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Clinical trials for Ivosidenib

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   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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    7 result(s) found for: Ivosidenib. Displaying page 1 of 1.
    EudraCT Number: 2018-000451-41 Sponsor Protocol Number: HO150 Start Date*: 2019-03-01
    Sponsor Name:HOVON Foundation
    Full Title: A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therap...
    Medical condition: AML or MDS-EB2 with a mutation in either IDH1 or IDH2
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001941 AML LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) FI (Trial now transitioned) LT (Trial now transitioned) SE (Trial now transitioned) BE (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned) IE (Trial now transitioned) DE (Trial now transitioned) AT (Trial now transitioned) DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-006895-17 Sponsor Protocol Number: MOLIVO-1 Start Date*: 2022-12-02
    Sponsor Name:Hannover Medical School
    Full Title: Phase Ia/IIb study of PHD inhibitor molidustat in combination with IDH1 inhibitor ivosidenib in IDH1-mutated relapsed/refractory AML or MDS/AML patients
    Medical condition: Adult patients with relapsed or refractory IDH1-mutated AML or relapsed/refractory MSD/AML with 10-19% bone marrow blasts at initial diagnosis and at screening (ECOG 0-2) after at least one prior l...
    Disease: Version SOC Term Classification Code Term Level
    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)
    Trial results: (No results available)
    EudraCT Number: 2017-003681-27 Sponsor Protocol Number: IDIOMEStudy Start Date*: 2018-12-07
    Sponsor Name:Groupe Francophone des Myelodysplasies
    Full Title: A single-arm phase II multicenter study of IDH1 (AG 120) inhibitor in patients with IDH1 mutated myelodysplastic syndrome
    Medical condition: Myelodysplastic syndrome, mutation IDH 1, inhibitor IDH-1
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-004907-30 Sponsor Protocol Number: AG120-C-009 Start Date*: 2017-09-13
    Sponsor Name:Agios Pharmaceuticals, Inc.
    Full Title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects ≥ 18 Years of Age with Previously Untreated Acute Myeloid Leukemia w...
    Medical condition: Acute Myeloid Leukemia with an IDH1 Mutation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) AT (Completed) CZ (Completed) NL (Ongoing) FR (Trial now transitioned) PL (Trial now transitioned) GB (GB - no longer in EU/EEA) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003040-20 Sponsor Protocol Number: MX39795 Start Date*: 2018-06-20
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A phase II, randomized, active-controlled, multi-center study comparing the efficacy and safety of targeted therapy or cancer immunotherapy guided by genomic profiling versus platinum-based chemoth...
    Medical condition: Cancer of Unknown Primary Site
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10032248 Other malignant neoplasm of unspecified site LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Completed) EE (Completed) IE (Completed) DE (Completed) CZ (Completed) FI (Completed) LV (Completed) HU (Completed) PL (Completed) FR (Completed) ES (Ongoing) BG (Completed) PT (Completed) HR (Completed) NO (Completed) NL (Completed) DK (Completed) CY (Prematurely Ended) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2015-003951-23 Sponsor Protocol Number: AG-221-AML-005 Start Date*: 2016-07-08
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 1b/2 Open-Label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 P...
    Medical condition: Newly diagnosed acute myeloid leukemia (AML) habouring an isocitrate dehydrogenase 1 (IDH1) or an isocitrate dehydrogenase 2 (IDH2) mutation, respectively, who are not candidates to receive intensi...
    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: DE (Trial now transitioned) PT (Completed) ES (Ongoing) NL (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-005117-72 Sponsor Protocol Number: AG120-C-005 Start Date*: 2017-04-24
    Sponsor Name:Agios Pharmaceuticals, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects with Nonresectable or Metastatic Cholangiocarcinoma with an IDH1 Mutation
    Medical condition: Nonresectable or Metastatic Cholangiocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10008594 Cholangiocarcinoma non-resectable LLT
    20.0 100000004864 10077846 Cholangiocarcinoma metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) ES (Completed) FR (Completed) IT (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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