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    Clinical Trial Results:
    International, Multi-Center, Open-label, Treatment Extension Study of Iniparib as Monotherapy or in Combination Chemotherapeutic Regimens in Cancer Patients Who Have Derived Clinical Benefit From Iniparib Following Completion of a Phase 1, 2 or 3 Parental Study

    Summary
    EudraCT number
    2011-006246-33
    Trial protocol
    BE   ES   IT  
    Global end of trial date
    26 Sep 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Sep 2017
    First version publication date
    13 Sep 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LTS12674
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01593228
    WHO universal trial number (UTN)
    U1111-1127-0888
    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
    24 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in subjects previously treated with iniparib in a clinical study and who had derived clinical benefit after completion of the parental study’s objectives. Parental studies included EFC11553, EFC11614, TCD11484, TED11746 and TCD11418.
    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
    14 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 32
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    35
    EEA total number of subjects
    3
    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)
    28
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 32 study centers in 4 countries between 14 May 2012 and 26 September 2016. This is a safety roll over protocol for subjects who participated in Phase 1, 2 or 3 studies of iniparib given either as monotherapy or as part of a combination regimen. A total of 35 subjects were treated.

    Pre-assignment
    Screening details
    Iniparib was given either as monotherapy or as part of a combination regimen, to subjects who participated in Phase 1, 2 or 3 studies and completed assessments for primary objectives and who would benefit from continuation therapy of iniparib as per investigator’s decision.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Iniparib Monotherapy
    Arm description
    Subjects received Iniparib as monotherapy according to the dose and schedule as in their parental study (Phase 1, 2 or 3 studies).
    Arm type
    Experimental

    Investigational medicinal product name
    Iniparib
    Investigational medicinal product code
    SAR240550
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Iniparib was administered as intravenous infusion at the same dose and schedule as in their parental study (Phase 1, 2 or 3 studies).

    Arm title
    Iniparib Combination Therapy
    Arm description
    Subjects received Iniparib as combination regimen with other anti-cancer agents according to the dose and schedule as in their parental study (Phase 1, 2 or 3 studies).
    Arm type
    Experimental

    Investigational medicinal product name
    Iniparib
    Investigational medicinal product code
    SAR240550
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Iniparib was administered as monotherapy or in combination with other anti-cancer agents as intravenous injection at the same dose and schedule as in their parental study (Phase 1, 2 or 3 studies). Combination therapy included Iniparib + gemcitabine + carboplatin; Iniparib + topotecan; Iniparib + irinotecan; Iniparib + paclitaxel; Iniparib + liposomal doxorubicin + carboplatin.

    Number of subjects in period 1
    Iniparib Monotherapy Iniparib Combination Therapy
    Started
    11
    24
    Completed
    0
    0
    Not completed
    11
    24
         Other than specified
             5
             10
         Poor compliance to protocol
             -
             1
         Adverse events
             -
             3
         Disease progression
             6
             10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Iniparib Monotherapy
    Reporting group description
    Subjects received Iniparib as monotherapy according to the dose and schedule as in their parental study (Phase 1, 2 or 3 studies).

    Reporting group title
    Iniparib Combination Therapy
    Reporting group description
    Subjects received Iniparib as combination regimen with other anti-cancer agents according to the dose and schedule as in their parental study (Phase 1, 2 or 3 studies).

    Reporting group values
    Iniparib Monotherapy Iniparib Combination Therapy Total
    Number of subjects
    11 24 35
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.9 ± 12.1 53.8 ± 14.1 -
    Gender categorical
    Units: Subjects
        Female
    10 22 32
        Male
    1 2 3

    End points

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    End points reporting groups
    Reporting group title
    Iniparib Monotherapy
    Reporting group description
    Subjects received Iniparib as monotherapy according to the dose and schedule as in their parental study (Phase 1, 2 or 3 studies).

    Reporting group title
    Iniparib Combination Therapy
    Reporting group description
    Subjects received Iniparib as combination regimen with other anti-cancer agents according to the dose and schedule as in their parental study (Phase 1, 2 or 3 studies).

    Primary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events

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    End point title
    Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events [1]
    End point description
    Any untoward medical occurrence in a subject who received study drug was considered an AE without regard to possibility of causal relationship with treatment. TEAEs were AEs developed or worsened or became serious during on-treatment period (time from first dose of study drug up to 30 days after last dose of study drug). Serious adverse event (SAE) were any untoward medical occurrence that resulted in any of following outcomes: death,life-threatening,required initial or prolonged in-patient 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.All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.4.03 scale. Safety population included any subject who received at least one dose of study drug as single agent or as combination therapy.
    End point type
    Primary
    End point timeframe
    Baseline up to 30 days after last dose of study drug (maximum exposure: 204 weeks)
    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
    Iniparib Monotherapy Iniparib Combination Therapy
    Number of subjects analysed
    11
    24
    Units: subjects
        Any TEAEs
    10
    24
        SAEs
    4
    7
    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: 204 weeks) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    TEAEs are defined as AEs that developed/worsened during ‘on treatment period’ (time from first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population that included any subject who received at least one dose of study drug as single agent or as combination therapy.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Iniparib Monotherapy
    Reporting group description
    Subjects received Iniparib as monotherapy according to the dose and schedule as in their parental study (Phase 1, 2 or 3 studies).

    Reporting group title
    Iniparib Combination Therapy
    Reporting group description
    Subjects received Iniparib as combination regimen with other anti-cancer agents according to the dose and schedule as in their parental study (Phase 1, 2 or 3 studies).

