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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    Radiation therapy and concurrent plus adjuvant Temsirolimus (CCI-779) versus chemo-irradiation with Temozolomide in newly diagnosed glioblastoma without methylation of the MGMT gene promoter – a randomized multicenter, open-label, Phase II study

    Summary
    EudraCT number
    		 2008-003003-31
    Trial protocol
    		 DE   FR   NL   BE   GB   AT   ES   IT  
    Global end of trial date
    16 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2016
    First version publication date
    28 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EORTC 26082 - 22081
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01019434
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    European Organisation for Research and Treatment of Cancer
    Sponsor organisation address
    Avenue E. Mounier 83/11, Brussels, Belgium, 1200
    Public contact
    Project, Budget and Regulatory Dept, European Organisation for Research and Treatment of Cancer, +32 27441062, regulatory@eortc.be
    Scientific contact
    Project, Budget and Regulatory Dept, European Organisation for Research and Treatment of Cancer, +32 27441062, regulatory@eortc.be
    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
    16 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study’s primary objective is to document the activity profile of Temsirolimus (CCI-779) by the evaluation of overall survival at 12 months (OS12) in patients with newly diagnosed glioblastoma (GBM) without methylation of the MGMT gene promoter, treated with CCI-779 before and concomitantly to radiotherapy (RT), followed by CCI-779 maintenance therapy.
    Protection of trial subjects
    The responsible investigator will ensure that this study is conducted in agreement with either the Declaration of Helsinki (available on the World Medical Association web site (http://www.wma.net)) and/or the laws and regulations of the country, whichever provides the greatest protection of the patient. The protocol has been written, and the study will be conducted according to the ICH Harmonized Tripartite Guideline on Good Clinical Practice (ICH-GCP, available online at http://www.ich.org/LOB/media/MEDIA482.pdf). The protocol must be approved by the competent ethics committee(s) as required by the applicable national legislation.
    Background therapy
    		 Radiotherapy consisted of a conventionally fractionated regimen, delivering a total dose up to 60 Gy, given in individual doses of 2 Gy, 5 days a week. A single phase treatment volume was strongly recommended. Occasionally, in order to keep the dose to the organs at risk (OAR) within tolerance doses, it was necessary to alter shielding partway through the treatment. Wherever possible the dose to the PTV was at least 54 Gy. The radiotherapy had to start within 8 days of randomization and within 7 weeks after surgery or open biopsy.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Dec 2009
    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
    Netherlands: 24
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Switzerland: 19
    Worldwide total number of subjects
    111
    EEA total number of subjects
    92
    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)
    97
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Registration period from 14/12/2009 and 20/09/2012. 15 institutions in 9 countries.

    Pre-assignment
    Screening details
    		 Newly diagnosed histologically proven supratentorial GBM and after screening: Demonstration of an unmethylated MGMT-promotor

    Pre-assignment period milestones
    Number of subjects started
    		 257 [1]
    Number of subjects completed
    		 111

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 24
    Reason: Number of subjects
    		 Methylated MGMT-promotor: 67
    Reason: Number of subjects
    		 Other: 55
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 257 patients were registered in the study but 111 only were eligible for randomization. Results are presented for randomized patients only.
    Period 1
    Period 1 title
    Randomization (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Temozolomide (TMZ)
    Arm description
    		 Study period 1 (concomitant RT-TMZ) and starts within 8 days from randomization: Focal RT to the tumor area will be administered concomitantly to TMZ at a dose of 60 Gy, given in individual doses of 2 Gy per day for 5 days a week over 6 weeks. TMZ will be given at 75 mg/m2 daily for the whole period of RT including weekends as registered. Study period 2 (adjuvant): TMZ administration pauses for 4 weeks from the end of RT and will continue for 6 4-week cycles (D1-5) at 150/200 mg/m2 as detailed in the registration trial and according to the label in this indication. At the investigators discretion TMZ can be continued up to a maximum of 12 cycles.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Temodal
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    Study period 1: TMZ will be given at 75 mg/m2 daily for the whole period of RT including weekends as registered. Study period 2: TMZ administration pauses for 4 weeks from the end of RT and will continue for 6 4-week cycles (D1-5) at 150/200 mg/m2 as detailed in the registration trial and according to the label in this indication.

    Arm title
    		 Temsirolimus (CCI-779)
    Arm description
    		 Study period 1 (concomitant RT-TMZ) and starts within 8 days from randomization: Focal RT to the tumor area will be administered concomitantly to TMZ at a dose of 60 Gy, given in individual doses of 2 Gy per day for 5 days a week over 6 weeks. CCI-779 will be given i.v. once every week at 25 mg. Each treatment should be preceded by supportive medication with a histamine H2-receptor antagonist. A first dose of CCI-779, being 25 mg, will be given on day –7 from RT start. Study period 2 (maintenance): CCI-779 administration (given i.v. once every week at 25 mg) is to continue until progression or unacceptable AEs.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Temsirolimus
    Investigational medicinal product code
    Other name
    Torisel
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Will be given i.v. once every week at 25 mg. Each treatment should be preceded by supportive medication with a histamine H2-receptor antagonist. A first dose of CCI-779 will be given on day –7 from RT start, being 25 mg. CCI-779 administration is to continue until progression or unacceptable AEs.

    Number of subjects in period 1
    		Temozolomide (TMZ) Temsirolimus (CCI-779)
    Started
    55
    56
    Completed
    12
    0
    Not completed
    43
    56
         Consent withdrawn by subject
    3
    1
         Physician decision
    -
    2
         Adverse event, non-fatal
    7
    13
         Other
    3
    4
         treatment ongoing
    -
    1
         Lack of efficacy
    30
    35

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Temozolomide (TMZ)
    Reporting group description
    		 Study period 1 (concomitant RT-TMZ) and starts within 8 days from randomization: Focal RT to the tumor area will be administered concomitantly to TMZ at a dose of 60 Gy, given in individual doses of 2 Gy per day for 5 days a week over 6 weeks. TMZ will be given at 75 mg/m2 daily for the whole period of RT including weekends as registered. Study period 2 (adjuvant): TMZ administration pauses for 4 weeks from the end of RT and will continue for 6 4-week cycles (D1-5) at 150/200 mg/m2 as detailed in the registration trial and according to the label in this indication. At the investigators discretion TMZ can be continued up to a maximum of 12 cycles.

    Reporting group title
    Temsirolimus (CCI-779)
    Reporting group description
    		 Study period 1 (concomitant RT-TMZ) and starts within 8 days from randomization: Focal RT to the tumor area will be administered concomitantly to TMZ at a dose of 60 Gy, given in individual doses of 2 Gy per day for 5 days a week over 6 weeks. CCI-779 will be given i.v. once every week at 25 mg. Each treatment should be preceded by supportive medication with a histamine H2-receptor antagonist. A first dose of CCI-779, being 25 mg, will be given on day –7 from RT start. Study period 2 (maintenance): CCI-779 administration (given i.v. once every week at 25 mg) is to continue until progression or unacceptable AEs.

    Reporting group values
    		 Temozolomide (TMZ) Temsirolimus (CCI-779) Total
    Number of subjects
    		 55 56 111
    Age categorical
    Units: Subjects
        <50 years
    		 15 14 29
        ≥50 years
    		 40 42 82
    Age continuous
    Units: years
        median (full range (min-max))
    		 55.7 (24.4 to 76) 54.9 (28.2 to 74.7) -
    Gender categorical
    Units: Subjects
        Female
    		 19 21 40
        Male
    		 36 35 71
    Steroids use
    Units: Subjects
        No
    		 37 40 77
        yes, stable/decreasing dose
    		 17 16 33
        yes, increasing dose
    		 1 0 1
    WHO performance status
    Units: Subjects
        PS 0
    		 40 32 72
        PS 1
    		 14 20 34
        PS 2
    		 1 4 5

