Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Neurofibromas

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   44335   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.
    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
     
    15 result(s) found for: Neurofibromas. Displaying page 1 of 1.
    EudraCT Number: 2010-019759-23 Sponsor Protocol Number: PET-CT140410 Start Date*: 2011-01-12
    Sponsor Name:Guys' and St. Thomas' NHS Foundation Trust
    Full Title: Evaluation of [11C]-methionine positron emission computerised tomography (PET CT) in diagnosing neurofibromatosis 1(NF1) - malignant peripheral nerve sheath tumours (MPNST)
    Medical condition: The diagnosis of malignant peripheral nerve sheath tumours in patients with neurofibromatosis 1
    Disease: Version SOC Term Classification Code Term Level
    12 10029268 Neurofibromatosis 1 associated malignant peripheral nerve sheath tumour LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001317-16 Sponsor Protocol Number: TRAIN_2019 Start Date*: 2019-10-30
    Sponsor Name:ErasmusMC
    Full Title: The TRAIN study: TRAmetinib In Neurofibromatosis type 1 related symptomatic plexiform neurofibromas
    Medical condition: Adult patients (age >17 years) with (mosaic) NF1 with inoperable symptomatic plexiform neurofibromas
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029267 Neurofibroma PT
    20.0 100000004850 10029270 Neurofibromatosis, type 1 (von Recklinghausen's disease) LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-000869-21 Sponsor Protocol Number: Ima-NF1-2012 Start Date*: 2012-04-12
    Sponsor Name:ISTITUTO NEUROLOGICO "CARLO BESTA"
    Full Title: Pilot study: Imatinib for the treatment of plexiform neurofibromas in NF1 patients.
    Medical condition: Patients with NF1 and plessiform neurofibromas
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-001563-36 Sponsor Protocol Number: CRAD001MIL04T Start Date*: 2016-05-12
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A Phase II Study of RAD001 in the Treatment of Patients With Plexiform Neurofibromas (PN) Associated With Neurofibromatosis Type 1 (NF1)
    Medical condition: Plexiform Neurofibroma Associated With Neurofibromatosis Type 1
    Disease:
    Population Age: Children, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-002228-42 Sponsor Protocol Number: P101202 Start Date*: Information not available in EudraCT
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10029268 Neurofibromatosis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005607-39 Sponsor Protocol Number: D134BC00001 Start Date*: 2021-10-05
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Multicentre, International Study with a Parallel, Randomised, Double blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants with...
    Medical condition: Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10029270 Neurofibromatosis, type 1 (von Recklinghausen's disease) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Restarted) PL (Trial now transitioned) IT (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005648-52 Sponsor Protocol Number: D1346C00015 Start Date*: 2021-05-31
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase I, Single-Arm, Sequential Study to Evaluate the Effect of Food on the Gastrointestinal Tolerability and Pharmacokinetics of Selumetinib after Multiple Doses in Adolescent Children with Neur...
    Medical condition: Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029270 Neurofibromatosis, type 1 (von Recklinghausen's disease) LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005608-20 Sponsor Protocol Number: D1346C00004 Start Date*: 2021-11-24
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥ 1 to < 7 Years with Neurofibr...
    Medical condition: Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029270 Neurofibromatosis, type 1 (von Recklinghausen's disease) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) NL (Prematurely Ended) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001846-32 Sponsor Protocol Number: BUS2018-1 Start Date*: 2018-09-18
    Sponsor Name:VO Barnmedicin, Skånes University Hospital
    Full Title: Treatment of NF1-related plexiform neurofibroma with trametinib; a single arm, open-label trial with the goals of volumetric partial remission and pain relief
    Medical condition: NF1-related plexiform neurofibroma
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016922-15 Sponsor Protocol Number: HSJD-IMANF1 Start Date*: 2010-02-04
    Sponsor Name:HOSPITAL SANT JOAN DE DÉU
    Full Title: ENSAYO PILOTO CON IMATINIB PARA PACIENTES CON NEUROFIBROMA PLEXIFORME ASOCIADO A LA NEUROFIBROMATOSIS TIPO I. PILOT STUDY WITH IMATINIB FOR PLEXIFORM NEUROFIBROMA IN NEUROFIBROMATOSIS TYPE I PATIENTS
    Medical condition: Tratamiento de los neurofibromas plexiformes de alto riesgo no abordables quirúrgicamente en pacientes con neurofibromatosis tipo I
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    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: 2016-005022-10 Sponsor Protocol Number: SYN-1748-MAL-0030-I Start Date*: 2018-02-13
    Sponsor Name:Technische Universität München, Fakultät für Medizin
    Full Title: Improvement of synaptic plasticity and cognitive function in RAS pathway disorders
    Medical condition: Noonan Syndrom and Neurofibromatosis Type 1
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029748 Noonan syndrome PT
    20.0 10010331 - Congenital, familial and genetic disorders 10029268 Neurofibromatosis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    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)
    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: 2013-003596-35 Sponsor Protocol Number: MEK116540 Start Date*: 2015-12-15
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescents Subj...
    Medical condition: Children and Adolescents with Cancers Harboring V600 mutations
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    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-Sat May 10 00:40:37 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA