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Clinical trials for Fedratinib

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   44367   clinical trials with a EudraCT protocol, of which   7389   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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    7 result(s) found for: Fedratinib. Displaying page 1 of 1.
    EudraCT Number: 2018-003411-21 Sponsor Protocol Number: FEDR-MF-002 Start Date*: 2019-05-14
    Sponsor Name:Impact Biomedicines, Inc., a Wholly Owned Subsidiary of Celgene Corporation
    Full Title: A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy in subjects with DIPSS - intermediate or high-risk primary ...
    Medical condition: Primary myelofibrosis, post-polycythemia vera myelofibrosis , or post-essential thrombocythemia myelofibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) ES (Ongoing) IE (Trial now transitioned) NL (Completed) AT (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002071-35 Sponsor Protocol Number: CA011-023 Start Date*: 2022-10-26
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 1b/2 Study of BMS-986158 Monotherapy and in Combination with Either Ruxolitinib or Fedratinib in Participants with DIPSS-Intermediate or High Risk Myelofibrosis
    Medical condition: DIPSS-Intermediate or High Risk Myelofibrosis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000879 Acute myelofibrosis LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PL (Trial now transitioned) GR (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003650-23 Sponsor Protocol Number: KKSH178 Start Date*: 2022-07-29
    Sponsor Name:Martin-Luther-Universität Halle-Wittenberg
    Full Title: Fedratinib in Combination with CC-486, a Hypomethylating Agent, in Patients with Accelerated Phase Myelofibrosis
    Medical condition: Myeloproliferative neoplasm in accelerated phase (MPN-AP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077465 Myeloproliferative neoplasm PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003123-42 Sponsor Protocol Number: INCB39110-213 Start Date*: 2021-03-17
    Sponsor Name:Incyte Corporation
    Full Title: A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post–Polycythemi...
    Medical condition: Primary Myelofibrosis or Secondary Myelofibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) FR (Completed) DE (Completed) ES (Prematurely Ended) BE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000557-27 Sponsor Protocol Number: M20-178 Start Date*: 2020-09-14
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination with Ruxolitinib Versus Best Available Therapy in Subjects with Relapsed/Refractory Myelofibrosis...
    Medical condition: Myelofibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) GB (GB - no longer in EU/EEA) FR (Completed) BE (Completed) SE (Prematurely Ended) PL (Prematurely Ended) GR (Completed) AT (Completed) DK (Prematurely Ended) IT (Prematurely Ended) BG (Prematurely Ended) HR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-024473-39 Sponsor Protocol Number: CINC424A2401 Start Date*: 2011-06-22
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, multicenter, expanded access study of INC424 for patients with primary myelofibrosis (PMF) of post polycythemia vera myelofibrosis (PPV MF) or post-essential thrombocythemia myelofib...
    Medical condition: primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV MF) or Post essential thrombocythemia myelofibrosis (PET-MF)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) BE (Completed) DE (Completed) ES (Completed) GR (Completed) HU (Completed) PT (Completed) SK (Completed) PL (Completed) IT (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2018-003811-23 Sponsor Protocol Number: IMG-7289-CTP-102 Start Date*: 2019-12-11
    Sponsor Name:Imago BioSciences, Inc.
    Full Title: A Multi-Center, Open Label Study to Assess the Safety, Steady­ State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients with Myelofibrosis
    Medical condition: Myelofibrosis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074692 Post essential thrombocythaemia myelofibrosis LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074691 Post polycythaemia vera myelofibrosis LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077161 Primary myelofibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (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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