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Clinical trials for Therapeutic Use Exemption

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    3 result(s) found for: Therapeutic Use Exemption. Displaying page 1 of 1.
    EudraCT Number: 2006-006537-40 Sponsor Protocol Number: VEG108838 Start Date*: 2008-01-22
    Sponsor Name:GlaxoSmithkline Research & Development Limited
    Full Title: A Randomized, Multicenter, Phase III Study Comparing the Combination of Pazopanib and Lapatinib versus Lapatinib Monotherapy in Patients with ErbB2 over-expressing Inflammatory Breast Cancer
    Medical condition: Relapsed or refractory inflammatory breast cancer with ErbB2 tumours.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021974 Inflammatory breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) BE (Completed) DE (Prematurely Ended) GB (Completed) FR (Completed) ES (Completed) IT (Completed) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000625-12 Sponsor Protocol Number: CTMX-M-2009-001 Start Date*: 2018-02-15
    Sponsor Name:CytomX Therapeutics, Inc
    Full Title: A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults with Metastatic or Lo...
    Medical condition: Metastatic or locally advanced unresectable solid tumors in following indications: breast cancer (BC), castrate-resistant prostate carcinoma (CRPC), non-small cell lung carcinoma (NSCLC), ovarian...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) ES (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-005912-28 Sponsor Protocol Number: EGF107671 Start Date*: 2007-04-16
    Sponsor Name:GlaxoSmithKline Research & Development Ltd.
    Full Title: Study EGF107671 – a Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radi...
    Medical condition: Brain metastases from ErbB2-positive breast cancer
    Disease: Version SOC Term Classification Code Term Level
    8.1 10006128 Brain metastases LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) ES (Completed) BE (Completed) AT (Completed) FR (Completed) GR (Completed) IT (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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