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Clinical trials for Lisch nodules

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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    3 result(s) found for: Lisch nodules. Displaying page 1 of 1.
    EudraCT Number: 2016-000847-16 Sponsor Protocol Number: D1532C00057 Start Date*: 2019-01-29
    Sponsor Name:National Cancer Institute, Cancer Therapy Evaluation Program
    Full Title: A Phase 1/2 Study of the Mitogen Activated Protein Kinase Kinase(MEK) 1 Inhibitor Selumetinib (AZD6244, ARRY-142886, Hydrogen Sulfate) in Children With Neurofibromatosis Type 1 (NF1) and Inoperable...
    Medical condition: Neurofibromatosis type 1 (NF1)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029267 Neurofibroma PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2017-002635-41 Sponsor Protocol Number: 15HI53 Start Date*: 2018-09-26
    Sponsor Name:Great Ormond Street Hospital
    Full Title: A paediatric phase I/II study of intermittent dosing of the MEK-1 inhibitor selumetinib in children with neurofibromatosis type-1 and inoperable plexiform neurofibroma and/or progressive optic path...
    Medical condition: Neurofibromatosis type 1 associated plexiform neurofibromas Neurofibromatosis type 1 associated progressive or relapsed optic pathway glioma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10029270 Neurofibromatosis, type 1 (von Recklinghausen's disease) LLT
    20.0 100000004864 10065866 Plexiform neurofibroma LLT
    20.0 100000004864 10030935 Optic nerve glioma LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-001572-42 Sponsor Protocol Number: FCN-159-002 Start Date*: 2021-12-21
    Sponsor Name:Shanghai Fosun Pharmaceutical Industrial Development Co.,Ltd.
    Full Title: A multi-center, open-label, single-arm Phase I dose-escalation and Phase II dose-expansion study to evaluate the safety, tolerability, PK characteristics and anti-tumor activity of FCN-159 in adult...
    Medical condition: Participants diagnosed with Neurofibromatosis NF1-related plexiform neurofibromas (PN) and symptomatic with requirement of systematic therapy per investigator’s judgment. A PN is defined as a neuro...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10029270 Neurofibromatosis, type 1 (von Recklinghausen's disease) LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Ongoing) PL (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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