Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A RANDOMIZED CONTROLLED STUDY ON THE EFFECTIVENESS OF FIRST-LINE CHEMOTHERAPY (CARBOPLATIN AND PACLITAXEL) VERSUS CHEMO-IMMUNOTHERAPY (CARBOPLATIN-PACLITAXEL-OREGOVOMAB) IN PATIENTS WITH ADVANCED EPITHELIAL OVARIAN, ADNEXAL OR PERITONEAL CARCINOMA

    Summary
    EudraCT number
    2010-024305-13
    Trial protocol
    IT  
    Global end of trial date
    12 Oct 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Oct 2021
    First version publication date
    16 Oct 2021
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    QPT-ORE-02
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01616303
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    OncoQuest Pharmaceuticals Inc.
    Sponsor organisation address
    670-21 Sannae-ro, Sannae-myeon Miryang-Si, Korea, Republic of,
    Public contact
    Thomas Woo, VP of Product Development, OncoQuest Pharmaceuticals Inc., 1 780 448 1400, thomas@oncoquestinc.com
    Scientific contact
    Thomas Woo, VP of Product Development, OncoQuest Pharmaceuticals Inc., 1 780 448 1400, thomas@oncoquestinc.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 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Confirm and clarify the preliminary results of Braly8 on the induction of CA125-specific cellular immunity of clinical relevance with Oregovomab infusion associated with first-line chemotherapy in patients with stage III-IV ovarian cancer. The primary objective of the clinical trial is the evaluation of anti CA125 cellular immune response by ELISPOT assay.
    Protection of trial subjects
    Each enrolled patient was carefully monitored for any potential adverse events from the study treatment. If any adverse events were happened, patients were treated accordingly. Insurance was also provided.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Dec 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 81
    Country: Number of subjects enrolled
    United States: 16
    Worldwide total number of subjects
    97
    EEA total number of subjects
    81
    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)
    72
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    A total of 137 patients were screened, and 40 failed screening. A total of 97 patients were randomly assigned to treatment, and 94 were treated; 91 patients entered follow-up. Eight patients (17.0%) in Arm 1 and 12 patients (24.0%) in Arm 2 discontinued from the study.

    Pre-assignment
    Screening details
    Patients were screened for eligibility up to 4 weeks before treatment. Informed consent was obtained before any protocol-specific screening evaluations were done. Once all eligibility criteria were met, the patient was randomly assigned to a treatment arm. The treatment period began immediately after randomization.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Treatment Arm 1
    Arm description
    Treatment Arm 1 (40 patients planned) received, sequentially on the same day, carboplatin area under the curve (AUC) 6 administered intravenously (IV) every 3 weeks (21 days) for 6 cycles, paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles, and oregovomab 2 mg infused IV over 20 minutes administered during the first, third, and fifth cycles. Patients in Arm 1 also received oregovomab as monotherapy 12 weeks after the fifth cycle. At the discretion of the investigator, treatment with oregovomab may have been discontinued for patients who experienced an allergic event. No other oregovomab dosage modification was permitted without prior approval from the medical monitor. Oregovomab, when dosed at 2 mg, has been demonstrated to induce cross-presentation of CA125 peptide fragments and induce a CA125-specific cellular immune response and has been well tolerated in clinical trials.
    Arm type
    Experimental

    Investigational medicinal product name
    Oregovomab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Oregovomab was supplied in vials containing 2 mg of the monoclonal antibody with a reducing agent, a buffer complex, and excipients. The lyophilized contents of the vial of oregovomab were dissolved in 2 mL of 0.9% sodium chloride injection US Pharmacopeia then added to 50 mL of 0.9% sodium chloride injection USP in a small (50 mL) infusion bag. Paclitaxel was diluted before infusion in 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, or 5% dextrose in Ringer's injection to a final concentration of 0.3 to 1.2 mg/mL. Carboplatin powder was reconstituted for injection with sterile water for injection, dextrose 5% in water, or sodium chloride 0.9 concentration of 10 mg/mL. Reconstituted solution, or premixed aqueous solution, may have been further diluted with dextrose 5% in water or sodium chloride 0.9% injection.

    Investigational medicinal product name
    carboplatin + paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was diluted before infusion in 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, or 5% dextrose in Ringer's injection to a final concentration of 0.3 to 1.2 mg/mL. Carboplatin powder was reconstituted for injection with sterile water for injection, dextrose 5% in water, or sodium chloride 0.9% injection. Diluent was added to produce a solution with a final concentration of 10 mg/mL. Reconstituted solution, or premixed aqueous solution, may have been further diluted with dextrose 5% in water or sodium chloride 0.9% injection

    Arm title
    Treatment Arm 2
    Arm description
    Treatment Arm 2 (40 patients planned) received, sequentially, carboplatin AUC 6 administered IV every 3 weeks (21 days) for 6 cycles, followed by paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles.
    Arm type
    Active comparator

    Investigational medicinal product name
    carboplatin + paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was diluted before infusion in 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, or 5% dextrose in Ringer's injection to a final concentration of 0.3 to 1.2 mg/mL. Carboplatin powder was reconstituted for injection with sterile water for injection, dextrose 5% in water, or sodium chloride 0.9 concentration of 10 mg/mL. Reconstituted solution, or premixed aqueous solution, may have been further diluted with dextrose 5% in water or sodium chloride 0.9% injection.

    Number of subjects in period 1
    Treatment Arm 1 Treatment Arm 2
    Started
    47
    50
    Completed
    39
    38
    Not completed
    8
    12
         Consent withdrawn by subject
    4
    3
         death
    1
    2
         Adverse event, non-fatal
    2
    2
         Patient noncompliance
    1
    2
         none
    -
    2
         Medical condition
    -
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment Arm 1
    Reporting group description
    Treatment Arm 1 (40 patients planned) received, sequentially on the same day, carboplatin area under the curve (AUC) 6 administered intravenously (IV) every 3 weeks (21 days) for 6 cycles, paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles, and oregovomab 2 mg infused IV over 20 minutes administered during the first, third, and fifth cycles. Patients in Arm 1 also received oregovomab as monotherapy 12 weeks after the fifth cycle. At the discretion of the investigator, treatment with oregovomab may have been discontinued for patients who experienced an allergic event. No other oregovomab dosage modification was permitted without prior approval from the medical monitor. Oregovomab, when dosed at 2 mg, has been demonstrated to induce cross-presentation of CA125 peptide fragments and induce a CA125-specific cellular immune response and has been well tolerated in clinical trials.

    Reporting group title
    Treatment Arm 2
    Reporting group description
    Treatment Arm 2 (40 patients planned) received, sequentially, carboplatin AUC 6 administered IV every 3 weeks (21 days) for 6 cycles, followed by paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles.

    Reporting group values
    Treatment Arm 1 Treatment Arm 2 Total
    Number of subjects
    47 50 97
    Age categorical
    The mean and median age of patients in the study was 57.5 and 57.0 years, respectively.
    Units: Subjects
        Adults (18-64 years)
    35 37 72
        From 65-84 years
    12 13 25
    Age continuous
    Units: years
        median (full range (min-max))
    58 (37 to 78) 57 (38 to 75) -
    Gender categorical
    Units: Subjects
        Female
    47 50 97
        Male
    0 0 0
    Race
    Units: Subjects
        African
    0 1 1
        White
    47 49 96
        Asian
    0 0 0
        Other
    0 0 0
    Country
    Units: Subjects
        USA
    8 8 16
        Italy
    39 42 81

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Treatment Arm 1
    Reporting group description
    Treatment Arm 1 (40 patients planned) received, sequentially on the same day, carboplatin area under the curve (AUC) 6 administered intravenously (IV) every 3 weeks (21 days) for 6 cycles, paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles, and oregovomab 2 mg infused IV over 20 minutes administered during the first, third, and fifth cycles. Patients in Arm 1 also received oregovomab as monotherapy 12 weeks after the fifth cycle. At the discretion of the investigator, treatment with oregovomab may have been discontinued for patients who experienced an allergic event. No other oregovomab dosage modification was permitted without prior approval from the medical monitor. Oregovomab, when dosed at 2 mg, has been demonstrated to induce cross-presentation of CA125 peptide fragments and induce a CA125-specific cellular immune response and has been well tolerated in clinical trials.

    Reporting group title
    Treatment Arm 2
    Reporting group description
    Treatment Arm 2 (40 patients planned) received, sequentially, carboplatin AUC 6 administered IV every 3 weeks (21 days) for 6 cycles, followed by paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles.

    Primary: Comparison of CA 125 cellular immune response

    Close Top of page
    End point title
    Comparison of CA 125 cellular immune response
    End point description
    End point type
    Primary
    End point timeframe
    28 weeks
    End point values
    Treatment Arm 1 Treatment Arm 2
    Number of subjects analysed
    34
    29
    Units: percentage
        number (not applicable)
    34
    29
    Statistical analysis title
    Statistical Analysis Plan (SAP)
    Statistical analysis description
    For qualitative variables, the chi-square test was applied. For continuous variables, the Student’s t-test or Wilcoxon-Mann-Whitney test (according to normality of the data) was applied. In both cases, the H0 (null hypothesis) was that there were no differences between groups for a determinate variable. The level of significance was α = 0.05. All descriptive statistical analyses were performed using SAS version 9.4 or later, unless otherwise noted.
    Comparison groups
    Treatment Arm 1 v Treatment Arm 2
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.05
    Method
    Chi-squared
    Parameter type
    percentage
    Confidence interval

