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Clinical trials for 2014-002123-10

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

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

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

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    1 result(s) found for: 2014-002123-10. Displaying page 1 of 1.
    EudraCT Number: 2014-002123-10 Sponsor Protocol Number: 1200.120 Start Date*: 2015-04-18
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: Phase I open label, dose escalation trial to determine the MTD, safety, PK and efficacy of afatinib monotherapy in children aged 2 years to <18 years with recurrent/refractory neuroectodermal tumou...
    Medical condition: Paediatric patients with recurrent//refractory high grade glioma (HGG), diffuse intrinsic pontine glioma (DIPG), low grade astrocytoma, neuroblastoma, ependymoma, medulloblastoma/primitive neuroect...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10029091 Neoplasm of unspecified nature of endocrine glands and other parts of nervous system LLT
    18.0 100000004864 10029006 Neoplasm of uncertain behavior of brain and spinal cord LLT
    18.0 100000004864 10029050 Neoplasm of uncertain behaviour of connective and other soft tissue LLT
    18.0 100000004864 10028992 Neoplasm CNS LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Temporarily Halted) DE (Completed) GB (GB - no longer in EU/EEA) AT (Completed) FR (Completed) DK (Completed) IT (Completed) NL (Completed) IE (Completed)
    Trial results: View results
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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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