    Serious adverse events
    Iniparib Monotherapy Iniparib Combination Therapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 11 (36.36%)
    7 / 24 (29.17%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Ankle Fracture
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases To Central Nervous System
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 24 (12.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile Neutropenia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Oedema
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure Like Phenomena
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional State
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental Status Changes
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis Acute
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Iniparib Monotherapy Iniparib Combination Therapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 11 (90.91%)
    24 / 24 (100.00%)
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    2
    2
    Hot Flush
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 24 (8.33%)
         occurrences all number
    1
    3
    Lymphoedema
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Hypotension
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic Keratosis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Basal Cell Carcinoma
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Drug Hypersensitivity
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Axillary Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Asthenia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Chills
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Catheter Site Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 11 (18.18%)
    10 / 24 (41.67%)
         occurrences all number
    4
    20
    Gait Disturbance
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Impaired Healing
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Influenza Like Illness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    3
    Malaise
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 24 (16.67%)
         occurrences all number
    1
    4
    Oedema Peripheral
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 24 (8.33%)
         occurrences all number
    2
    2
    Pyrexia
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    Psychiatric disorders
    Affect Lability
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    3 / 11 (27.27%)
    4 / 24 (16.67%)
         occurrences all number
    4
    4
    Reproductive system and breast disorders
    Pruritus Genital
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Breast Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Vulvovaginal Dryness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Animal Bite
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    2
    3
    Foot Fracture
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Infusion Related Reaction
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    3
    Procedural Dizziness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Laceration
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Procedural Site Reaction
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Tooth Fracture
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Wound Dehiscence
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Blood Creatinine Increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Haemoglobin Decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    12
    Blood Pressure Increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Neutrophil Count Decreased
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 24 (8.33%)
         occurrences all number
    8
    11
    Lipase Increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Weight Decreased
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 24 (8.33%)
         occurrences all number
    1
    4
    Platelet Count Decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 24 (12.50%)
         occurrences all number
    0
    18
    White Blood Cell Count Decreased
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    5
    2
    Weight Increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    6
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Sinus Tachycardia
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 24 (8.33%)
         occurrences all number
    1
    2
    Palpitations
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 11 (36.36%)
    7 / 24 (29.17%)
         occurrences all number
    9
    9
    Dysphonia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    3 / 11 (27.27%)
    6 / 24 (25.00%)
         occurrences all number
    6
    7
    Epistaxis
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 24 (8.33%)
         occurrences all number
    1
    2
    Dyspnoea Exertional
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    4 / 24 (16.67%)
         occurrences all number
    0
    4
    Nasal Congestion
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Pleural Effusion
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Rhinitis Allergic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Upper-Airway Cough Syndrome
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Wheezing
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 24 (16.67%)
         occurrences all number
    3
    14
    Increased Tendency To Bruise
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    11
    Thrombocytopenia
         subjects affected / exposed
    1 / 11 (9.09%)
    10 / 24 (41.67%)
         occurrences all number
    1
    38
    Neutropenia
         subjects affected / exposed
    0 / 11 (0.00%)
    8 / 24 (33.33%)
         occurrences all number
    0
    29
    Nervous system disorders
    Brain Oedema
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Cognitive Disorder
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Dizziness Postural
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    3 / 11 (27.27%)
    4 / 24 (16.67%)
         occurrences all number
    7
    5
    Facial Paralysis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 11 (9.09%)
    6 / 24 (25.00%)
         occurrences all number
    2
    10
    Generalised Tonic-Clonic Seizure
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Hemiparesis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Myoclonus
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Seizure
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Somnolence
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Eye disorders
    Lacrimation Increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Vision Blurred
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    Periorbital Oedema
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear Discomfort
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Ear Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Tinnitus
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Abdominal Discomfort
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Abdominal Pain
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 24 (8.33%)
         occurrences all number
    2
    2
    Constipation
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 24 (8.33%)
         occurrences all number
    2
    2
    Diarrhoea
         subjects affected / exposed
    2 / 11 (18.18%)
    6 / 24 (25.00%)
         occurrences all number
    5
    9
    Duodenal Ulcer
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Glossodynia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Mouth Ulceration
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    3 / 11 (27.27%)
    8 / 24 (33.33%)
         occurrences all number
    5
    16
    Oral Discomfort
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Oral Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Paraesthesia Oral
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Tongue Ulceration
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 24 (8.33%)
         occurrences all number
    8
    3
    Toothache
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    3 / 11 (27.27%)
    6 / 24 (25.00%)
         occurrences all number
    4
    11
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Pollakiuria
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Urine Odour Abnormal
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatic Function Abnormal
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Dry Skin
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Alopecia
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Dermatitis Contact
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Ecchymosis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Macule
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Ingrowing Nail
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Nail Discolouration
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Onycholysis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Onychomadesis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Pain Of Skin
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    Pruritus Generalised
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Palmar Erythema
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Psoriasis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Rash Macular
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Rash Maculo-Papular
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Rash Vesicular
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 24 (16.67%)
         occurrences all number
    1
    5
    Back Pain
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 24 (8.33%)
         occurrences all number
    1
    2
    Bone Pain
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 24 (8.33%)
         occurrences all number
    7
    2
    Exostosis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Flank Pain
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Fracture Pain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Muscular Weakness
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 24 (12.50%)
         occurrences all number
    1
    3
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 24 (8.33%)
         occurrences all number
    2
    2
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    3
    Neck Pain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 24 (8.33%)
         occurrences all number
    1
    2
    Osteonecrosis Of Jaw
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Pain In Extremity
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 24 (12.50%)
         occurrences all number
    1
    3
    Pain In Jaw
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Endocrine disorders
    Adrenal Insufficiency
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Hypothyroidism
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    2 / 11 (18.18%)
    3 / 24 (12.50%)
         occurrences all number
    3
    3
    Hypercalcaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Ear Infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Cystitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Fungal Skin Infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    Herpes Zoster
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 24 (12.50%)
         occurrences all number
    1
    3
    Gastrointestinal Infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Hordeolum
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Implant Site Infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Infected Bite
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Lung Infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Oral Herpes
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 24 (8.33%)
         occurrences all number
    2
    2
    Oral Candidiasis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Sinusitis
         subjects affected / exposed
    0 / 11 (0.00%)
    4 / 24 (16.67%)
         occurrences all number
    0
    8
    Pharyngitis Streptococcal
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    4
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 11 (18.18%)
    5 / 24 (20.83%)
         occurrences all number
    2
    10
    Viral Infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    The purpose of trial was to provide subjects with an opportunity to continue iniparib treatment after completing parental trials. As such, safety results in this study do not fully reflect safety profile of drug given in monotherapy or in combination
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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