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Clinical trials for Brigatinib

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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    15 result(s) found for: Brigatinib. Displaying page 1 of 1.
    EudraCT Number: 2019-002369-36 Sponsor Protocol Number: GECP19/01 Start Date*: 2020-04-18
    Sponsor Name:Fundación GECP
    Full Title: Clinical Utility of Liquid Biopsy as a tool to assess the evolution of brigatinib treated patients with non-small cell lung cancer with EML4-ALK translocation: an exploratory study
    Medical condition: ALK+ non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10025055 Lung cancer non-small cell stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003447-19 Sponsor Protocol Number: AP26113-13-301 Start Date*: 2016-06-13
    Sponsor Name:ARIAD Pharmaceuticals, Inc. (a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited)
    Full Title: A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) versus Crizotinib in Patients with ALK-positive Advanced Lung Cancer
    Medical condition: ALK positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Completed) DE (Completed) NL (Completed) FI (Completed) SE (Completed) NO (Completed) DK (Completed) ES (Completed) CZ (Prematurely Ended) PT (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002713-34 Sponsor Protocol Number: ITCC-098 Start Date*: 2021-12-30
    Sponsor Name:Princess Maxima Center for Pediatric Oncology in The Netherlands
    Full Title: A Phase I/II study of Brigatinib in pediatric and young adult patients with ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or other solid tumors
    Medical condition: relapsed/refractory ALK rearranged** or ALK mutated tumors, including relapsed/refractory ALK+ALCL and ALK+IMT.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) DK (Trial now transitioned) SE (Trial now transitioned) IT (Trial now transitioned) DE (Trial now transitioned) NO (Prematurely Ended) BE (Trial now transitioned) FI (Trial now transitioned) PL (Trial now transitioned) AT (Ongoing) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001957-29 Sponsor Protocol Number: Brigatinib-3001 Start Date*: 2018-12-13
    Sponsor Name:ARIAD Pharmaceuticals, Inc.(a wholly-owned subsidiary of Takeda Pharmaceutical Ltd.)
    Full Title: A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIGTM) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive on–Small-Cell Lung Cancer Patients Who Have Progresse...
    Medical condition: ALK positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) SE (Completed) ES (Prematurely Ended) DE (Prematurely Ended) AT (Completed) GR (Prematurely Ended) HR (Completed) IT (Prematurely Ended) RO (Completed)
    Trial results: View results
    EudraCT Number: 2018-000635-27 Sponsor Protocol Number: 2002 Start Date*: 2018-10-10
    Sponsor Name:ARIAD Pharmaceuticals, Inc.(a wholly-owned subsidiary of Takeda Pharmaceutical Ltd.)
    Full Title: Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non–Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
    Medical condition: Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non–Small-Cell Lung Cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) ES (Completed) AT (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002567-22 Sponsor Protocol Number: IFCT-2101 Start Date*: 2022-01-10
    Sponsor Name:IFCT
    Full Title: A phase II randomized, open-labelled, multicenter study of safety and efficacy of combination brigatinib and carboplatin-pemetrexed therapy or brigatinib monotherapy as first-line treatment in pati...
    Medical condition: Advanced ALK-positive non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-002134-21 Sponsor Protocol Number: AP26113-13-201 Start Date*: 2014-07-22
    Sponsor Name:ARIAD Pharmaceuticals, Inc. (a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited)
    Full Title: A Randomized Phase 2 Study of AP26113 in Patients with ALK-positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated with Crizotinib
    Medical condition: Patients with ALK-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) IT (Completed) NL (Completed) DK (Completed) AT (Completed) BE (Completed) SE (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2019-004070-26 Sponsor Protocol Number: BRICE Start Date*: 2021-08-02
    Sponsor Name:FONDAZIONE RICERCA TRASLAZIONALE (FORT)
    Full Title: A Phase 1/2 Study Exploring Safety, Tolerability and Efficacy of BRIgatinib in Combination With CEtuximab in Subjects With Advanced EGFR mutated or ALK or ROS1 positive Non-Small Cell Lung Cancer a...
    Medical condition: Advanced or metastatic epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC) with acquired resistance to approved EGFR tyrosine kinase inhibitors (TKI); advan...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001828-36 Sponsor Protocol Number: ABP-2019 Start Date*: 2020-02-21
    Sponsor Name:Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
    Full Title: Advancing Brigatinib Properties in anaplastic lymphoma kinase positive non-small cell lung cancer (ALK+ NSCLC) patients by deep phenotyping
    Medical condition: Anaplastic lymphoma kinase positive non-small cell lung cancer (ALK+ NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002230-37 Sponsor Protocol Number: IFCT-1902 Start Date*: 2019-09-16
    Sponsor Name:IFCT
    Full Title: A phase II non-randomized, single group assignment, open-label, multicenter study of efficacy and safety of lORlatinib (PF-06463922) monotherapy after failure of first-line second-generation ALK ki...
    Medical condition: advanced ALK-positive non-small cell Lung cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-000122-21 Sponsor Protocol Number: NVL-655-01 Start Date*: 2022-07-08
    Sponsor Name:Nuvalent, Inc.
    Full Title: A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
    Medical condition: Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors with ALK rearrangement or activating ALK mutation.
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-002190-21 Sponsor Protocol Number: MAR-BAS-18-005 Start Date*: 2020-07-08
    Sponsor Name:Fondazione per la Medicina Personalizzata
    Full Title: The ROME trial from histology to target: the road to personalize target therapy and immunotherapy
    Medical condition: Patients with progressive disease (recurrent and/or metastatic) of breast cancer, metastatic gastro-intestinal tumors, non small cell lung cancer (NSCLC) or others. Patients should have completed a...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066275 Comedocarcinoma of breast LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007351 Carcinoma gastrointestinal LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10071533 Lung squamous cell carcinoma metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003954-26 Sponsor Protocol Number: STAR22 Start Date*: 2019-01-30
    Sponsor Name:Erasmus MC Cancer Institute
    Full Title: CYP3A4*22 genotype-guided dosing of TKIs in cancer patients: a new way of personalized therapy
    Medical condition: Patients diagnosed with a neoplasm and treated with a tyrosine kinase inhibitor which is mainly metabolised by CYP3A4.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003616-13 Sponsor Protocol Number: TPX-0005-01 Start Date*: 2020-05-12
    Sponsor Name:Turning Point Therapeutics, Inc.
    Full Title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ...
    Medical condition: advanced solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) DE (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) HU (Trial now transitioned) DK (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003862-41 Sponsor Protocol Number: EORTC1825LCG Start Date*: 2020-06-30
    Sponsor Name:European Organisation for Research and Treatment of Cancer
    Full Title: Activity of Lorlatinib based on ALK resistance mutations on blood in ALK positive NSCLC patients previously treated with 2nd generation ALK inhibitor
    Medical condition: Non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) NL (Completed) FR (Completed) IT (Prematurely Ended) ES (Completed)
    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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