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    Clinical Trial Results:
    Randomized, Open-Label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-Agent and Two Different Regimens of the Poly ADP Ribose Polymerase-1 Inhibitor SAR240550 (BSI-201) in Combination with Weekly Paclitaxel, as Neoadjuvant Therapy in Patients with Stage II-IIIA Triple Negative Breast Cancer (TNBC)

    Summary
    EudraCT number
    2010-018960-17
    Trial protocol
    ES   FR   DE  
    Global end of trial date
    28 Feb 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Mar 2018
    First version publication date
    14 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TCD11419
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01204125
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    STUDY NAME: SOLTI NeoPARP
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    21 Apr 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess the pathologic complete response (pCR) rate in the breast of subjects with operable Stage II to IIIA triple-negative breast cancer (TNBC) treated with paclitaxel weekly + SAR240550 (iniparib) twice weekly (paclitaxel + tw-iniparib arm), with paclitaxel weekly + iniparib weekly (paclitaxel + w-iniparib arm), and with paclitaxel weekly as a single-agent reference treatment (paclitaxel-only arm).
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Sep 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 95
    Country: Number of subjects enrolled
    France: 39
    Country: Number of subjects enrolled
    Germany: 7
    Worldwide total number of subjects
    141
    EEA total number of subjects
    141
    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)
    119
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 24 centres in 3 European countries between 20 September 2010 and 28 February 2017.

    Pre-assignment
    Screening details
    A total of 141 subjects were enrolled and randomised in a 1:1:1 ratio to paclitaxel-only arm, paclitaxel + w (once per week)-iniparib arm, and paclitaxel + tw (twice per week)-iniparib arm according to the following stratification factors: axillary nodal involvement (yes or no) and tumor size (=<5 cm or >5 cm).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Paclitaxel
    Arm description
    Paclitaxel 80 mg/m^2 intravenous (IV) infusion on Day 1 of 12 cycles of 7 days each, until disease progression (DP), unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).
    Arm type
    Active comparator

    Investigational medicinal product name
    Non IMP: Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was administered on Day 1 of 12 cycles of 7 days each (maximum duration up to 15 weeks).

    Arm title
    Paclitaxel + Iniparib Once Weekly
    Arm description
    Paclitaxel 80 mg/m^2 IV infusion on Day 1 of 12 cycles of 7 days each, in combination with iniparib 11.2 mg/kg IV once weekly (Day 1) for a maximum of 12 administrations, until DP, unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).
    Arm type
    Experimental

    Investigational medicinal product name
    Non IMP: Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was administered on Day 1 of 12 cycles of 7 days each, up to 12 IV infusions (maximum duration up to 15 weeks).

    Investigational medicinal product name
    Iniparib
    Investigational medicinal product code
    SAR2405550
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Iniparib infusion started within 1 hour after the end of paclitaxel administration on Day 1 of each week in the paclitaxel + w-iniparib arm over a total period up to 15 weeks.

    Arm title
    Paclitaxel + Iniparib Twice Weekly
    Arm description
    Paclitaxel 80 mg/m^2 IV infusion on Day 1 of 12 cycles of 7 days each, in combination with iniparib 5.6 mg/kg IV twice weekly (Day 1 and Day 4) for a maximum of 24 administrations, until DP, unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).
    Arm type
    Experimental

    Investigational medicinal product name
    Non IMP: Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was administered on Day 1 of 12 cycles of 7 days each, up to 12 IV infusions (maximum duration up to 15 weeks).

    Investigational medicinal product name
    Iniparib
    Investigational medicinal product code
    SAR2405550
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Iniparib infusion started within 1 hour after the end of paclitaxel administration on Day 1 and Day 4 of each week in the paclitaxel + tw- iniparib arm over a total period up to 15 weeks.

    Number of subjects in period 1
    Paclitaxel Paclitaxel + Iniparib Once Weekly Paclitaxel + Iniparib Twice Weekly
    Started
    47
    46
    48
    Completed
    39
    38
    39
    Not completed
    8
    8
    9
         Disease Progression
    2
    4
    7
         Randomized not treated
    1
    -
    -
         Other than specified above
    4
    2
    1
         Adverse Event
    1
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Paclitaxel
    Reporting group description
    Paclitaxel 80 mg/m^2 intravenous (IV) infusion on Day 1 of 12 cycles of 7 days each, until disease progression (DP), unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).

    Reporting group title
    Paclitaxel + Iniparib Once Weekly
    Reporting group description
    Paclitaxel 80 mg/m^2 IV infusion on Day 1 of 12 cycles of 7 days each, in combination with iniparib 11.2 mg/kg IV once weekly (Day 1) for a maximum of 12 administrations, until DP, unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).

    Reporting group title
    Paclitaxel + Iniparib Twice Weekly
    Reporting group description
    Paclitaxel 80 mg/m^2 IV infusion on Day 1 of 12 cycles of 7 days each, in combination with iniparib 5.6 mg/kg IV twice weekly (Day 1 and Day 4) for a maximum of 24 administrations, until DP, unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).

    Reporting group values
    Paclitaxel Paclitaxel + Iniparib Once Weekly Paclitaxel + Iniparib Twice Weekly Total
    Number of subjects
    47 46 48 141
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.9 ± 10.3 50.9 ± 14.3 50.1 ± 12.2 -
    Gender categorical
    Units: Subjects
        Female
    47 46 48 141
        Male
    0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Paclitaxel
    Reporting group description
    Paclitaxel 80 mg/m^2 intravenous (IV) infusion on Day 1 of 12 cycles of 7 days each, until disease progression (DP), unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).

    Reporting group title
    Paclitaxel + Iniparib Once Weekly
    Reporting group description
    Paclitaxel 80 mg/m^2 IV infusion on Day 1 of 12 cycles of 7 days each, in combination with iniparib 11.2 mg/kg IV once weekly (Day 1) for a maximum of 12 administrations, until DP, unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).

    Reporting group title
    Paclitaxel + Iniparib Twice Weekly
    Reporting group description
    Paclitaxel 80 mg/m^2 IV infusion on Day 1 of 12 cycles of 7 days each, in combination with iniparib 5.6 mg/kg IV twice weekly (Day 1 and Day 4) for a maximum of 24 administrations, until DP, unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).

    Primary: Percentage of Subjects With Pathological Complete Response (PCR) Rate in Breast

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    End point title
    Percentage of Subjects With Pathological Complete Response (PCR) Rate in Breast [1]
    End point description
    PCR rate in breast was defined as the complete absence of invasive carcinoma on histological examination of the breast at the time of definitive surgery and confirmed by a centralized, blinded review. Analysis was performed on Intent-to-treat (ITT) population that included all randomized subjects who had given their informed consent and for whom there was confirmation of successful allocation of a randomization number through the interactive voice response system (IVRS).
    End point type
    Primary
    End point timeframe
    Baseline up to the 4 weeks after last dose of study drug on Week 15 (up to Week 19)
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    Paclitaxel Paclitaxel + Iniparib Once Weekly Paclitaxel + Iniparib Twice Weekly
    Number of subjects analysed
    47
    46
    48
    Units: Percentage of subjects
        number (confidence interval 95%)
    21.3 (10.7 to 35.7)
    21.7 (10.9 to 36.4)
    18.8 (8.9 to 32.6)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With PCR Rate in Breast and Axilla

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    End point title
    Percentage of Subjects With PCR Rate in Breast and Axilla
    End point description
    PCR rate in the breast and axilla was defined as the complete absence of invasive carcinoma on histological examination at the time of definitive surgery as assessed and confirmed by centralized, blinded review. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline up to the 4 weeks after last dose of study drug on Week 15 (up to Week 19)
    End point values
    Paclitaxel Paclitaxel + Iniparib Once Weekly Paclitaxel + Iniparib Twice Weekly
    Number of subjects analysed
    47
    46
    48
    Units: Percentage of subjects
        number (confidence interval 95%)
    21.3 (10.7 to 35.7)
    17.4 (7.8 to 31.4)
    18.8 (8.9 to 32.6)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Best Overall Response

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    End point title
    Percentage of Subjects With Best Overall Response
    End point description
    Best overall response was defined as best response (in order of confirmed complete response [CR], confirmed partial response [PR], stable disease [SD] & progressive disease [PD]) among all overall response based on RECIST 1.1. CR was defined as disappearance of all target/non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (target/non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference to baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference to smallest sum diameter since the treatment started and Progressive Disease (PD): At least a 20% increase in the sum diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline up to tumor progression or death due to any cause or study cut-off date, whichever occurs first (maximum duration: 1.5 years)
    End point values
    Paclitaxel Paclitaxel + Iniparib Once Weekly Paclitaxel + Iniparib Twice Weekly
    Number of subjects analysed
    47
    46
    48
    Units: Percentage of subjects
    number (not applicable)
        Complete response
    6.4
    0
    4.2
        Partial response
    53.2
    60.9
    58.3
        Stable disease
    31.9
    32.6
    25.0
        Progressive disease
    4.3
    4.3
    12.5
        Not evaluable
    4.3
    2.2
    0
        Overall response rate (CR+PR)
    59.6
    60.9
    62.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Breast Conservation

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    End point title
    Percentage of Subjects With Breast Conservation
    End point description
    Breast conservation rate (BCR) was defined as the proportion of subjects with limited breast surgery after the study treatment. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline up to tumor progression or death due to any cause or study cut-off date, whichever occurs first (maximum duration: 1.5 years)
    End point values
    Paclitaxel Paclitaxel + Iniparib Once Weekly Paclitaxel + Iniparib Twice Weekly
    Number of subjects analysed
    47
    46
    48
    Units: Percentage of subjects
        number (confidence interval 95%)
    53.2 (38.1 to 67.9)
    54.3 (39.0 to 69.1)
    50.0 (35.2 to 64.8)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Treatment Emergent Adverse Event (TEAE)

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    End point title
    Percentage of Subjects With Treatment Emergent Adverse Event (TEAE)
    End point description
    Any untoward medical occurrence in a subject who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period. On-treatment period was defined as the time from the IMP until 30 days after the last administration of IMP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-subject hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included subjects with both serious and non-serious AEs. Analysis was performed on safety population which was defined as subset of randomized subjects who received at least 1 (even incomplete) part of the study treatments.
    End point type
    Secondary
    End point timeframe
    Baseline up to 30 days after last dose of study drug (maximum duration: 1.5 years)
    End point values
    Paclitaxel Paclitaxel + Iniparib Once Weekly Paclitaxel + Iniparib Twice Weekly
    Number of subjects analysed
    47
    46
    48
    Units: Percentage of subjects
    number (not applicable)
        Any TEAE
    93.5
    97.8
    97.9
        Any treatment-emergent SAE
    4.3
    4.3
    4.2
        Any TEAE leading to permanent discontinuation
    2.2
    4.3
    2.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Disease free survival (DFS)

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    End point title
    Percentage of Subjects With Disease free survival (DFS)
    End point description
    DFS was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. Data for this end point was not analysed based on sponsor’s discretion.
    End point type
    Secondary
    End point timeframe
    Baseline up to tumor progression or death due to any cause or end of follow up period, whichever occurs first (maximum duration: 6.6 years)
    End point values
    Paclitaxel Paclitaxel + Iniparib Once Weekly Paclitaxel + Iniparib Twice Weekly
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [2] - Due to change in planned analysis, based on sponsor’s discretion, data for this was not analyzed.
    [3] - Due to change in planned analysis, based on sponsor’s discretion, data for this was not analyzed.
    [4] - Due to change in planned analysis, based on sponsor’s discretion, data for this was not analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Overall Survival

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    End point title
    Percentage of Subjects With Overall Survival
    End point description
    Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. Data for this end point was not analysed based on sponsor’s discretion.
    End point type
    Secondary
    End point timeframe
    Baseline up to tumor progression or death due to any cause or end of follow up period, whichever occurs first (maximum duration: 6.6 years)
    End point values
    Paclitaxel Paclitaxel + Iniparib Once Weekly Paclitaxel + Iniparib Twice Weekly
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [5] - Due to change in planned analysis, based on sponsor’s discretion, data for this was not analyzed.
    [6] - Due to change in planned analysis, based on sponsor’s discretion, data for this was not analyzed.
    [7] - Due to change in planned analysis, based on sponsor’s discretion, data for this was not analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum duration: 6.6 years) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs are TEAEs that is AEs that developed/worsened during the ‘on treatment period’ (from first study treatment administration until 30 days after the last administration of study treatment). Analysis was performed on safety population.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Paclitaxel
    Reporting group description
    Paclitaxel 80 mg/m^2 IV infusion on Day 1 of 12 cycles of 7 days each, until DP, unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).

    Reporting group title
    Paclitaxel + Iniparib Once Weekly
    Reporting group description
    Paclitaxel 80 mg/m^2 IV infusion on Day 1 of 12 cycles of 7 days each, in combination with iniparib 11.2 mg/kg IV once weekly (Day 1) for a maximum of 12 administrations, until DP, unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).

    Reporting group title
    Paclitaxel + Iniparib Twice Weekly
    Reporting group description
    Paclitaxel 80 mg/m^2 IV infusion on Day 1 of 12 cycles of 7 days each, in combination with iniparib 5.6 mg/kg IV twice weekly (Day 1 and Day 4) for a maximum of 24 administrations, until DP, unacceptable toxicity or subject’s refusal (maximum duration up to 15 weeks).

