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   43873   clinical trials with a EudraCT protocol, of which   7293   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 multicenter, open-label, randomized phase II study to evaluate the efficacy of AUY922 vs. emetrexed or docetaxel in NSCLC patients with EGFR mutations who have progressed on prior EGFR TKI treatmen

    Summary
    EudraCT number
    		 2012-001050-25
    Trial protocol
    		 ES   GB   NO   NL   FR   IT   PL  
    Global end of trial date
    25 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2016
    First version publication date
    19 Nov 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAUY922A2207
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01646125
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    25 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to compare progression-free survival (PFS) in patients treated with AUY922 versus pemetrexed or docetaxel.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Hong Kong: 4
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Japan: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Netherlands: 9
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Taiwan: 5
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    59
    EEA total number of subjects
    41
    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)
    36
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 59 patients were randomized in the study: 31 to the AUY922 arm and 28 to the chemotherapy arm. 2 patients from the AUY922 arm & 5 from the chemotherapy arm were not treated.

    Pre-assignment
    Screening details
    		 Patients were randomized in a 1:1 ratio to receive either AUY922 or pemetrexed/docetaxel. The control arm treatment was defined as either pemetrexed or docetaxel (at the Investigator’s discretion) as they were standard chemotherapeutic agents and were approved for use in patients with advanced NSCLC who had progressed on 1 prior line of treatment

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AUY922 arm
    Arm description
    		 Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm. AUY922 was to be administered weekly.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AUY922
    Investigational medicinal product code
    AUY922
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The investigational drug was AUY922 and the mode of administration was intravenous. The dose of AUY922 used in the study was 70 mg/m2 once a week.

    Arm title
    		 Chemotherapy arm
    Arm description
    		 Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm. Pemetrexed or docetaxel was to be was to be given once every three weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed 500 mg/m2 every 3 weeks for intravenous use.

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel 75 mg/m2 every 3 weeks for intravenous use.

    Number of subjects in period 1
    		AUY922 arm Chemotherapy arm
    Started
    31
    28
    Completed
    0
    0
    Not completed
    31
    28
         Adverse event, serious fatal
    1
    1
         Physician decision
    1
    3
         Adverse event, non-fatal
    2
    1
         Untreated
    2
    5
         Study terminated by sponsor
    2
    1
         Subject/Guardian decision
    1
    1
         Progressive disease
    22
    16

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    AUY922 arm
    Reporting group description
    		 Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm. AUY922 was to be administered weekly.

    Reporting group title
    Chemotherapy arm
    Reporting group description
    		 Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm. Pemetrexed or docetaxel was to be was to be given once every three weeks.

    Reporting group values
    		 AUY922 arm Chemotherapy arm Total
    Number of subjects
    		 31 28 59
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 20 16 36
        From 65-84 years
    		 11 12 23
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 61.8 ( 10.1 ) 62.1 ( 10.34 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 27 21 48
        Male
    		 4 7 11

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    AUY922 arm
    Reporting group description
    		 Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm. AUY922 was to be administered weekly.

    Reporting group title
    Chemotherapy arm
    Reporting group description
    		 Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm. Pemetrexed or docetaxel was to be was to be given once every three weeks.

    Primary: Progression Free Survival (PFS) at Interim Analysis (IA)

    		 Close Top of page
    End point title
    		 Progression Free Survival (PFS) at Interim Analysis (IA)
    End point description
    Compared PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. Progression-free survival (PFS) based on local investigator assessment per RECIST 1.1 was the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
    End point type
    Primary
    End point timeframe
    16 months
    End point values
    		 AUY922 arm Chemotherapy arm
    Number of subjects analysed
    19
    17
    Units: Months
        median (confidence interval 90%)
    1.5 (1.2 to 5.6)
    2.3 (1.2 to 4)
    Statistical analysis title
    		 Posterior predictive probability for PFS
    Comparison groups
    Chemotherapy arm v AUY922 arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.76
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 1.63

    Secondary: Overall Response Rate (ORR) at Interim analysis

    		 Close Top of page
    End point title
    		 Overall Response Rate (ORR) at Interim analysis
    End point description
    ORR was to be compared between treatment arms. The ORR was to be based on local investigator assessment per RECIST 1.1. This outcome measure was originally planned to be analyzed up to 24 months.
    End point type
    Secondary
    End point timeframe
    16 months
    End point values
    		 AUY922 arm Chemotherapy arm
    Number of subjects analysed
    19
    17
    Units: subjects
        Complete Response (CR)
    0
    0
        Partial Response (PR)
    3
    2
        ORR (CR + PR)
    3
    2
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

    		 Close Top of page
    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the time from the date of randomization to date of death due to any cause. If a death had not been observed by the date of analysis cutoff, then OS was to be censored at the last known date patient was alive.
    End point type
    Secondary
    End point timeframe
    from randomization until death up to death
    End point values
    		 AUY922 arm Chemotherapy arm
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: months
        arithmetic mean (confidence interval 90%)
    ( to )
    ( to )
    Notes
    [1] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped.
    [2] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped.
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR)

