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Clinical trials for Imatinib AND Tasigna, Gleevec

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
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    • 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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    6 result(s) found for: Imatinib AND Tasigna, Gleevec. Displaying page 1 of 1.
    EudraCT Number: 2008-004758-34 Sponsor Protocol Number: CAMN107G2301 Start Date*: 2009-03-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, open-label, multi-center phase III study to evaluate the efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tu...
    Medical condition: adult patients with histologically confirmed unresectable or metastatic GIST, either who have not received any prior anti-neoplastic therapy or, who experienced recurrence of GIST > 6 months after ...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10062427 Gastrointestinal stromal tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) ES (Completed) SK (Completed) CZ (Completed) SE (Completed) HU (Completed) NL (Completed) DE (Completed) FR (Completed) IT (Completed) GB (Completed) DK (Prematurely Ended) GR (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2007-000208-34 Sponsor Protocol Number: CAMN107A2303 Start Date*: 2007-06-11
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase III multi-center, open label, randomised study of imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chr...
    Medical condition: Adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009015 Chronic myeloid leukemia LLT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009013 Chronic myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) BE (Completed) IT (Completed) ES (Completed) SK (Completed) AT (Completed) FR (Completed) NL (Completed) FI (Completed) DK (Completed) DE (Completed) PT (Prematurely Ended) HU (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-001483-51 Sponsor Protocol Number: CAMN107A2101 Start Date*: 2005-07-12
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase IA/II multicenter, dose-escalation study of oral AMN107 on a continuous daily dosing schedule in adult patients with Gleevec (imatinib)-resistant/intolerant CML in chronic or accelerated ph...
    Medical condition: CML in chronic phase, accelerated phase or blast crisis, relapsed/refractory Ph+ ALL, systemic mastocytosis, or hypereosinophilic syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009700 CML LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) GB (Completed) SE (Completed) IT (Completed) DK (Completed) AT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-018419-14 Sponsor Protocol Number: CAMN107A2120 Start Date*: 2010-10-27
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-center, open-label, pharmacokinetic study of oral nilotinib in pediatric patients with Gleevec® (imatinib)-resistant/intolerant Ph+ CML chronic phase (CP) or accelerated phase (AP) or with ...
    Medical condition: pediatric patients with Gleevec® (imatinib)- resistant/intolerant Ph+ CML chronic phase (CP) or accelerated phase (AP) or with refractory/relapsed Ph+ ALL
    Disease: Version SOC Term Classification Code Term Level
    12.1 10009700 CML LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) DE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-007054-35 Sponsor Protocol Number: CAMN107A2404 Start Date*: 2009-08-17
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A RANDOMIZED PHASE III STUDY OF IMATINIB DOSE OPTIMIZATION COMPARED WITH NILOTINIB IN PATIENTS WITH CHRONIC MYELOGENOUS LEUKEMIA AND SUBOPTIMAL RESPONSE TO STANDARD-DOSE IMATINIB
    Medical condition: IMATINIB DOSE OPTIMIZATION COMPARED WITH NILOTINIB IN PATIENTS WITH CML AND SUBOPTIMAL RESPONSE TO STANDARD-DOSE IMATINIB
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2009-012616-40 Sponsor Protocol Number: CAMN107A2405 Start Date*: 2009-08-11
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients with Evidence of Persistent Leukemia by ...
    Medical condition: Chronic Myelogenous Leukemia in Chronic Phase
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Prematurely Ended) ES (Completed)
    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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