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Journal: Tumor Necrosis Factor-α Is Required for Mast Cell-Mediated Host Immunity Against Cutaneous Staphylococcus aureus Infection. (Pubmed Central) - Sep 14, 2019 In addition, S. aureus-induced MC activation was dependent on the c-kit receptor-activated phosphoinositide 3-kinase (PI3K)/AKT/P65-nuclear factor (NF-κB) pathway, which was confirmed by treatment with Masitinib (a c-kit receptor inhibitor), Wortmannin (a PI3K inhibitor), and pyrrolidine dithiocarbamate (a NF-κB inhibitor), respectively. The present study identifies the critical role of MCs in the host defense against S. aureus infection.
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Journal: Evidence for mast cells contributing to neuromuscular pathology in an inherited model of ALS. (Pubmed Central) - Jul 11, 2019 Masitinib also normalized macrophage infiltration, as well as regressive changes in Schwann cells and capillary networks observed in advanced paralysis. These findings provide evidence for mast cell contribution to distal axonopathy and paralysis progression in ALS, a mechanism that can be therapeutically targeted by masitinib.
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Trial primary completion date: Masitinib in Patients With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Jun 17, 2019 P3, N=721, Active, not recruiting, These findings provide evidence for mast cell contribution to distal axonopathy and paralysis progression in ALS, a mechanism that can be therapeutically targeted by masitinib. Trial primary completion date: Apr 2019 --> Dec 2019
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Trial completion date, Trial primary completion date: Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis (clinicaltrials.gov) - Apr 30, 2019 P3, N=656, Active, not recruiting, Trial completion date: Mar 2019 --> Jun 2020 | Trial primary completion date: Mar 2019 --> Jun 2019 Trial completion date: Mar 2019 --> Sep 2020 | Trial primary completion date: Mar 2019 --> Sep 2019
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Enrollment closed, Combination therapy, Metastases: AB12005: Masitinib Plus Gemcitabine in Pancreatic Cancer (clinicaltrials.gov) - Feb 4, 2019 P3, N=330, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
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Trial completion date, Trial primary completion date, Combination therapy, Metastases: AB12005: Masitinib Plus Gemcitabine in Pancreatic Cancer (clinicaltrials.gov) - Jan 3, 2019 P3, N=330, Recruiting, Trial primary completion date: Dec 2018 --> Dec 2020 Trial completion date: Dec 2021 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Jun 2020
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Trial completion date, Combination therapy, Metastases: Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - Dec 30, 2018 P3, N=580, Recruiting, Trial completion date: Dec 2021 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Jun 2020 Trial completion date: Dec 2021 --> Sep 2020
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Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Stroma: Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST) (clinicaltrials.gov) - Dec 14, 2018 P3, N=335, Terminated, Trial completion date: Dec 2021 --> Sep 2020 N=222 --> 335 | Trial completion date: Dec 2013 --> Jul 2018 | Recruiting --> Terminated | Trial primary completion date: Jun 2013 --> Jul 2018; Sponsor decision based on portfolio prioritization
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Trial completion date, Trial primary completion date, Combination therapy, Metastases: Masitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) - Dec 13, 2018 P3, N=186, Terminated, N=222 --> 335 | Trial completion date: Dec 2013 --> Jul 2018 | Recruiting --> Terminated | Trial primary completion date: Jun 2013 --> Jul 2018; Sponsor decision based on portfolio prioritization Trial completion date: Jun 2018 --> Dec 2017 | Trial primary completion date: Jun 2018 --> Dec 2017
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Trial completion date, Combination therapy: Masitinib in Refractory Active Rheumatoid Arthritis (clinicaltrials.gov) - Dec 10, 2018 P2b, N=324, Terminated, Trial completion date: Jun 2018 --> Feb 2017 | Trial primary completion date: Jun 2018 --> Feb 2017 Trial completion date: Jun 2018 --> Sep 2016
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Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy: Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients (clinicaltrials.gov) - Dec 10, 2018 P3, N=495, Not yet recruiting, N=68 --> 248 Trial completion date: Sep 2019 --> May 2024 | Initiation date: Sep 2017 --> May 2019 | Trial primary completion date: Sep 2018 --> May 2021
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Enrollment change, Trial completion date, Trial primary completion date: Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids (clinicaltrials.gov) - Dec 7, 2018 P3, N=420, Active, not recruiting, Trial completion date: Sep 2019 --> May 2024 | Initiation date: Sep 2017 --> May 2019 | Trial primary completion date: Sep 2018 --> May 2021 N=300 --> 420 | Trial completion date: Dec 2015 --> Mar 2019 | Trial primary completion date: Dec 2013 --> Mar 2019
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Trial completion date, Trial primary completion date, Combination therapy: Masitinib in Refractory Active Rheumatoid Arthritis (clinicaltrials.gov) - Dec 6, 2018 P2b, N=324, Terminated, Active, not recruiting --> Completed Trial completion date: Dec 2015 --> Jun 2018 | Trial primary completion date: Dec 2013 --> Jun 2018
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Enrollment closed, Phase classification, Enrollment change, Trial completion date: Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis (clinicaltrials.gov) - Dec 6, 2018 P3, N=656, Active, not recruiting, Trial completion date: Dec 2015 --> Jun 2018 | Trial primary completion date: Dec 2013 --> Jun 2018 Recruiting --> Active, not recruiting | Phase classification: P2/3 --> P3 | N=450 --> 656 | Trial completion date: Jul 2019 --> Mar 2019
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Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Surgery, Stroma: Masitinib in Patients With Localized, Primary GIST After Complete Surgery and With High Risk of Recurrence (clinicaltrials.gov) - Dec 5, 2018 P3, N=7, Terminated, N=300 --> 147 | Trial completion date: Dec 2014 --> Jun 2018 | Recruiting --> Terminated | Trial primary completion date: Apr 2013 --> Jun 2018; Sponsor decision based on portfolio prioritization N=330 --> 7 | Trial completion date: Dec 2016 --> Jul 2018 | Not yet recruiting --> Terminated | Trial primary completion date: Mar 2014 --> Jun 2018; Sponsor decision based on portfolio prioritization
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Enrollment change, Trial completion date, Trial primary completion date: Masitinib in Patients With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Dec 5, 2018 P3, N=721, Active, not recruiting, N=330 --> 7 | Trial completion date: Dec 2016 --> Jul 2018 | Not yet recruiting --> Terminated | Trial primary completion date: Mar 2014 --> Jun 2018; Sponsor decision based on portfolio prioritization N=396 --> 721 | Trial completion date: Dec 2016 --> Oct 2019 | Trial primary completion date: Dec 2015 --> Apr 2019
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Enrollment open, Phase classification, Trial completion date, Trial primary completion date, Combination therapy, Metastases: Masitinib in Combination With Gemcitabine in Advanced/Metastatic Epithelial Ovarian Cancer Patients (clinicaltrials.gov) - Dec 5, 2018 P2/3, N=68, Recruiting, N=396 --> 721 | Trial completion date: Dec 2016 --> Oct 2019 | Trial primary completion date: Dec 2015 --> Apr 2019 Active, not recruiting --> Recruiting | Phase classification: P2 --> P2/3 | Trial completion date: Jun 2018 --> Dec 2020 | Trial primary completion date: Apr 2018 --> Dec 2020
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Enrollment change, Trial termination, Combination therapy, Metastases: Masitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) - Dec 5, 2018 P3, N=186, Terminated, Active, not recruiting --> Recruiting | Phase classification: P2 --> P2/3 | Trial completion date: Jun 2018 --> Dec 2020 | Trial primary completion date: Apr 2018 --> Dec 2020 N=550 --> 186 | Recruiting --> Terminated; Sponsor decision based on portfolio prioritization
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Trial completion, Enrollment change: Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis (clinicaltrials.gov) - Dec 3, 2018 P3, N=135, Completed, N=550 --> 186 | Recruiting --> Terminated; Sponsor decision based on portfolio prioritization Recruiting --> Completed | N=200 --> 135
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