    		 Close Top of page
    End point title
    		 Disease Control Rate (DCR)
    End point description
    Duration of DCR was to be compared between treatment arms. The duration of DCR was to be based on local investigator assessment per RECIST 1.1.
    End point type
    Secondary
    End point timeframe
    baseline, until disease progression up to 24 months
    End point values
    		 AUY922 arm Chemotherapy arm
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: subjects
        number (confidence interval 90%)
    ( to )
    ( to )
    Notes
    [3] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped.
    [4] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped.
    No statistical analyses for this end point

    Secondary: Time to Response (TRR)

    		 Close Top of page
    End point title
    		 Time to Response (TRR)
    End point description
    TTR was to compare between treatment arms. The TTR was to be based on local investigator assessment per RECIST 1.1
    End point type
    Secondary
    End point timeframe
    baseline, until disease progression up to 24 months
    End point values
    		 AUY922 arm Chemotherapy arm
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: months
        median (confidence interval 90%)
    ( to )
    ( to )
    Notes
    [5] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped.
    [6] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped.
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

    		 Close Top of page
    End point title
    		 Duration of Response (DOR)
    End point description
    The DOR was to be compared between treatment arms. The DOR was to be based on local investigator assessment per RECIST 1.1
    End point type
    Secondary
    End point timeframe
    baseline, until disease progression up to 24 months
    End point values
    		 AUY922 arm Chemotherapy arm
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: months
        median (confidence interval 90%)
    ( to )
    ( to )
    Notes
    [7] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped
    [8] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped.
    No statistical analyses for this end point

    Secondary: Rate of Adverse Events (AEs)

    		 Close Top of page
    End point title
    		 Rate of Adverse Events (AEs)
    End point description
    To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel. See safety section for safety data.
    End point type
    Secondary
    End point timeframe
    baseline, until disease progression up to 24 months
    End point values
    		 AUY922 arm Chemotherapy arm
    Number of subjects analysed
    29
    23
    Units: subjects
    29
    23
    No statistical analyses for this end point

    Secondary: Change in laboratory paramenters

    		 Close Top of page
    End point title
    		 Change in laboratory paramenters
    End point description
    Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity.
    End point type
    Secondary
    End point timeframe
    baseline, until disease progression up to 24 months
    End point values
    		 AUY922 arm Chemotherapy arm
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: subjects
    Notes
    [9] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped.
    [10] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped.
    No statistical analyses for this end point

    Secondary: Time to Progression (TTP)

    		 Close Top of page
    End point title
    		 Time to Progression (TTP)
    End point description
    TTP was to be compared between treatment arms. The TTP was to be based on local investigator assessment per RECIST 1.1.
    End point type
    Secondary
    End point timeframe
    baseline, until disease progression up to 24 months
    End point values
    		 AUY922 arm Chemotherapy arm
    Number of subjects analysed
    0 [11]
    0 [12]
    Units: months
        median (confidence interval 90%)
    ( to )
    ( to )
    Notes
    [11] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped
    [12] - DMC recommendation at IA was to stop study for futility so collection of efficacy data was stopped.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Chemotherapy
    Reporting group description
    		 Chemotherapy

    Reporting group title
    AUY922
    Reporting group description
    		 AUY922

    Serious adverse events
    		 Chemotherapy AUY922
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 23 (26.09%)
    10 / 29 (34.48%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    METASTASES TO CENTRAL NERVOUS SYSTEM
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPILEPSY
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 29 (3.45%)
         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
    ASTHENIA
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DISCOMFORT
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUDDEN DEATH
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Eye disorders
    RETINAL DEGENERATION
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VISION BLURRED
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STOMATITIS
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    HAEMOPTYSIS
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    LOCALISED INFECTION
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Chemotherapy AUY922
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 23 (91.30%)
    28 / 29 (96.55%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    0 / 23 (0.00%)
    5 / 29 (17.24%)
         occurrences all number
    0
    6
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    8 / 23 (34.78%)
    8 / 29 (27.59%)
         occurrences all number
    9
    9
    AXILLARY PAIN
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    FATIGUE
         subjects affected / exposed
    5 / 23 (21.74%)
    10 / 29 (34.48%)
         occurrences all number
    7
    14
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    OEDEMA PERIPHERAL
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 29 (3.45%)
         occurrences all number
    4
    1
    PYREXIA
         subjects affected / exposed
    4 / 23 (17.39%)
    2 / 29 (6.90%)
         occurrences all number
    4
    2
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    2 / 23 (8.70%)
    7 / 29 (24.14%)
         occurrences all number
    3
    7
    DYSPNOEA
         subjects affected / exposed
    7 / 23 (30.43%)
    2 / 29 (6.90%)
         occurrences all number
    8
    2
    HAEMOPTYSIS
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    DEPRESSION
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    INSOMNIA
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    4
    Investigations
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    3
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    HEADACHE
         subjects affected / exposed
    0 / 23 (0.00%)
    9 / 29 (31.03%)
         occurrences all number
    0
    16
    PARAESTHESIA
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    PERIPHERAL SENSORY NEUROPATHY
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    VISUAL FIELD DEFECT
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    VISUAL PERSEVERATION
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    0 / 23 (0.00%)
    5 / 29 (17.24%)
         occurrences all number
    0
    6
    LYMPHOPENIA
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    NEUTROPENIA
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 29 (0.00%)
         occurrences all number
    7
    0
    Eye disorders
    ACCOMMODATION DISORDER
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    NIGHT BLINDNESS
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    3
    PHOTOPSIA
         subjects affected / exposed
    0 / 23 (0.00%)
    10 / 29 (34.48%)
         occurrences all number
    0
    11
    VISION BLURRED
         subjects affected / exposed
    0 / 23 (0.00%)
    6 / 29 (20.69%)
         occurrences all number
    0
    7
    VISUAL ACUITY REDUCED
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    VISUAL IMPAIRMENT
         subjects affected / exposed
    0 / 23 (0.00%)
    6 / 29 (20.69%)
         occurrences all number
    0
    8
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    CONSTIPATION
         subjects affected / exposed
    2 / 23 (8.70%)
    6 / 29 (20.69%)
         occurrences all number
    4
    6
    DIARRHOEA
         subjects affected / exposed
    1 / 23 (4.35%)
    21 / 29 (72.41%)
         occurrences all number
    1
    44
    DRY MOUTH
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    NAUSEA
         subjects affected / exposed
    3 / 23 (13.04%)
    10 / 29 (34.48%)
         occurrences all number
    6
    15
    STOMATITIS
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 29 (3.45%)
         occurrences all number
    4
    1
    VOMITING
         subjects affected / exposed
    3 / 23 (13.04%)
    3 / 29 (10.34%)
         occurrences all number
    6
    4
    Hepatobiliary disorders
    HEPATOCELLULAR INJURY
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    ALOPECIA
         subjects affected / exposed
    6 / 23 (26.09%)
    0 / 29 (0.00%)
         occurrences all number
    6
    0
    NAIL DISORDER
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    PRURITUS
         subjects affected / exposed
    2 / 23 (8.70%)
    6 / 29 (20.69%)
         occurrences all number
    2
    10
    RASH
         subjects affected / exposed
    4 / 23 (17.39%)
    2 / 29 (6.90%)
         occurrences all number
    4
    2
    Renal and urinary disorders
    POLLAKIURIA
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    0 / 23 (0.00%)
    6 / 29 (20.69%)
         occurrences all number
    0
    6
    BACK PAIN
         subjects affected / exposed
    3 / 23 (13.04%)
    5 / 29 (17.24%)
         occurrences all number
    3
    6
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    0 / 23 (0.00%)
    5 / 29 (17.24%)
         occurrences all number
    0
    5
    MYALGIA
         subjects affected / exposed
    3 / 23 (13.04%)
    4 / 29 (13.79%)
         occurrences all number
    9
    5
    PAIN IN EXTREMITY
         subjects affected / exposed
    2 / 23 (8.70%)
    3 / 29 (10.34%)
         occurrences all number
    3
    3
    Infections and infestations
    CONJUNCTIVITIS
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    RHINITIS
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    3
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 23 (4.35%)
    3 / 29 (10.34%)
         occurrences all number
    1
    4
    URINARY TRACT INFECTION
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    3 / 23 (13.04%)
    4 / 29 (13.79%)
         occurrences all number
    4
    7
    HYPERGLYCAEMIA
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Feb 2013
    The primary purpose of this amendment was to implement an interim analysis for futility, in order to stop the study earlier in the event that the efficacy of the AUY922 arm was unlikely to be better than that of the chemotherapy comparator arm.
    03 Mar 2014
    A planned interim analysis was conducted per the protocol on May 23, 2014, and the DMC recommendation based on the IA results was to terminate the study due to futility. There were no new safety concerns from the data. Following the DMC recommendations, enrollment was stopped on 05 Jun 2014. In addition, patients will no longer be followed-up for survival. The study continued to offer study medication (AUY and Pemetrexed) and perform safety follow-up for the 6 patients remaining in the trial, whom the investigator deemed were benefiting from the treatment.
    03 Nov 2014
    This amendment was a global amendment. The main purpose of this amendment was to change the fresh baseline tumor biopsy from mandatory to optional for patients because this requirement appeared to impact the ability for patients to join the study.

    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.
    IA futility criterion was met based on estimated IA PFS HR = 0.76 (90% CI: 0.35, 1.63) & posterior predictive probability P (HRfinal ≤ 0.7 | HRinterim) = 0.421, below predefined threshold of a posterior predictive probability >85% to continue study
    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-Wed May 08 00:14:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA