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Clinical trials for NTRK gene fusions

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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    5 result(s) found for: NTRK gene fusions. Displaying page 1 of 1.
    EudraCT Number: 2017-004246-20 Sponsor Protocol Number: 20810 Start Date*: 2018-03-06
    Sponsor Name:Bayer Consumer Care AG
    Full Title: A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers Formerly: A Phase 1/2 Study of the TRK Inhibitor LOXO-1...
    Medical condition: NTRK fusion cancers previously treated with a TRK inhibitor
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10049516 Malignant tumor LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007958 Central nervous system neoplasm PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) FR (Completed) DE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) IE (Completed) IT (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-003582-28 Sponsor Protocol Number: LOXO-TRK-15002 Start Date*: Information not available in EudraCT
    Sponsor Name:Bayer Consumer Care AG
    Full Title: A Phase 2 Basket Study of the Oral TRK Inhibitor larotrectinib in Subjects with NTRK Fusion-Positive Tumors
    Medical condition: Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Trial now transitioned) IE (Completed) ES (Trial now transitioned) PT (Trial now transitioned) FR (Trial now transitioned) DE (Trial now transitioned) SE (Trial now transitioned) BE (Completed) CZ (Completed) SK (Completed) NO (Completed) HU (Completed) PL (Completed) GR (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-003498-16 Sponsor Protocol Number: LOXO-TRK-15003 Start Date*: 2017-02-10
    Sponsor Name:Loxo Oncology Inc.
    Full Title: A Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients with Advanced Solid or Primary Central Nervous System Tumors
    Medical condition: Central Nervous System Neoplasms and advanced solid tumors
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007959 Central nervous system neoplasm NOS LLT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10049516 Malignant tumor LLT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007958 Central nervous system neoplasm PT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007960 Central nervous system neoplasms malignant NEC HLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Trial now transitioned) GB (GB - no longer in EU/EEA) DE (Trial now transitioned) SE (Trial now transitioned) DK (Trial now transitioned) FR (Trial now transitioned) NL (Trial now transitioned) IE (Trial now transitioned) PL (Completed) IT (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001155-39 Sponsor Protocol Number: CO40778 Start Date*: 2019-11-22
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE 1/2, OPEN-LABEL, DOSE-ESCALATION AND EXPANSION STUDY OF ENTRECTINIB (RXDX-101) IN PEDIATRICS WITH LOCALLY ADVANCED OR METASTATIC SOLID OR PRIMARY CNS TUMORS AND/OR WHO HAVE NO SATISFACTORY ...
    Medical condition: Solid tumors and primary central nervous system (CNS) tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002770-27 Sponsor Protocol Number: DRA-104-001 Start Date*: 2021-07-12
    Sponsor Name:Dracen Pharmaceuticals, Inc.
    Full Title: Phase 1 and phase 2a, first-in-human study of DRP-104, a glutamine antagonist, in adult patients with advanced solid tumors
    Medical condition: Cancer, advanced solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing)
    Trial results: (No results available)
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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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