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Temozolomide (TMZ)
    Reporting group description
    		 Study period 1 (concomitant RT-TMZ) and starts within 8 days from randomization: Focal RT to the tumor area will be administered concomitantly to TMZ at a dose of 60 Gy, given in individual doses of 2 Gy per day for 5 days a week over 6 weeks. TMZ will be given at 75 mg/m2 daily for the whole period of RT including weekends as registered. Study period 2 (adjuvant): TMZ administration pauses for 4 weeks from the end of RT and will continue for 6 4-week cycles (D1-5) at 150/200 mg/m2 as detailed in the registration trial and according to the label in this indication. At the investigators discretion TMZ can be continued up to a maximum of 12 cycles.

    Reporting group title
    Temsirolimus (CCI-779)
    Reporting group description
    		 Study period 1 (concomitant RT-TMZ) and starts within 8 days from randomization: Focal RT to the tumor area will be administered concomitantly to TMZ at a dose of 60 Gy, given in individual doses of 2 Gy per day for 5 days a week over 6 weeks. CCI-779 will be given i.v. once every week at 25 mg. Each treatment should be preceded by supportive medication with a histamine H2-receptor antagonist. A first dose of CCI-779, being 25 mg, will be given on day –7 from RT start. Study period 2 (maintenance): CCI-779 administration (given i.v. once every week at 25 mg) is to continue until progression or unacceptable AEs.

    Primary: Overall survival rate at 12 months (OS12)

    		 Close Top of page
    End point title
    		 Overall survival rate at 12 months (OS12) [1] [2]
    End point description
    The primary endpoint (OS12) is evaluated only in the Temsirolimus (CCI-779) arm, in the per protocol population (All patients who are eligible and have started their allocated treatment with at least one dose of the study drug) The number of patients alive at 1 year will be computed. Patients lost to follow-up or who died before 1 year are considered as failures at the time of analysis. In case more than 54 eligible patients are recruited in Temsirolimus (CCI-779) arm, the decision rule will be applied as such on the first 54 eligible patients according to their sequential registration numbers.
    End point type
    Primary
    End point timeframe
    All patients will be observed during a minimum follow-up of 1 year.
    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: This is a non comparative phase II design, no formal statistical test was performed for the primary endpoint. In the per protocol population, exactly 38 patients treated with CCI-779 (out of 54 eligible) had survived up to 1 year. At least 39 patients were needed to reach the targeted drug activity. The trial was analysed with the conclusion that the therapeutic activity of Temsirolimus (CCI-779) is too low in this disease.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The decision rule defined above was only applied to the treatment arm (CCI-779).
    End point values
    		 Temsirolimus (CCI-779)
    Number of subjects analysed
    54
    Units: patients
    number (not applicable)
        Failure
    16
        Success (alive at 12 months)
    38
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

    		 Close Top of page
    End point title
    		 Overall Survival (OS)
    End point description
    The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination. All patients will be followed until death. Overall survival will be described in the intent-to-treat population (all randomized patients according to the allocated treatment).
    End point type
    Secondary
    End point timeframe
    All patients will have three monthly disease and status assessment after the end of RT until PD or start of further anti tumoral therapy. After the documentation of first progression, the patient must be followed every 3 months till death.
    End point values
    		 Temozolomide (TMZ) Temsirolimus (CCI-779)
    Number of subjects analysed
    55
    56
    Units: Months
        median (confidence interval 95%)
    16 (13.8 to 18.2)
    14.8 (13.3 to 16.4)
    Statistical analysis title
    		 Comparison of OS in ITT
    Statistical analysis description
    Sensitivity analysis Comparison of overall survival (CCI-779 versus TMZ) in the intent-to-treat population (all randomized patients according to the allocated treatment).
    Comparison groups
    Temozolomide (TMZ) v Temsirolimus (CCI-779)
    Number of subjects included in analysis
    111
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.47
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.76

    Secondary: Progression-free survival (PFS)

