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Clinical trials for Cedazuridine

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   44379   clinical trials with a EudraCT protocol, of which   7391   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    6 result(s) found for: Cedazuridine. Displaying page 1 of 1.
    EudraCT Number: 2020-004772-18 Sponsor Protocol Number: ASTX727-07 Start Date*: 2022-05-30
    Sponsor Name:Astex Pharmaceuticals, Inc.
    Full Title: A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination with Venetoclax in Adult Patients with Acute Myeloid Leukemia
    Medical condition: Acute Myeloid Leukemia (AML)
    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
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2019-003281-40 Sponsor Protocol Number: ASTX727-03 Start Date*: 2021-10-19
    Sponsor Name:Taiho Oncology, Inc.
    Full Title: A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)
    Medical condition: Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) ES (Restarted) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003942-18 Sponsor Protocol Number: ASTX727-06 Start Date*: 2021-09-03
    Sponsor Name:Taiho Oncology, Inc.
    Full Title: An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
    Medical condition: Acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or solid tumors
    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
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065252 Solid tumor LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009018 Chronic myelomonocytic leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Trial now transitioned) BG (Trial now transitioned) ES (Completed) LT (Completed) HU (Trial now transitioned) AT (Ongoing) FR (Completed) DE (Trial now transitioned) IT (Completed) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003395-12 Sponsor Protocol Number: ASTX727-02 Start Date*: 2019-11-14
    Sponsor Name:Astex Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Open-Label, Crossover Study of ASTX727 (Cedazuridine and Decitabine Fixed-Dose Combination) versus IV Decitabine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Mye...
    Medical condition: Acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009018 Chronic myelomonocytic leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) CZ (Completed) HU (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-001076-34 Sponsor Protocol Number: ABNL-MARRO-001 Start Date*: 2023-06-12
    Sponsor Name:Theradex (Europe) Ltd.
    Full Title: The ABNL-MARRO 001 Study: A Phase 1/2 Study of Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes
    Medical condition: Myelodysplastic syndrome/Myeloproliferative Neoplasm Overlap Syndromes
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077465 Myeloproliferative neoplasm 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: ES (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003685-40 Sponsor Protocol Number: GFM-DACORAL-DLI Start Date*: 2020-12-28
    Sponsor Name:Groupe Francophone des Myélodysplasies (GFM)
    Full Title: A PHASE II PROSPECTIVE STUDY “GFM-DACORAL-DLI” ASTX727 AND DONOR LYMPHOCYTE INFUSIONS (DLI) AFTER ALLOGENEIC STEM CELL TRANSPLANTATION (ALLO SCT) IN VERY HIGH RISK MDS OR AML PATIENTS
    Medical condition: Patients with high risk myelodysplastic syndrome or acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    21.0 100000004864 10028534 Myelodysplastic syndrome NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    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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