    Serious adverse events
    Paclitaxel Paclitaxel + Iniparib Once Weekly Paclitaxel + Iniparib Twice Weekly
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 46 (6.52%)
    2 / 46 (4.35%)
    2 / 48 (4.17%)
         number of deaths (all causes)
    3
    15
    12
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Radius Fracture
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Embolism
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Atypical Pneumonia
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected Skin Ulcer
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Paclitaxel Paclitaxel + Iniparib Once Weekly Paclitaxel + Iniparib Twice Weekly
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 46 (93.48%)
    45 / 46 (97.83%)
    47 / 48 (97.92%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    2 / 48 (4.17%)
         occurrences all number
    0
    1
    2
    Haematoma
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    Hot Flush
         subjects affected / exposed
    5 / 46 (10.87%)
    3 / 46 (6.52%)
    5 / 48 (10.42%)
         occurrences all number
    5
    3
    5
    Hypertension
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    2 / 48 (4.17%)
         occurrences all number
    0
    1
    2
    Lymphocele
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    Lymphoedema
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Phlebitis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Vein Disorder
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    2
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    2
    1
    Immune system disorders
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 46 (2.17%)
    2 / 46 (4.35%)
    4 / 48 (8.33%)
         occurrences all number
    1
    2
    4
    Hypersensitivity
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    2
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    26 / 46 (56.52%)
    21 / 46 (45.65%)
    24 / 48 (50.00%)
         occurrences all number
    38
    30
    41
    Axillary Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    3 / 46 (6.52%)
    0 / 48 (0.00%)
         occurrences all number
    0
    3
    0
    Catheter Site Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Catheter Site Related Reaction
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Chest Discomfort
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Chest Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Chills
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Face Oedema
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    1
    0
    1
    Fatigue
         subjects affected / exposed
    8 / 46 (17.39%)
    6 / 46 (13.04%)
    6 / 48 (12.50%)
         occurrences all number
    11
    8
    8
    Influenza Like Illness
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    2
    Infusion Site Extravasation
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Infusion Site Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    2 / 48 (4.17%)
         occurrences all number
    0
    1
    2
    Injection Site Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Mucosal Dryness
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Oedema
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Oedema Peripheral
         subjects affected / exposed
    4 / 46 (8.70%)
    1 / 46 (2.17%)
    5 / 48 (10.42%)
         occurrences all number
    4
    1
    6
    Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Puncture Site Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    2 / 46 (4.35%)
    4 / 46 (8.70%)
    0 / 48 (0.00%)
         occurrences all number
    2
    5
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Anhedonia
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Anxiety
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 46 (4.35%)
    4 / 48 (8.33%)
         occurrences all number
    0
    2
    4
    Depression
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 46 (2.17%)
    5 / 46 (10.87%)
    3 / 48 (6.25%)
         occurrences all number
    1
    6
    3
    Reproductive system and breast disorders
    Adnexa Uteri Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Amenorrhoea
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Breast Discomfort
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    Breast Oedema
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Breast Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 46 (4.35%)
    2 / 48 (4.17%)
         occurrences all number
    0
    3
    2
    Dysmenorrhoea
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    Genital Tract Inflammation
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Menstruation Irregular
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    3 / 48 (6.25%)
         occurrences all number
    1
    1
    3
    Nipple Exudate Bloody
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Pelvic Pain
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    1
    Vaginal Haemorrhage
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Arthropod Sting
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Infusion Related Reaction
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    3 / 48 (6.25%)
         occurrences all number
    0
    0
    12
    Ligament Sprain
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Rib Fracture
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Seroma
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    1
    Blood Calcium Decreased
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Blood Glucose Increased
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    Blood Potassium Decreased
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Haemoglobin Decreased
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    1
    Weight Increased
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    1
    0
    2
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    2
    1
    0
    Tachycardia
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    2
    0
    2
    Cough
         subjects affected / exposed
    3 / 46 (6.52%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    3
    0
    1
    Dysphonia
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    Epistaxis
         subjects affected / exposed
    6 / 46 (13.04%)
    3 / 46 (6.52%)
    4 / 48 (8.33%)
         occurrences all number
    7
    5
    4
    Nasal Dryness
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal Inflammation
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    3 / 48 (6.25%)
         occurrences all number
    2
    1
    4
    Leukopenia
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphopenia
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    2 / 48 (4.17%)
         occurrences all number
    0
    1
    2
    Neutropenia
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 46 (6.52%)
    5 / 48 (10.42%)
         occurrences all number
    4
    4
    5
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Aphonia
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 46 (2.17%)
    4 / 46 (8.70%)
    3 / 48 (6.25%)
         occurrences all number
    1
    4
    3
    Dysgeusia
         subjects affected / exposed
    5 / 46 (10.87%)
    4 / 46 (8.70%)
    6 / 48 (12.50%)
         occurrences all number
    7
    4
    11
    Headache
         subjects affected / exposed
    6 / 46 (13.04%)
    8 / 46 (17.39%)
    10 / 48 (20.83%)
         occurrences all number
    7
    9
    10
    Hypoaesthesia
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    2
    Migraine
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    2
    1
    Neurotoxicity
         subjects affected / exposed
    4 / 46 (8.70%)
    4 / 46 (8.70%)
    2 / 48 (4.17%)
         occurrences all number
    5
    4
    3
    Paraesthesia
         subjects affected / exposed
    8 / 46 (17.39%)
    5 / 46 (10.87%)
    4 / 48 (8.33%)
         occurrences all number
    8
    7
    4
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    13 / 46 (28.26%)
    10 / 46 (21.74%)
    14 / 48 (29.17%)
         occurrences all number
    14
    12
    17
    Presyncope
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Dry Eye
         subjects affected / exposed
    3 / 46 (6.52%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    3
    1
    0
    Eye Irritation
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    Eye Pruritus
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid Oedema
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Lacrimation Increased
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    1
    0
    1
    Vision Blurred
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Visual Acuity Reduced
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Ear Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    External Ear Inflammation
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoacusis
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Vertigo
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    5 / 48 (10.42%)
         occurrences all number
    1
    0
    6
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    1
    Abdominal Distension
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal Pain
         subjects affected / exposed
    4 / 46 (8.70%)
    4 / 46 (8.70%)
    2 / 48 (4.17%)
         occurrences all number
    4
    6
    2
    Abdominal Pain Upper
         subjects affected / exposed
    3 / 46 (6.52%)
    2 / 46 (4.35%)
    1 / 48 (2.08%)
         occurrences all number
    3
    2
    1
    Anal Fissure
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    5 / 46 (10.87%)
    7 / 46 (15.22%)
    5 / 48 (10.42%)
         occurrences all number
    6
    8
    7
    Diarrhoea
         subjects affected / exposed
    7 / 46 (15.22%)
    18 / 46 (39.13%)
    14 / 48 (29.17%)
         occurrences all number
    7
    23
    23
    Dry Mouth
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    2 / 48 (4.17%)
         occurrences all number
    1
    1
    2
    Dyspepsia
         subjects affected / exposed
    3 / 46 (6.52%)
    3 / 46 (6.52%)
    3 / 48 (6.25%)
         occurrences all number
    3
    4
    3
    Flatulence
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    1
    0
    1
    Gastritis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal Pain
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    1
    0
    2
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    1
    0
    1
    Nausea
         subjects affected / exposed
    4 / 46 (8.70%)
    7 / 46 (15.22%)
    11 / 48 (22.92%)
         occurrences all number
    5
    11
    15
    Obstruction Gastric
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Odynophagia
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal Haemorrhage
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    4 / 46 (8.70%)
    6 / 46 (13.04%)
    8 / 48 (16.67%)
         occurrences all number
    4
    7
    12
    Vomiting
         subjects affected / exposed
    3 / 46 (6.52%)
    2 / 46 (4.35%)
    5 / 48 (10.42%)
         occurrences all number
    4
    2
    9
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    1
    0
    1
    Renal Colic
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    3 / 48 (6.25%)
         occurrences all number
    1
    1
    3
    Alopecia
         subjects affected / exposed
    34 / 46 (73.91%)
    28 / 46 (60.87%)
    33 / 48 (68.75%)
         occurrences all number
    35
    28
    33
    Blister
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    1
    Dermatitis Acneiform
         subjects affected / exposed
    1 / 46 (2.17%)
    3 / 46 (6.52%)
    1 / 48 (2.08%)
         occurrences all number
    1
    4
    1
    Dermatitis Allergic
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    2
    Dry Skin
         subjects affected / exposed
    3 / 46 (6.52%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    3
    1
    1
    Eczema
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 46 (6.52%)
    5 / 48 (10.42%)
         occurrences all number
    2
    5
    6
    Generalised Erythema
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Nail Disorder
         subjects affected / exposed
    6 / 46 (13.04%)
    3 / 46 (6.52%)
    2 / 48 (4.17%)
         occurrences all number
    6
    3
    2
    Nail Ridging
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    Nail Toxicity
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    2
    1
    0
    Onychalgia
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Onycholysis
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 46 (4.35%)
    0 / 48 (0.00%)
         occurrences all number
    0
    2
    0
    Onychomadesis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Palmar-Plantar Erythrodysaesthesia Syndrome
         subjects affected / exposed
    0 / 46 (0.00%)
    3 / 46 (6.52%)
