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Clinical trials for masitinib

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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    37 result(s) found for: masitinib. Displaying page 2 of 2.
    EudraCT Number: 2010-021218-50 Sponsor Protocol Number: AB09004 Start Date*: 2011-05-25
    Sponsor Name:AB Science
    Full Title: A multicenter, double-blind, placebo-controlled, randomised, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib in patients with mild to moderate Alzheimer’s disease
    Medical condition: mild to moderate Alzheimer’s disease
    Disease: Version SOC Term Classification Code Term Level
    12.1 10012271 Dementia Alzheimer's type LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prohibited by CA) ES (Completed) SK (Prohibited by CA) PL (Completed) GR (Completed) GB (GB - no longer in EU/EEA) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021091-28 Sponsor Protocol Number: AB10004 Start Date*: 2014-12-18
    Sponsor Name:AB Science
    Full Title: A multicenter, randomised, open-label, three-parallel groups, phase 2-3 study to evaluate the efficacy and safety of masitinib with dexamethasone, gemcitabine with dexamethasone and the combination...
    Medical condition: Relapsed or refractory Peripheral T-cell lymphoma
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061871 Non-Hodgkin's lymphoma transformed recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GR (Prematurely Ended) ES (Prematurely Ended) GB (Prematurely Ended) HU (Prematurely Ended) SK (Prohibited by CA)
    Trial results: (No results available)
    EudraCT Number: 2012-005586-13 Sponsor Protocol Number: AB12009 Start Date*: 2013-08-19
    Sponsor Name:AB SCIENCE
    Full Title: A prospective, multicentre, randomised, double-blind, placebo-controlled, phase 2a study to compare the efficacy and the safety of 24-week treatment with masitinib versus placebo in patients with s...
    Medical condition: Patients with severe COPD
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) SK (Prohibited by CA) GR (Completed)
    Trial results: View results
    EudraCT Number: 2013-000490-79 Sponsor Protocol Number: AB12006 Start Date*: 2015-09-18
    Sponsor Name:AB Science
    Full Title: A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5...
    Medical condition: Metastatic colorectal cancer after 1 previous line of treatment
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Prematurely Ended) ES (Completed) CZ (Completed) SK (Prematurely Ended) HU (Completed) GB (Prematurely Ended) FR (Completed) CY (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-002179-21 Sponsor Protocol Number: AB21004 Start Date*: 2022-10-07
    Sponsor Name:AB Science
    Full Title: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib as add-on therapy in patients with mild to moderate Alzhei...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10001897 Alzheimer's disease (incl subtypes) HLT
    20.0 100000004852 10001896 Alzheimer's disease LLT
    24.1 100000004852 10086384 Early onset Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Ongoing) GR (Completed) PL (Prematurely Ended) PT (Prematurely Ended) HU (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-000491-14 Sponsor Protocol Number: AB12008 Start Date*: 2014-10-10
    Sponsor Name:AB Science
    Full Title: A prospective, multicentre, open-label, centrally allocated, active-controlled, phase 2 study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alo...
    Medical condition: Advanced/metastatic epithelial ovarian cancer in second line being refractory to first line platinum treatment or in third line
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033158 Ovarian epithelial cancer metastatic PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Ongoing) FR (Ongoing) GB (GB - no longer in EU/EEA) SK (Prohibited by CA) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-017918-69 Sponsor Protocol Number: AB08026 Start Date*: 2011-01-14
    Sponsor Name:AB Science
    Full Title: A prospective, multicenter, randomized, open-label, active-controlled, two-parallel groups, phase 3 study to compare the efficacy and safety of masitinib at 7.5 mg/kg/day to dacarbazine in the trea...
    Medical condition: Mélanome non-opérable ou métastasé de stade 3 ou de stade 4, portant une mutation dans le domaine juxta-membranaire de c-kit
    Disease: Version SOC Term Classification Code Term Level
    12.1 10025670 Malignant melanoma stage III LLT
    12.1 10025671 Malignant melanoma stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) SK (Prematurely Ended) DE (Prohibited by CA) CZ (Completed) HU (Prematurely Ended) AT (Completed) ES (Prematurely Ended) IT (Prohibited by CA) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022793-14 Sponsor Protocol Number: AB10007 Start Date*: 2011-08-05
    Sponsor Name:AB Science
    Full Title: A prospective, multicentre, open-label, randomised, uncontrolled, phase 1/2 study to evaluate the efficacy and safety of masitinib in combination with 5-fluorouracil (5-FU) or capecitabine, or masi...