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    22 December 2011 to 27 December 2017
    Adverse event reporting additional description
    Monitoring for adverse experiences was conducted by the investigator throughout the study and the results recorded on the AE Report Form.The investigator graded all adverse experiences as to their severity according to the WHO Toxicity Guidelines.All patients followed for AE/SAE for 30days following the last dose or until the date of treatment exit
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Treatment Group
    Reporting group description
    Arm 1: Oregovomab in combination with first-line chemotherapy (carboplatin and pacitaxel) in patients with advanced epithelial ovarian, adnexal, or peritoneal carcinoma. Arm 1 (40 patients planned) received, sequentially on the same day, carboplatin area under the curve (AUC) 6 administered intravenously (IV) every 3 weeks (21 days) for 6 cycles, paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles, and oregovomab 2 mg infused IV over 20 minutes administered during the first, third, and fifth cycles. Patients in Arm 1 also received oregovomab as monotherapy 12 weeks after the fifth cycle.

    Reporting group title
    Control Group
    Reporting group description
    Arm 2: First-line chemotherapy (carboplatin and pacitaxel) in patients with advanced epithelial ovarian, adnexal, or peritoneal carcinoma. Treatment Arm 2 (40 patients planned) received, sequentially, carboplatin AUC 6 administered IV every 3 weeks (21 days) for 6 cycles, followed by paclitaxel 175 mg/m2 IV over 3 hours every 3 weeks for 6 cycles.

    Serious adverse events
    Treatment Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 46 (19.57%)
    7 / 48 (14.58%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    1
    1
    Vascular disorders
    Pelvic venous thrombosis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Reproductive system and breast disorders
    Pelvic fluid collection
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Pleural effusion
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Syncope
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Blood and lymphatic system disorders
    Abdominal lymphadenopathy
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Anaemia
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Febrile neutropenia
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Pancytopenia
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Intestinal infarction
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Localised intraabdominal fluid collection
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Vomiting
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Hepatobiliary disorders
    Cholecystocholangitis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Renal and urinary disorders
    Prerenal failure
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Infections and infestations
    Hepatitis B
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Neutropenic sepsis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Hypomagnesaemia
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Treatment Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 46 (78.26%)
    39 / 48 (81.25%)
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 48 (6.25%)
         occurrences all number
    2
    3
    Paraesthesia
         subjects affected / exposed
    7 / 46 (15.22%)
    9 / 48 (18.75%)
         occurrences all number
    7
    9
    Peripheral sensory neuropathy
         subjects affected / exposed
    4 / 46 (8.70%)
    3 / 48 (6.25%)
         occurrences all number
    4
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    18 / 46 (39.13%)
    15 / 48 (31.25%)
         occurrences all number
    18
    15
    Leukopenia
         subjects affected / exposed
    17 / 46 (36.96%)
    17 / 48 (35.42%)
         occurrences all number
    17
    17
    Neutropenia
         subjects affected / exposed
    21 / 46 (45.65%)
    25 / 48 (52.08%)
         occurrences all number
    21
    25
    Thrombocytopenia
         subjects affected / exposed
    3 / 46 (6.52%)
    5 / 48 (10.42%)
         occurrences all number
    3
    5
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    7 / 46 (15.22%)
    6 / 48 (12.50%)
         occurrences all number
    7
    6
    Fatigue
         subjects affected / exposed
    6 / 46 (13.04%)
    7 / 48 (14.58%)
         occurrences all number
    6
    7
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    8 / 46 (17.39%)
    5 / 48 (10.42%)
         occurrences all number
    8
    5
    Nausea
         subjects affected / exposed
    9 / 46 (19.57%)
    7 / 48 (14.58%)
         occurrences all number
    9
    7
    Vomiting
         subjects affected / exposed
    3 / 46 (6.52%)
    2 / 48 (4.17%)
         occurrences all number
    3
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    8 / 46 (17.39%)
    6 / 48 (12.50%)
         occurrences all number
    8
    6
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 46 (0.00%)
    3 / 48 (6.25%)
         occurrences all number
    0
    3
    Myalgia
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 48 (6.25%)
         occurrences all number
    2
    3
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    3 / 46 (6.52%)
    0 / 48 (0.00%)
         occurrences all number
    3
    0

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Feb 2012
    Updated Protocol
    21 Jul 2012
    Updated Protocol
    07 Sep 2012
    Updated Protocol
    08 Feb 2013
    Updated Protocol

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/31916979
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 02 05:51:25 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA