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Clinical trials for 2010-018501-10

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    2 result(s) found for: 2010-018501-10. Displaying page 1 of 1.
    EudraCT Number: 2010-018501-10 Sponsor Protocol Number: BAY43-9006/12444 Start Date*: 2011-03-23
    Sponsor Name:Bayer HealthCare AG
    Full Title: A Phase III Randomized, Double blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negativ...
    Medical condition: Locally advanced or metastatic HER2-negative breast cancer.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10004244 Benign breast neoplasm NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) GB (Completed) AT (Completed) CZ (Completed) IE (Completed) ES (Completed) HU (Completed) IT (Completed) GR (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002053-29 Sponsor Protocol Number: 03042012 Start Date*: 2012-08-10
    Sponsor Name:Karolinska Institutet and University Hospital
    Full Title: PET/CT-biopsi study A PET/CT biopsy sub study in patients who have given informed consent to participate in a randomized, dubbel blind, placebo controlled phase III trial with Capecitabine +/- So...
    Medical condition: Morphological verifications of metastatic lesions, PET Ribonucleic Acid (RNA)-expression study in subjects with locally advance or metastatic HER2-negative breast cancer.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004244 Benign breast neoplasm NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
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    Query did not match any studies.
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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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