    Medical condition: gastric or gastro-oesophageal junction metastatic adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    12.1 10063916 Metastatic gastric cancer PT
    12.1 10062878 Gastrooesophageal cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001447-39 Sponsor Protocol Number: AB15003 Start Date*: 2019-10-21
    Sponsor Name:AB SCIENCE
    Full Title: A 24-week with possible extension, prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, phase III study to compare efficacy and safety ...
    Medical condition: Smouldering or Indolent Severe Systemic mastocytosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Prematurely Ended) PL (Trial now transitioned) RO (Ongoing) LT (Completed) NL (Temporarily Halted) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-021219-17 Sponsor Protocol Number: AB07002 Start Date*: 2011-09-12
    Sponsor Name:AB Science
    Full Title: Estudio prospectivo Fase III, multicéntrico, randomizado, doble ciego, de dos grupos paralelos, controlado con placebo y de 96 semanas de duración, para comparar la eficacia y seguridad de masitini...
    Medical condition: Pacientes con esclerosis múltiple primaria progresiva o secundaria progresiva sin recidiva
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10063401 Primary progressive multiple sclerosis PT
    14.0 10029205 - Nervous system disorders 10063400 Secondary progressive multiple sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Prohibited by CA) SK (Prohibited by CA) GR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-020803-63 Sponsor Protocol Number: AB07015 Start Date*: 2010-10-18
    Sponsor Name:AB Science
    Full Title: A prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the t...
    Medical condition: Severe Persistent Asthma
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003553 Asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prohibited by CA) CZ (Completed) BG (Completed) DE (Prematurely Ended) SK (Completed) ES (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2010-022646-24 Sponsor Protocol Number: AB10005 Start Date*: 2015-04-15
    Sponsor Name:AB Science
    Full Title: A prospective, multicentre, open-label, randomized, uncontrolled, phase 1/2 study to evaluate efficacy and safety of masitinib in combination with gemcitabine or carboplatin or capecitabine in pati...
    Medical condition: Metastatic or locally advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) SK (Prohibited by CA) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022744-21 Sponsor Protocol Number: AB08003 Start Date*: 2013-06-05
    Sponsor Name:AB Science
    Full Title: A 12-week, proof of concept prospective, randomized, double blind, phase 2a study to compare safety and efficacy of masitinib to placebo in the treatment of mood disorders in patients with antidepr...
    Medical condition: mood disorders associated to major depression or dysthymic disorder
    Disease: Version SOC Term Classification Code Term Level
    16.0 10037175 - Psychiatric disorders 10013982 Dysthymic disorder PT
    16.0 10037175 - Psychiatric disorders 10012374 Depressed mood PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-021495-29 Sponsor Protocol Number: AB09001 Start Date*: 2010-10-29
    Sponsor Name:AB Science
    Full Title: A prospective, multicentre, randomised, double-blind, placebo-controlled, phase 2a study to compare the efficacy and the safety of 24-week treatment with masitinib at 6 mg/kg/day versus placebo in ...
    Medical condition: severe Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10009033 Chronic obstructive pulmonary disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prohibited by CA)
    Trial results: View results
    EudraCT Number: 2012-004222-25 Sponsor Protocol Number: AB11003 Start Date*: 2013-11-26
    Sponsor Name:AB Science
    Full Title: A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 4-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the...
    Medical condition: Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    18.1 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) SK (Prohibited by CA) GR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-020992-21 Sponsor Protocol Number: AB06012 Start Date*: 2014-03-25
    Sponsor Name:AB Science
    Full Title: A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    17.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) CZ (Prematurely Ended) SK (Prematurely Ended) ES (Prematurely Ended) GR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-022620-77 Sponsor Protocol Number: AB10006 Start Date*: 2013-07-15
    Sponsor Name:AB Science
    Full Title: A prospective, multicentre, open-label, randomised, uncontrolled, phase 1/2 study to evaluate efficacy and safety of masitinib in combination with etoposide, or masitinib in combination with irinot...
    Medical condition: hepatocellular carcinoma
    Disease: Version SOC Term Classification Code Term Level
    12.1 10019830 Hepatocellular carcinoma resectable LLT
    12.1 10019828 Hepatocellular carcinoma non-resectable LLT
    12.1 10019829 Hepatocellular carcinoma recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Completed) SK (Prohibited by CA) CZ (Completed) GR (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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