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    Clinical Trial Results:
    An Open-Label, Multicenter Extension Study of Onartuzumab in Patients with Solid Tumors on Study Treatment Previously Enrolled in an F. Hoffmann-La Roche and/or Genentech Sponsored Study

    Summary
    EudraCT number
    		 2014-005438-69
    Trial protocol
    		 ES   LV   IT  
    Global end of trial date
    29 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jul 2019
    First version publication date
    10 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GO29646
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02488330
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jun 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives of this trial were: To provide continued onartuzumab and/or parent trial (P-trial)-designated control treatments to subjects with cancer previously enrolled in a Roche/Genentech P-trial; and to collect safety data related to the administration of continued onartuzumab therapy.
    Protection of trial subjects
    All subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Aug 2015
    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
    Japan: 1
    Country: Number of subjects enrolled
    Latvia: 2
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    South Africa: 2
    Country: Number of subjects enrolled
    Serbia: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Russian Federation: 1
    Worldwide total number of subjects
    12
    EEA total number of subjects
    7
    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)
    8
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 10 centers in Japan, Latvia, Italy, South Africa, Serbia, Spain, France, and the Russian Federation.

    Pre-assignment
    Screening details
    		 Participants with solid tumors previously enrolled in an F. Hoffmann-La Roche and/or Genentech parent trial (P-trial) who received either the control treatment or onartuzumab-based study treatment, had not met the treatment discontinuation criteria for their P-trial, and were able to start treatment within 42 days of the last day of their P-trial.

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

    Arms
    Arm title
    		 Control and/or Onartuzumab treatment
    Arm description
    		 Participants received treatment with either the control treatment (erlotinib, bevacizumab) and/or ornartuzumab-based study treatment until disease progression, unacceptable treatment-related toxicity, withdrawal of consent, or death (whichever occurred first).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Onartuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Onartuzumab was administered intravenously (IV) at a dose of either 10 mg/kg every 2 weeks, or 15 mg/kg every 3 weeks.

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received IV bevacizumab at a dose based on the manufacturer's prescribing information.

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Tarceva
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received oral erlotinib at a dose based on the manufacturers prescribing information.

    Number of subjects in period 1
    		Control and/or Onartuzumab treatment
    Started
    12
    Completed
    0
    Not completed
    12
         Adverse event, serious fatal
    2
         Physician decision
    2
         Adverse event, non-fatal
    1
         Study Termination by Sponsor
    4
         Disease Progression
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control and/or Onartuzumab treatment
    Reporting group description
    		 Participants received treatment with either the control treatment (erlotinib, bevacizumab) and/or ornartuzumab-based study treatment until disease progression, unacceptable treatment-related toxicity, withdrawal of consent, or death (whichever occurred first).

    Reporting group values
    		 Control and/or Onartuzumab treatment Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 4 4
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 59.67 ± 9.78 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 6 6
        Male
    		 6 6
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 1 1
        White
    		 9 9
        Unknown or Not Reported
    		 2 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 12 12
        Unknown or Not Reported
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Control and/or Onartuzumab treatment
    Reporting group description
    		 Participants received treatment with either the control treatment (erlotinib, bevacizumab) and/or ornartuzumab-based study treatment until disease progression, unacceptable treatment-related toxicity, withdrawal of consent, or death (whichever occurred first).

    Primary: Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab

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    End point title
    		 Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab [1]
    End point description
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
    End point type
    Primary
    End point timeframe
    Baseline through the end of trial (approximately 3 years)
    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: No formal statistical analysis was planned for this study.
    End point values
    		 Control and/or Onartuzumab treatment
    Number of subjects analysed
    12
    Units: Percent
        number (not applicable)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Baseline through the end of trial (approximately 3 years)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Control and/or Onartuzumab treatment
    Reporting group description
    		 Participants received treatment with either the control treatment (erlotinib, bevacizumab) and/or ornartuzumab-based study treatment until disease progression, unacceptable treatment-related toxicity, withdrawal of consent, or death (whichever occurred first).

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The protocol states that only serious adverse events will be collected.
    Serious adverse events
    		 Control and/or Onartuzumab treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 12 (41.67%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Cyanosis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Sudden cardiac death
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory failure
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control and/or Onartuzumab treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Sep 2015
    Clarification of study treatment dose calculation; update to I/E criteria
    17 Aug 2017
    Classification of bevacizumab and erlotinib as control treatment for 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.
    None reported
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    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.

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