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Clinical trials for Ceritinib

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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    17 result(s) found for: Ceritinib. Displaying page 1 of 1.
    EudraCT Number: 2015-000814-23 Sponsor Protocol Number: CLDK378A2407 Start Date*: 2015-10-26
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A Phase II, open label, multi-center, multi-arm study of ceritinib in patients with advanced solid tumors and hematological malignancies characterized by genetic abnormalities of anaplastic lymphom...
    Medical condition: Advanced solid tumors and hematological malignancies with ALK genetic alteration and/or overexpression
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Temporarily Halted) CZ (Completed) FR (Prematurely Ended) DK (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-003032-39 Sponsor Protocol Number: CLEE011X2110C Start Date*: 2014-12-26
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive Non-small Cell Lung Cancer
    Medical condition: Non-Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    17.0 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: ES (Completed) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-001922-40 Sponsor Protocol Number: CLDK378A2X01B Start Date*: 2016-01-04
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the invest...
    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: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Completed) BE (Trial now transitioned) FR (Trial now transitioned) BG (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-000578-20 Sponsor Protocol Number: CLDK378A2205 Start Date*: 2015-03-16
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A phase II, multi-center, open-label, five-arm study to evaluate the efficacy and safety of oral ceritinib treatment for patients with ALK-Positive Non-Small Cell Lung Cancer (NSCLC) metastatic to ...
    Medical condition: Non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024233 Leptomeningeal metastases LLT
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006128 Brain metastases LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed) GB (Completed) DE (Completed) NL (Completed) BE (Completed) IT (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: (No results available)
    EudraCT Number: 2019-002504-41 Sponsor Protocol Number: B7461027 Start Date*: 2020-07-17
    Sponsor Name:Pfizer Inc.
    Full Title: Single-Arm Study of Lorlatinib in Participants with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) Whose Disease Progressed After One Prior Second-Generation ALK Tyros...
    Medical condition: ALK-positive 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) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) GB (GB - no longer in EU/EEA) IT (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: 2012-002074-31 Sponsor Protocol Number: CLDK378X2103 Start Date*: 2013-11-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase I, open-label, dose escalation study of LDK378 in pediatric patients with malignancies that have a genetic alteration in anaplastic lymphoma kinase (ALK)
    Medical condition: malignancies characterized by genetic abnormalities in anaplastic lymphoma kinase (ALK)
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) GB (Completed) IT (Completed) FR (Completed) ES (Completed)
    Trial results: View results
    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: 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: 2019-000727-41 Sponsor Protocol Number: GFPC062018 Start Date*: 2019-06-04
    Sponsor Name:Centre François Baclesse
    Full Title: A multicentre phase II, open-label, non-randomized study evaluating Platinum-Pemetrexed-Atezolizumab ( Bevacizumab) for patients with stage IIIB/IV non-squamous non-small cell lung cancer with EGF...
    Medical condition: Patients with stage IIIB/IV non-squamous non-small cell lung cancer with EGFR mutations, ALK rearrangement or ROS1 fusion progressing after targeted therapies
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029515 Non-small cell lung cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002851-27 Sponsor Protocol Number: C16-40 Start Date*: 2018-10-08
    Sponsor Name:INSERM
    Full Title: MOLECULAR PROFILING OF ADVANCED SOFT-TISSUE SARCOMAS - A phase III study
    Medical condition: Adult patients with locally advanced/unresectable and/or metastatic soft-tissue sarcoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10039494 Sarcoma NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (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)
    EudraCT Number: 2019-003296-19 Sponsor Protocol Number: AFM24-101 Start Date*: 2020-03-27
    Sponsor Name:Affimed GmbH
    Full Title: A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients with Advanced Solid Cancers
    Medical condition: Advanced solid malignancies in patients whose disease has progressed after treatment with previous anticancer therapies.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-005637-36 Sponsor Protocol Number: CLDK378A2303 Start Date*: 2013-09-30
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase III, multicenter, randomized, open-label study of oral LDK378 versus standard chemotherapy in adult patients with ALK-rearranged (ALK-positive) advanced non-small cell lung cancer who have ...
    Medical condition: 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) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Ongoing) FR (Completed) NL (Completed) GB (GB - no longer in EU/EEA) IE (Completed) BE (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000319-26 Sponsor Protocol Number: CLDK378A2301 Start Date*: 2013-08-14
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK-positive), stage IIIB or IV, non-squamous non-s...
    Medical condition: 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) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Prematurely Ended) IT (Completed) NL (Prematurely Ended) DE (Completed) ES (Prematurely Ended) GB (GB - no longer in EU/EEA) FR (Prematurely Ended) GR (Completed) HU (Completed) IE (Prematurely Ended) PL (Prematurely Ended) DK (Completed) NO (Prematurely Ended) PT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-001326-15 Sponsor Protocol Number: RXDX-101-01 Start Date*: 2014-10-15
    Sponsor Name:Ignyta Inc.
    Full Title: A Phase 1/2a, Multicenter, Open-Label Study of Oral RXDX-101 in Adult Patients with Locally Advanced or Metastatic Cancer Confirmed to be Positive for TrkA, TrkB, TrkC, ROS1, or ALK Molecular Alter...
    Medical condition: Locally advanced or metastatic solid tumors
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10065252 Solid tumor LLT
    17.0 100000004864 10065143 Malignant solid tumour LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
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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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