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Clinical trials for Pevonedistat

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   44339   clinical trials with a EudraCT protocol, of which   7369   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: Pevonedistat. Displaying page 1 of 1.
    EudraCT Number: 2019-002934-35 Sponsor Protocol Number: ADVL1615 Start Date*: 2021-05-21
    Sponsor Name:Children's Oncology Group
    Full Title: A Phase 1 Study of Pevonedistat (MLN4924, IND# 136078) a NEDD8 Activating Enzyme (NAE) Inhibitor, in Combination With Temozolomide and Irinotecan in Pediatric Patients With Recurrent or Refractory ...
    Medical condition: This trial studies the side effects and best dose of pevonedistat when given together with irinotecan and temozolomide in treating patients with solid tumors or lymphoma that have come back after a...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10049516 Malignant tumor LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000318-40 Sponsor Protocol Number: Pevonedistat-3001 Start Date*: 2018-04-25
    Sponsor Name:Millennium Pharmaceuticals, Inc. (Takeda)
    Full Title: A Phase 3, Randomized, Controlled, Open-Label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic ...
    Medical condition: Higher-Risk Myelodysplastic Syndromes (MDS) Chronic Myelomonocytic Leukemia (CMML) Low-Blast Acute Myelogenous Leukemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10054350 Chronic myelomonocytic leukemia LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024348 Leukemia myelogenous LLT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024330 Leukemia acute LLT
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067387 Myelodysplastic syndrome transformation PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009018 Chronic myelomonocytic leukaemia PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) CZ (Completed) ES (Completed) FR (Completed) BE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000221-37 Sponsor Protocol Number: Pevonedistat-2001 Start Date*: 2016-02-22
    Sponsor Name:Millennium Pharmaceuticals, Inc. (Takeda)
    Full Title: A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients with Higher-Risk Myelodysplasti...
    Medical condition: Higher-risk myelodysplastic syndromes (MDS), Chronic myelomonocytic leukemia (CMML), Low-blast acute myelogenous leukemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10054350 Chronic myelomonocytic leukemia LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024348 Leukemia myelogenous LLT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024330 Leukemia acute LLT
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067387 Myelodysplastic syndrome transformation PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009018 Chronic myelomonocytic leukaemia PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) NL (Completed) ES (Completed) BE (Completed) DE (Completed) IE (Completed) BG (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002935-27 Sponsor Protocol Number: ADVL1712 Start Date*: 2021-05-21
    Sponsor Name:National Cancer Institute
    Full Title: A Feasibility Trial of MLN4924 (Pevonedistat,TAK924) Given in Combination With Azacitidine, Fludarabine, and Cytarabine, in Children, Adolescents, and Young Adults With Relapsed or Refractory Acute...
    Medical condition: This trial studies the side effects and how well pevonedistat, azacitidine, fludarabine phosphate, and cytarabine work in treating patients with acute myeloid leukemia that has come back or has not...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10024330 Leukemia acute LLT
    21.0 100000004864 10024349 Leukemia myeloid LLT
    21.0 100000004864 10028534 Myelodysplastic syndrome NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-004536-37 Sponsor Protocol Number: SHAPE Start Date*: 2020-10-19
    Sponsor Name:Leipzig University
    Full Title: Treatment of MDS/AML patients with an impending hematological relapse with azacitidine alone or in combination with pevonedistat - a randomized phase 2 trial
    Medical condition: Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS) with impending hematological relapse
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001323-12 Sponsor Protocol Number: PEVOLAM Start Date*: 2020-09-23
    Sponsor Name:Fundación PETHEMA
    Full Title: A randomized phase III, multicentre, open label clinical trial comparing azacitidine plus pevonedistat versus azacitidine in Older/Unfit patients with newly diagnosed acute myeloid leukemia who are...
    Medical condition: Acute Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003117-33 Sponsor Protocol Number: Pevonedistat-2002 Start Date*: Information not available in EudraCT
    Sponsor Name:Millennium Pharmaceuticals, Inc.
    Full Title: A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unf...
    Medical condition: Acute Myeloid Leukemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024330 Leukemia acute LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024348 Leukemia myelogenous LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) IT (Trial now transitioned) FR (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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