Flag of the European Union EU Clinical Trials Register Help

Clinical trials for French–American–British classification

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   44336   clinical trials with a EudraCT protocol, of which   7366   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    12 result(s) found for: French–American–British classification. Displaying page 1 of 1.
    EudraCT Number: 2015-001476-22 Sponsor Protocol Number: 04-30 Start Date*: 2016-02-16
    Sponsor Name:Onconova Therapeutics, Inc.
    Full Title: A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician’s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent
    Medical condition: Myelodysplastic Syndrome
    Disease: Version SOC Term Classification Code Term Level
    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 (Prematurely Ended) GB (GB - no longer in EU/EEA) AT (Prematurely Ended) IE (Prematurely Ended) CZ (Prematurely Ended) FR (Prematurely Ended) HR (Completed) PL (Prematurely Ended) SE (Completed) BE (Prematurely Ended) NL (Prematurely Ended) HU (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001418-13 Sponsor Protocol Number: TED10893 Start Date*: 2014-11-04
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: A Phase I Dose Escalation Safety and Pharmacokinetic Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 In Patients with Selected CD38+ Hemat...
    Medical condition: Haematological malignancy
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066476 Haematological malignancy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) GR (Completed) GB (GB - no longer in EU/EEA) FI (Completed) BE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000672-15 Sponsor Protocol Number: 09-07 Start Date*: 2014-03-18
    Sponsor Name:Onconova Therapeutics, Inc.
    Full Title: A Single-arm Study to Assess the Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Intermediate-1, Myelodysplastic Syndrome Patients Based on the International Prognostic Scor...
    Medical condition: Myelodysplastic Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-004811-31 Sponsor Protocol Number: GIMEMA MDS 0205 Start Date*: 2006-05-16
    Sponsor Name:G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL ADULTO
    Full Title: An open label, phase II, non randomized, clinical trial of chemotherapy treatment with 5-Azacytidine plus valproic acid and eventually atra for patients diagnosed with Intermediate II and high risk...
    Medical condition: Intermediate II and high risk Myelodysplastic syndrome MDS
    Disease: Version SOC Term Classification Code Term Level
    8.1 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002301-61 Sponsor Protocol Number: 2215-CL-0603 Start Date*: 2020-01-14
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Ty...
    Medical condition: FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-002675-29 Sponsor Protocol Number: CC-486-MDS-006 Start Date*: 2015-06-19
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 2, International, Multicenter, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of CC-486 (oral azacitidine) in Subjects With Myelodysplastic Syndromes Who Fail to Achieve a...
    Medical condition: Myelodysplastic syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) GB (GB - no longer in EU/EEA) BE (Completed) ES (Ongoing) DE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000918-37 Sponsor Protocol Number: TRC112121 Start Date*: 2014-06-20
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A randomized, double-blind, placebo-controlled, phase III, multi-centre study of eltrombopag or placebo in combination with azacitidine in subjects with IPSS intermediate-1, intermediate 2 and high...
    Medical condition: Thrombocytopenic patients with myelodysplastic syndromes
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028534 Myelodysplastic syndrome NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) SE (Prematurely Ended) DE (Prematurely Ended) DK (Prematurely Ended) AT (Prematurely Ended) CZ (Prematurely Ended) GR (Prematurely Ended) IE (Prematurely Ended) BE (Prematurely Ended) NO (Prematurely Ended) ES (Prematurely Ended) HU (Completed)
    Trial results: View results
    EudraCT Number: 2019-004896-38 Sponsor Protocol Number: CL1-64315-004 Start Date*: 2020-12-07
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: Phase I/II, international, multicentre, open-label, non-randomised, non-comparative study evaluating the safety, tolerability and clinical activity of intravenously administered S64315, a selective...
    Medical condition: Acute Myeloid Leukaemia (AML)
    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: FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-000261-12 Sponsor Protocol Number: CNTO328MDS2001 Start Date*: 2011-09-28
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Subjects with International ...
    Medical condition: Anemia associated with Low- or Intermediate-1-Risk Myelodysplastic Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028534 Myelodysplastic syndrome NOS LLT
    14.1 10005329 - Blood and lymphatic system disorders 10002272 Anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Prematurely Ended) SE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-001838-19 Sponsor Protocol Number: KER050-MD-201 Start Date*: Information not available in EudraCT
    Sponsor Name:Keros Therapeutics, Inc.
    Full Title: A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
    Medical condition: Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS).
    Disease: Version SOC Term Classification Code Term Level
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    20.0 10005329 - Blood and lymphatic system disorders 10002272 Anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-022884-36 Sponsor Protocol Number: EPOANE3021 (Epoetin alfa) Start Date*: 2011-07-04
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Versus Placebo in Anemic Patients with IPSS Low- or intermediate 1 Risk Myelodysplastic Syndromes
    Medical condition: Anemic Patients With IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes
    Disease: Version SOC Term Classification Code Term Level
    13.1 10005329 - Blood and lymphatic system disorders 10002272 Anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2015-002874-19 Sponsor Protocol Number: 63935937MDS3001 Start Date*: 2015-11-23
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Study to Evaluate Imetelstat (JNJ-63935937) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Sti...
    Medical condition: Myelodysplastic syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004851 10028536 Myelodysplastic syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) CZ (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 20 12:31:30 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA