeframe
    Q4 2013
    End point values
    		 IPI-504 plus docetaxel Placebo plus docetaxel IPI-504 and docetaxel Placebo and docetaxel
    Number of subjects analysed
    114
    112
    226
    226
    Units: N/A
        number (confidence interval 95%)
    14 (6.9 to 19.8)
    19 (10.5 to 25.2)
    14 (6.9 to 19.8)
    19 (10.5 to 25.2)
    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 (PFS), defined as time from randomization to disease progression or death whichever occurs first
    End point type
    Secondary
    End point timeframe
    Q4 2013
    End point values
    		 IPI-504 plus docetaxel Placebo plus docetaxel IPI-504 and docetaxel Placebo and docetaxel
    Number of subjects analysed
    114
    112
    226
    226
    Units: N/A
        number (confidence interval 95%)
    3.71 (2.6 to 4.4)
    2.76 (1.8 to 3.5)
    3.71 (2.6 to 4.4)
    2.76 (1.8 to 3.5)
    No statistical analyses for this end point

    Secondary: Time to Progression (TTP)

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    End point title
    		 Time to Progression (TTP)
    End point description
    Time to Progression (TTP), defined as time from randomization to disease progression (per RECIST 1.1)
    End point type
    Secondary
    End point timeframe
    Q4 2013
    End point values
    		 IPI-504 plus docetaxel Placebo plus docetaxel IPI-504 and docetaxel Placebo and docetaxel
    Number of subjects analysed
    114
    112
    226
    226
    Units: N/A
        number (confidence interval 95%)
    4.37 (3.7 to 5.6)
    2.99 (2.6 to 4.1)
    4.37 (3.7 to 5.6)
    2.99 (2.6 to 4.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs will be recorded from the time of informed consent until 30 days after the last dose of study treatment.
    Adverse event reporting additional description
    Patients will be instructed to report all AEs and will be asked a general health status question at each study visit. All AEs, whether volunteered or elicited, will be recorded on the eCRF. An AE should be followed until it is either resolved, has returned to baseline, or is determined to be a stable or chronic condition.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    IPI-504 and Docetaxel
    Reporting group description
    		 -

    Reporting group title
    Placebo and Docetaxel
    Reporting group description
    		 -

    Serious adverse events
    		 IPI-504 and Docetaxel Placebo and Docetaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    98 / 113 (86.73%)
    92 / 109 (84.40%)
         number of deaths (all causes)
    25
    28
         number of deaths resulting from adverse events
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 113 (1.77%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    4 / 113 (3.54%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 113 (0.00%)
    3 / 109 (2.75%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Acute myocardial infarction
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    8 / 113 (7.08%)
    17 / 109 (15.60%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 7
    0 / 17
    Multi-organ failure
         subjects affected / exposed
    4 / 113 (3.54%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Pyrexia
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    9 / 113 (7.96%)
    4 / 109 (3.67%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    2 / 113 (1.77%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 113 (0.88%)
    3 / 109 (2.75%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 113 (4.42%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    5 / 113 (4.42%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    4 / 113 (3.54%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    5 / 113 (4.42%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    4 / 113 (3.54%)
    3 / 109 (2.75%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 113 (2.65%)
    4 / 109 (3.67%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Pulmonary embolism
         subjects affected / exposed
    2 / 113 (1.77%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 113 (0.88%)
    3 / 109 (2.75%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 113 (0.88%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung infection pseudomonal
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    13 / 113 (11.50%)
    19 / 109 (17.43%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Septic shock
         subjects affected / exposed
    3 / 113 (2.65%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 113 (1.77%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    4 / 113 (3.54%)
    4 / 109 (3.67%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 IPI-504 and Docetaxel Placebo and Docetaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    111 / 113 (98.23%)
    105 / 109 (96.33%)
    Investigations
    Urine colour abnormal
         subjects affected / exposed
    22 / 113 (19.47%)
    0 / 109 (0.00%)
         occurrences all number
    111
    105
    Alanine aminotransferase increased
         subjects affected / exposed
    15 / 113 (13.27%)
    6 / 109 (5.50%)
         occurrences all number
    111
    105
    White blood cell count decreased
         subjects affected / exposed
    10 / 113 (8.85%)
    17 / 109 (15.60%)
         occurrences all number
    111
    105
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    7 / 113 (6.19%)
    0 / 109 (0.00%)
         occurrences all number
    111
    105
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    12 / 113 (10.62%)
    6 / 109 (5.50%)
         occurrences all number
    111
    105
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    19 / 113 (16.81%)
    9 / 109 (8.26%)
         occurrences all number
    111
    105
    Disease progression
         subjects affected / exposed
    8 / 113 (7.08%)
    17 / 109 (15.60%)
         occurrences all number
    111
    105
    Infusion site pain
         subjects affected / exposed
    7 / 113 (6.19%)
    1 / 109 (0.92%)
         occurrences all number
    111
    105
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    31 / 113 (27.43%)
    22 / 109 (20.18%)
         occurrences all number
    111
    105
    Leukopenia
         subjects affected / exposed
    20 / 113 (17.70%)
    11 / 109 (10.09%)
         occurrences all number
    111
    105
    Febrile neutropenia
         subjects affected / exposed
    14 / 113 (12.39%)
    8 / 109 (7.34%)
         occurrences all number
    111
    105
    Blood alkaline phosphatase increased
         subjects affected / exposed
    15 / 113 (13.27%)
    6 / 109 (5.50%)
         occurrences all number
    111
    105
    Aspartate aminotransferase increased
         subjects affected / exposed
    13 / 113 (11.50%)
    5 / 109 (4.59%)
         occurrences all number
    111
    105
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    62 / 113 (54.87%)
    34 / 109 (31.19%)
         occurrences all number
    111
    105
    Nausea
         subjects affected / exposed
    49 / 113 (43.36%)
    29 / 109 (26.61%)
         occurrences all number
    111
    105
    Vomiting
         subjects affected / exposed
    28 / 113 (24.78%)
    10 / 109 (9.17%)
         occurrences all number
    111
    105
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    22 / 113 (19.47%)
    29 / 109 (26.61%)
         occurrences all number
    111
    105
    Productive cough
         subjects affected / exposed
    9 / 113 (7.96%)
    3 / 109 (2.75%)
         occurrences all number
    111
    105
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    30 / 113 (26.55%)
    22 / 109 (20.18%)
         occurrences all number
    111
    105
    Rash
         subjects affected / exposed
    18 / 113 (15.93%)
    6 / 109 (5.50%)
         occurrences all number
    111
    105
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    9 / 113 (7.96%)
    1 / 109 (0.92%)
         occurrences all number
    111
    105
    Muscular weakness
         subjects affected / exposed
    7 / 113 (6.19%)
    13 / 109 (11.93%)
         occurrences all number
    111
    105

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Mar 2011
    Protocol Amendment 1
    16 Nov 2011
    Protocol Amendment 2
    05 Dec 2011
    IMPD Amendment
    29 Feb 2012
    Protocol Amendment 3
    12 Mar 2012
    IB Edition 15
    31 May 2012
    Protocol Amendment 5

    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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