    1 / 48 (2.08%)
         occurrences all number
    0
    3
    1
    Pruritus
         subjects affected / exposed
    2 / 46 (4.35%)
    4 / 46 (8.70%)
    2 / 48 (4.17%)
         occurrences all number
    2
    7
    2
    Rash
         subjects affected / exposed
    7 / 46 (15.22%)
    3 / 46 (6.52%)
    6 / 48 (12.50%)
         occurrences all number
    10
    3
    7
    Rash Erythematous
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Rash Maculo-Papular
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    1
    Rash Pruritic
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Scab
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Skin Fissures
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Skin Hyperpigmentation
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Skin Lesion
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    1
    0
    1
    Skin Ulcer
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Solar Lentigo
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Swelling Face
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Urticaria
         subjects affected / exposed
    2 / 46 (4.35%)
    2 / 46 (4.35%)
    0 / 48 (0.00%)
         occurrences all number
    3
    2
    0
    Xeroderma
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 46 (13.04%)
    5 / 46 (10.87%)
    1 / 48 (2.08%)
         occurrences all number
    6
    5
    1
    Back Pain
         subjects affected / exposed
    1 / 46 (2.17%)
    3 / 46 (6.52%)
    1 / 48 (2.08%)
         occurrences all number
    1
    4
    1
    Bone Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    3 / 48 (6.25%)
         occurrences all number
    0
    1
    3
    Muscle Contracture
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle Spasms
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 46 (4.35%)
    0 / 48 (0.00%)
         occurrences all number
    0
    2
    0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    1
    0
    3
    Myalgia
         subjects affected / exposed
    6 / 46 (13.04%)
    5 / 46 (10.87%)
    3 / 48 (6.25%)
         occurrences all number
    7
    5
    4
    Neck Pain
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Pain In Extremity
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    1
    Pain In Jaw
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 46 (2.17%)
    2 / 46 (4.35%)
    4 / 48 (8.33%)
         occurrences all number
    1
    2
    6
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 46 (4.35%)
    0 / 48 (0.00%)
         occurrences all number
    0
    2
    0
    Conjunctivitis
         subjects affected / exposed
    3 / 46 (6.52%)
    2 / 46 (4.35%)
    5 / 48 (10.42%)
         occurrences all number
    3
    2
    6
    Cystitis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Erysipelas
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes Virus Infection
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes Zoster
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Infected Bite
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    6 / 46 (13.04%)
    7 / 46 (15.22%)
    5 / 48 (10.42%)
         occurrences all number
    6
    8
    5
    Neutropenic Infection
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    Skin Infection
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences all number
    2
    1
    0
    Urinary Tract Infection
         subjects affected / exposed
    2 / 46 (4.35%)
    2 / 46 (4.35%)
    2 / 48 (4.17%)
         occurrences all number
    3
    2
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Aug 2010
    Following amendments were made: 1-The follow-up after adjuvant breast cancer treatment was increased to 5 years. The schedule and frequency of tumor assessments were changed accordingly. After definitive surgery, subject tumor status and clinical laboratory tests are to be assessed every 3 months during the first 3 years and then every 6 months until the study cut-off date at 5 years from the date of surgery. 2-A safety assessment in the first 6 subjects receiving treatment in each experimental arm was added. Dose-limiting toxicity (DLT) definitions were provided. 3-The dose-modification section was amended to provide more detail.
    17 Dec 2012
    Following amendments were made: 1-Change to the subject follow up: Subjects were to be followed by the site accordingly to local standard of care (accordingly American Association of Medical Oncology physical examinations should be performed every 3 to 6 months for the first 3 years, every 6 to 12 months for years 4 and 5, and annually thereafter). The maximum follow up for each individual subject was until death or 5 years after definitive surgery date, whatever happened first. 2-Changes referred to the mechanism of action of SAR240550 (iniparib, BSI-201): Mechanism of action was updated as: Iniparib is a benzamide (4-iodo-3-nitrobenzamide) which is structurally related to nicotinamide. Benzamides have been shown to inhibit PARP1 activity. Iniparib binds to PARP1 in the NAD binding pocket as observed by X-ray crystallography. Iniparib inhibits PARP enzyme activity at high micromolar concentrations. However, recent pre-clinical and clinical data have indicated that iniparib does not possess characteristics typical of the PARP inhibitor class. The following observations regarding the cellular effects of iniparib have been made: 1. Iniparib induces gamma- H2AX (a marker of DNA damage) in tumor cell lines; 2. It induces cell cycle arrest in the G2/M phase in tumor cell lines; and 3. It potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Additional targets of iniparib and its metabolites are under investigation. 3-Changes referred to the utilization of tumor biopsies for pharmacogenomic studies: Tumor tissue samples collected for pharmacogenomic purposes were to be transferred under conditions established in the protocol and informed consent from the sponsor to SOLTI group to identify molecular factors of response/resistance to paclitaxel. 4-Changes to the collection of Peripheral Blood Mononuclear Cell (PBMC) collection: Molecular characteristics assessment of the PBMC was removed from second endpoints.

    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.
    Due to discontinuation of program, and as per sponsor's discretion, efficacy endpoints Disease-Free Survival and Overall Survival were not evaluated.
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