    		 Close Top of page
    End point title
    		 Progression-free survival (PFS)
    End point description
    Progression free survival (PFS) will be measured from the date of randomization until the date of objective progression or the date of patient's death whichever occurs first. Patients without evidence of progression will be censored at the date of last tumor assessment where non progression was documented. If a patient received a second anti-cancer therapy without prior documentation of disease progression, the patient will be censored at the date of last tumor assessment before starting new anti tumoral therapy.
    End point type
    Secondary
    End point timeframe
    All patients will have three monthly disease and status assessment after the end of radiotherapy until progression or start of further anti-tumoral therapy.
    End point values
    		 Temozolomide (TMZ) Temsirolimus (CCI-779)
    Number of subjects analysed
    55
    56
    Units: Months
        median (confidence interval 95%)
    5.95 (3.25 to 8.02)
    5.36 (3.71 to 6.14)
    Statistical analysis title
    		 Comparison of PFS in ITT
    Statistical analysis description
    Sensitivity analysis Comparison of progression-free survival (CCI-779 versus TMZ) in the intent-to-treat population (all randomized patients according to the allocated treatment).
    Comparison groups
    Temozolomide (TMZ) v Temsirolimus (CCI-779)
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.236
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.86

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Before treatment start, at week 4 and 6 of RT, 4 weeks after the end of RT. Three monthly disease evaluation after the end of RT. Every 4 weeks for CCI-779/every adjuvant cycle for TMZ.
    Adverse event reporting additional description
    CRF for AEs contains pre-specified items + additional boxes for all "other" AEs. (xx% AEs are reported as "other" and are not reported as not available from the list of SOC). AEs are evaluated using CTC grading, SAEs using MedDra. Non-SAEs has not been collected specifically, all AEs will be reported in non-SAE section.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    TMZ in safety
    Reporting group description
    		 TMZ in safety population

    Reporting group title
    CCI-779 in safety
    Reporting group description
    		 CCI-779 in safety population

    Serious adverse events
    		 TMZ in safety CCI-779 in safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 53 (28.30%)
    26 / 55 (47.27%)
         number of deaths (all causes)
    43
    46
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Hypertension
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chills
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    4 / 55 (7.27%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic injury
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Aphasia
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balance disorder
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain oedema
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar syndrome
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal fluid retention
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complex partial seizures
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Stomatitis
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatitis
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin toxicity
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii infection
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Urinary tract infection
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercholesterolaemia
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertriglyceridaemia
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 TMZ in safety CCI-779 in safety
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 53 (100.00%)
    55 / 55 (100.00%)
    Investigations
    HYPER ALKALINE PHOSPHATASE
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    7 / 53 (13.21%)
    7 / 55 (12.73%)
         occurrences all number
    7
    7
    HYPER ALT
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    30 / 53 (56.60%)
    40 / 55 (72.73%)
         occurrences all number
    30
    40
    HYPER GGT
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    25 / 53 (47.17%)
    33 / 55 (60.00%)
         occurrences all number
    25
    33
    HYPER AST
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    19 / 53 (35.85%)
    25 / 55 (45.45%)
         occurrences all number
    19
    25
    HYPERBILIRUBINEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    6 / 53 (11.32%)
    2 / 55 (3.64%)
         occurrences all number
    6
    2
    HYPERCALCAEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    6 / 53 (11.32%)
    4 / 55 (7.27%)
         occurrences all number
    6
    4
    HYPERCHOLESTEROLEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    23 / 53 (43.40%)
    47 / 55 (85.45%)
         occurrences all number
    23
    47
    HYPERCREATININEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    13 / 53 (24.53%)
    6 / 55 (10.91%)
         occurrences all number
    13
    6
    HYPERGLYCEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    26 / 53 (49.06%)
    36 / 55 (65.45%)
         occurrences all number
    26
    36
    HYPERKALEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    14 / 53 (26.42%)
    7 / 55 (12.73%)
         occurrences all number
    14
    7
    HYPERMAGNESIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    5 / 53 (9.43%)
    2 / 55 (3.64%)
         occurrences all number
    5
    2
    HYPERPHOSPHATEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    9 / 53 (16.98%)
    28 / 55 (50.91%)
         occurrences all number
    9
    28
    HYPOCALCAEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    8 / 53 (15.09%)
    14 / 55 (25.45%)
         occurrences all number
    8
    14
    HYPERTRIGLYCERIDEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    36 / 53 (67.92%)
    51 / 55 (92.73%)
         occurrences all number
    36
    51
    HYPOGLYCEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 55 (5.45%)
         occurrences all number
    4
    3
    HYPOKALEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    5 / 53 (9.43%)
    18 / 55 (32.73%)
         occurrences all number
    5
    18
    HYPOMAGNESIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    9 / 55 (16.36%)
         occurrences all number
    1
    9
    WEIGHT GAIN
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    9 / 53 (16.98%)
    6 / 55 (10.91%)
         occurrences all number
    9
    6
    WEIGHT LOSS
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    6 / 53 (11.32%)
    13 / 55 (23.64%)
         occurrences all number
    6
    13
    Vascular disorders
    FLUSHING
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    HYPERTENSION
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    9 / 53 (16.98%)
    9 / 55 (16.36%)
         occurrences all number
    9
    9
    Cardiac disorders
    CONSTIPATION
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    8 / 53 (15.09%)
    6 / 55 (10.91%)
         occurrences all number
    8
    6
    DIARRHEA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 53 (5.66%)
    13 / 55 (23.64%)
         occurrences all number
    3
    13
    DYSPEPSIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 53 (5.66%)
    4 / 55 (7.27%)
         occurrences all number
    3
    4
    MUCOSITIS ORAL
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    25 / 55 (45.45%)
         occurrences all number
    1
    25
    NAUSEA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    22 / 53 (41.51%)
    12 / 55 (21.82%)
         occurrences all number
    22
    12
    VENTRICULAR ARRHYTHMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    VOMITING
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    10 / 53 (18.87%)
    7 / 55 (12.73%)
         occurrences all number
    10
    7
    Nervous system disorders
    DIZZINESS
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    11 / 53 (20.75%)
    13 / 55 (23.64%)
         occurrences all number
    11
    13
    DYSGEUSIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    4 / 53 (7.55%)
    13 / 55 (23.64%)
         occurrences all number
    4
    13
    EDEMA CEREBRAL
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 55 (1.82%)
         occurrences all number
    2
    1
    HEADACHE
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    20 / 53 (37.74%)
    24 / 55 (43.64%)
         occurrences all number
    20
    24
    PARESTHESIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 53 (5.66%)
    3 / 55 (5.45%)
         occurrences all number
    3
    3
    PERIPHERAL MOTOR NEUROPATHY
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    8 / 53 (15.09%)
    8 / 55 (14.55%)
         occurrences all number
    8
    8
    PERIPHERAL SENSORY NEUROPATHY
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 55 (5.45%)
         occurrences all number
    2
    3
    Blood and lymphatic system disorders
    ANEMIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    5 / 53 (9.43%)
    5 / 55 (9.09%)
         occurrences all number
    5
    5
    FEBRILE NEUTROPENIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    LEUKOPENIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    9 / 53 (16.98%)
    4 / 55 (7.27%)
         occurrences all number
    9
    4
    LYMPHOCYTOPENIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    32 / 53 (60.38%)
    26 / 55 (47.27%)
         occurrences all number
    32
    26
    NEUTROPENIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    8 / 53 (15.09%)
    3 / 55 (5.45%)
         occurrences all number
    8
    3
    THROMBOCYTOPENIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    6 / 53 (11.32%)
    3 / 55 (5.45%)
         occurrences all number
    6
    3
    General disorders and administration site conditions
    EDEMA LIMBS
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    7 / 53 (13.21%)
    6 / 55 (10.91%)
         occurrences all number
    7
    6
    FATIGUE
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    40 / 53 (75.47%)
    43 / 55 (78.18%)
         occurrences all number
    40
    43
    FEVER
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    5 / 53 (9.43%)
    16 / 55 (29.09%)
         occurrences all number
    5
    16
    LOCALIZED EDEMA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 53 (3.77%)
    6 / 55 (10.91%)
         occurrences all number
    2
    6
    NON-CARDIAC CHEST PAIN
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    ALLERGIC RHINITIS
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    2
    COUGH
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 53 (3.77%)
    16 / 55 (29.09%)
         occurrences all number
    2
    16
    DYSPNEA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 53 (5.66%)
    9 / 55 (16.36%)
         occurrences all number
    3
    9
    EPISTAXIS
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    5 / 55 (9.09%)
         occurrences all number
    0
    5
    PNEUMONITIS
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 55 (9.09%)
         occurrences all number
    3
    5
    Skin and subcutaneous tissue disorders
    ALOPECIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    33 / 53 (62.26%)
    28 / 55 (50.91%)
         occurrences all number
    33
    28
    ERYTHEMA MULTIFORME
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 53 (5.66%)
    8 / 55 (14.55%)
         occurrences all number
    3
    8
    NAIL DISCOLORATION
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    2
    NAIL LOSS
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    2
    NAIL RIDGING
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    2
    PERIORBITAL EDEMA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    4 / 55 (7.27%)
         occurrences all number
    0
    4
    PRURITUS
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 53 (3.77%)
    10 / 55 (18.18%)
         occurrences all number
    2
    10
    RASH ACNEIFORM
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    18 / 55 (32.73%)
         occurrences all number
    0
    18
    RASH MACULO-PAPULAR
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    9 / 55 (16.36%)
         occurrences all number
    0
    9
    URTICARIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Psychiatric disorders
    AGITATION
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    0
    3
    ANXIETY
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    7 / 55 (12.73%)
         occurrences all number
    0
    7
    CONFUSION
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 53 (3.77%)
    7 / 55 (12.73%)
         occurrences all number
    2
    7
    DEPRESSION
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    6 / 53 (11.32%)
    7 / 55 (12.73%)
         occurrences all number
    6
    7
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 53 (3.77%)
    7 / 55 (12.73%)
         occurrences all number
    2
    7
    BACK PAIN
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 53 (5.66%)
    8 / 55 (14.55%)
         occurrences all number
    3
    8
    Infections and infestations
    CATHETER RELATED INFECTION
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2
    PHARYNGITIS
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    RHINITIS INFECTIVE
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    0 / 53 (0.00%)
    5 / 55 (9.09%)
         occurrences all number
    0
    5
    UPPER RESPIRATORY INFECTION
    Additional description: No information.
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 53 (3.77%)
    4 / 55 (7.27%)
         occurrences all number
    2
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jun 2009
    Protocol version 2.0 dated 25 JUN 2009 In this amendment: • An exclusion criterion on hypersensitivity to antihistamines was added on request of the VHP. The rationale for this is the need to take antihistamines before administration of Temsirolimus. Therefore, it should be clarified to protect the patients, that subjects with a hypersensitivity to antihistamines or with medical reasons that don’t allow the subjects to take antihistamines can’t be included in the study. • The procedure for stopping in case of toxicity was clarified (prolongation of QT interval) • It was clarified that the information on anonymization and sample destruction in the informed consents handles about biological samples as wel (and not only medical data)l. • The details of sample storage and the central laboratory were clarified in the PIS.
    06 Dec 2010
    Protocol version 3.0 dated 06 DEC 2010 The reasons for this amendment are: • Need for modification of the protocol and the Patient Information Sheet according to new safety information. • The participating sites had difficulties to be compliant with time of 8 days between randomization and the start of Radiotherapy (RT). This 8-days period has been removed. The RT now has to start within 7 weeks (49 days) of surgery or open biopsy. • The company MDX Health (OMS) in Liège – Belgium is added as testing center for the MGMT test.

    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/27143690
    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 Apr 26 18:33:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA