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:
    A randomized, multicenter, open-label, phase II study of the optimal scheme of administration of pazopanib in thyroid carcinoma

    Summary
    EudraCT number
    		 2012-003162-41
    Trial protocol
    		 FR  
    Global end of trial date
    10 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Mar 2021
    First version publication date
    25 Mar 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ET12-058
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01813136
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Léon Bérard
    Sponsor organisation address
    28 rue Laennec, LYON, France, 69008
    Public contact
    Dr C. de la FOUCHARDIERE, Centre Léon Bérard, +33 4 78 78 28 28, DRCIreglementaire@lyon.unicancer.fr
    Scientific contact
    Dr C. de la FOUCHARDIERE, Centre Léon Bérard, +33 4 78 28 28, DRCIreglementaire@lyon.unicancer.fr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to compare the time to treatment failure in patients with continuous pazopanib versus intermittent pazopanib treatment
    Protection of trial subjects
    Information of patient and informed consent signature will be performed prior to any study-specific procedure. The patient will be orally provided by the investigator with the appropriate information; in addition, he will be given written information and an informed consent form. After a sufficient time to think, the patient will give his written consent, by dating and signing the inform consent form. This form will also be signed and dated by the investigator, preferentially on the same day, and a copy will be given to the patient (the original form will be archived in the patient medical file). All screening examinations will be performed within 15 days prior to first pazopanib administration (day 1). With these exams, the investigational staff will be able to confirm the patient’s eligibility, to assess the extent of disease and determine the baseline signs and symptoms. If all the selection criteria are fulfilled, the investigator will proceed to the inclusion registration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jun 2013
    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: 168
    Worldwide total number of subjects
    168
    EEA total number of subjects
    168
    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)
    167
    From 65 to 84 years
    0
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All screening examinations will be performed within 15 days prior to first pazopanib administration (day 1). With these exams, the investigational staff will be able to confirm the patient’s eligibility, to assess the extent of disease and determine the baseline signs and symptoms. If all the selection criteria are fulfilled, the investigator will

    Period 1
    Period 1 title
    Treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Pazopanib
    Arm description
    		 First, all patients included in the study will be treated with pazopanib at the dose of 800 mg daily for 6 cycles.
    Arm type
    		 Pazopanib for all included patient

    Investigational medicinal product name
    PAZOPANIB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    All patients included in the study will be treated with pazopanib at the dose of 800 mg daily for 6 cycles.

    Number of subjects in period 1
    		Pazopanib
    Started
    168
    Completed
    100
    Not completed
    68
         Early toxicity
    20
         Early progressive disease
    34
         Death
    3
         Other reasons
    11
    Period 2
    Period 2 title
    Randomisation
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A = Reference strategy
    Arm description
    		 Continuation of oral administration of pazopanib at the dose of 800 mg daily, until disease progression or unacceptable toxicity.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PAZOPANIB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    Continuation of oral administration of pazopanib at the dose of 800 mg daily, until disease progression or unacceptable toxicity.

    Arm title
    		 Arm B = Experimental strategy
    Arm description
    		 Temporary discontinuation of pazopanib until a first off-treatment progression. As soon as this progression occurs, daily oral administration of 800 mg pazopanib will be reintroduced for six additional cycles. If an on-treatment progression occurs before the end of the 6th cycle, pazopanib will be permanently discontinued. However, in case of long term stability or response, patient will remain in the study and will be treated with intermittent 6-cycle periods until on-treatment progression or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PAZOPANIB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    Temporary discontinuation of pazopanib until a first off-treatment progression. As soon as this progression occurs, daily oral administration of 800 mg pazopanib will be reintroduced for six additional cycles. If an on-treatment progression occurs before the end of the 6th cycle, pazopanib will be permanently discontinued. However, in case of long term stability or response, patient will remain in the study and will be treated with intermittent 6-cycle periods until on-treatment progression or unacceptable toxicity.

    Number of subjects in period 2
    		Arm A = Reference strategy Arm B = Experimental strategy
    Started
    50
    50
    Completed
    50
    50

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Pazopanib
    Reporting group description
    		 First, all patients included in the study will be treated with pazopanib at the dose of 800 mg daily for 6 cycles.
    Reporting group title
    Arm A = Reference strategy
    Reporting group description
    		 Continuation of oral administration of pazopanib at the dose of 800 mg daily, until disease progression or unacceptable toxicity.

    Reporting group title
    Arm B = Experimental strategy
    Reporting group description
    		 Temporary discontinuation of pazopanib until a first off-treatment progression. As soon as this progression occurs, daily oral administration of 800 mg pazopanib will be reintroduced for six additional cycles. If an on-treatment progression occurs before the end of the 6th cycle, pazopanib will be permanently discontinued. However, in case of long term stability or response, patient will remain in the study and will be treated with intermittent 6-cycle periods until on-treatment progression or unacceptable toxicity.

    Primary: Primary end point

    		 Close Top of page
    End point title
    		 Primary end point [1]
    End point description
    End point type
    Primary
    End point timeframe
    Time to permanent treatment discontinuation due to any cause after randomization in each arm
    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: Efficacy analysis (including response rate) will be conducted using the intention-to-treat principle (ITT). All patients will be taken in the calculation. Safety analysis will be performed on all included patients who received at least one dose of study treatment. Primary endpoint will be evaluated using Kaplan-Meier method. Time to treatment failure curves will be compared between arms using a log-rank test. Median survival will be presented in each arm with its 95% Confidence Interval.
    End point values
    		 Arm A = Reference strategy Arm B = Experimental strategy
    Number of subjects analysed
    50
    50
    Units: Time to Treatment Failure
    50
    50
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    The investigator collects (spontaneous patient report or questionning) and immediately notifies the sponsor of all SAEs, in a written report, wether or not theay are deemed to be attributable to research and wich occur during the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Prior to randomization, 163 patients had at least one treatment-related adverse event, 121 patients had at least one grade ≥3 AE and 91 patients had at least one related grade ≥3 AE. After randomization, 96.0% of patients presented at least one related AE. Grade ≥3 AEs were reported for 61% of patients. 36.0% of patients presented at least one related AE of grade ≥3. SAE were reported for 43.0% of patients and related SAEs for 21.0% of patients.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Aug 2013
    Modify 2 inclusion criteria Add a liver test during cycle 2 (D15) following the publication of the new BI (v10 of 02/22/2013)
    17 Feb 2014
    Modification of the inclusion criterion I2: confirmation of the diagnosis by a regional referent made non-compulsory PET performance becomes optional on inclusion and before randomization Participation in the ancillary study made optional
    24 Jul 2015
    Remove inclusion criterion I3 Annual update of the pazopanib investigator brochure (v12 of 12/17/2014) having an impact on patient safety Extend the recruitment period by 24 months and consequently the duration of the study (without modification of the follow-up
    12 Aug 2016
    Annual update of the pazopanib investigator brochure having an impact on patient safety
    08 Nov 2017
    Update of the pazopanib investigator brochure (Votrient Ed 15 of 10/11/2016) having an impact on the reference information on safety and the protocol (without impact on the benefit / risk balance) Update of the vigilance rules following Decree 2016-1537 of November 16, 2016 relating to research involving humans Extension of the inclusion period by 18 months and consequently of the duration of the study (without modification of the follow-up)

    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
    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-Mon Apr 29 12:07:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA