itacitinib (INCB039110) / Incyte 
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 24 Diseases   21 Trials   21 Trials   500 News 


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  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial primary completion date, Monotherapy:  Itacitinib for Low Risk GVHD (clinicaltrials.gov) -  Nov 6, 2020   
    P2,  N=70, Recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Dec 2021 --> Apr 2022 | Trial primary completion date: Dec 2020 --> Apr 2021
  • ||||||||||  itacitinib (INCB039110) / Incyte, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] A Single-Arm, Open-Label Phase 1 Study of Itacitinib (ITA) with Calcineurin Inhibitor (CNI)–Based Interventions for Prophylaxis of Graft-Versus-Host Disease (GVHD; GRAVITAS-119) (Channel 23 (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_3082;    
    P1
    Pts received oral ITA 200 mg once daily (QD) beginning 3 d before HCT + tacrolimus (Tac)/methotrexate (MTX) or cyclosporine A (CSA)/mycophenolate mofetil (MMF) ± antithymocyte globulin (ATG) per institutional practice...Busulfan/fludarabine (51%) and a fludarabine/melphalan reduced-intensity regimen (18%) were the most common conditioning regimens; 11% of regimens contained total body irradiation...8 pts in the +ATG group received post-transplant rituximab for EBV infection (n=7) and/or azaciditine maintenance therapy (n=3)...1 pt with MF did not achieve ANC recovery on Day 28. An ITA + Tac + post-transplant cyclophosphamide cohort is currently being investigated in GRAVITAS-119.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Phase classification, Enrollment change, Trial completion date, Trial primary completion date:  GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (clinicaltrials.gov) -  Oct 28, 2020   
    P2/3,  N=401, Recruiting, 
    An ITA + Tac + post-transplant cyclophosphamide cohort is currently being investigated in GRAVITAS-119. Phase classification: P3 --> P2/3 | N=266 --> 401 | Trial completion date: Oct 2023 --> Feb 2025 | Trial primary completion date: Aug 2023 --> Jan 2024
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy:  A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease (clinicaltrials.gov) -  Oct 28, 2020   
    P1/2,  N=1, Terminated, 
    Phase classification: P3 --> P2/3 | N=266 --> 401 | Trial completion date: Oct 2023 --> Feb 2025 | Trial primary completion date: Aug 2023 --> Jan 2024 N=60 --> 1 | Trial completion date: Jun 2023 --> Oct 2020 | Recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Oct 2020; Adverse events of the first patient
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date:  Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation (clinicaltrials.gov) -  Oct 28, 2020   
    P2,  N=0, Withdrawn, 
    N=60 --> 1 | Trial completion date: Jun 2023 --> Oct 2020 | Recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Oct 2020; Adverse events of the first patient N=60 --> 0 | Trial completion date: Aug 2021 --> Sep 2020 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2021 --> Sep 2020
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Oct 19, 2020   
    P1/2,  N=59, Active, not recruiting, 
    N=60 --> 0 | Trial completion date: Aug 2021 --> Sep 2020 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2021 --> Sep 2020 Trial completion date: Sep 2021 --> Mar 2021 | Trial primary completion date: Sep 2020 --> Feb 2021
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment change, Trial completion date:  An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis (clinicaltrials.gov) -  Jul 22, 2020   
    P2,  N=87, Active, not recruiting, 
    These data combined with phase 3 data will inform final dosing recommendations. N=125 --> 87 | Trial completion date: Jun 2020 --> Oct 2020
  • ||||||||||  Journal:  Potential Drugs Targeting Early Innate Immune Evasion of SARS-Coronavirus 2 via 2'-O-Methylation of Viral RNA. (Pubmed Central) -  May 23, 2020   
    After molecular dynamics calculations of the stability of the binding modes of high-scoring nsp16/nsp10-drug complexes, we considered their pharmacological overlapping with functional modules of the virus-host interactome that is relevant to the viral lifecycle, and to the clinical features of COVID-19. Some of the predicted drugs (e.g., tegobuvir, sonidegib, siramesine, antrafenine, bemcentinib, itacitinib, or phthalocyanine) might be suitable for repurposing to pharmacologically reactivate innate immune restriction and antagonism of SARS-CoV-2 RNAs lacking 2'-O-methylation.
  • ||||||||||  Decadron (dexamethasone) / Merck (MSD), Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
    [VIRTUAL] IMPACT OF JAK INHIBITORS ON MACROPHAGE POLARISATION: PERSPECTIVES FOR SYSTEMIC SCLEROSIS () -  May 22, 2020 - Abstract #EULAR2020EULAR_2293;    
    Jak inhibitors can limit M1 and M2 polarisation state in vitro, with a more significant effect of the Jak2-Jak1 inhibitor ruxolitinib. The relevance of these results in MDM from SSc patients and in vivo models of SSc is still to be determined.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Combination therapy:  GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease (clinicaltrials.gov) -  May 14, 2020   
    P3,  N=439, Active, not recruiting, 
    Conclusion ITA added to CS for the initial treatment of aGVHD did not significantly improve Day 28 ORR, 6-mo NRM, or OS vs PBO plus CS; however, post-hoc analysis showed significant association with Day 28 CR rates and further analyses are needed to understand if this translated into clinical benefit. Trial completion date: Mar 2020 --> Dec 2020
  • ||||||||||  itacitinib (INCB039110) / Incyte, Abraxane (albumin-bound paclitaxel) / BMS, Otsuka, gemcitabine / Generic mfg.
    P1/2 data, Journal:  A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. (Pubmed Central) -  Mar 26, 2020   
    P1b/2
    Itacitinib plus chemotherapy demonstrated acceptable safety and clinical activity in patients with advanced solid tumors including pancreatic cancers. This study was terminated early (sponsor's decision) based on negative phase III results for a JAK1/2 inhibitor in previously treated advanced pancreatic cancer.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment open, Combination therapy:  Itacitinib + Everolimus in Hodgkin Lymphoma (clinicaltrials.gov) -  Mar 24, 2020   
    P1/2,  N=28, Recruiting, 
    This study was terminated early (sponsor's decision) based on negative phase III results for a JAK1/2 inhibitor in previously treated advanced pancreatic cancer. Active, not recruiting --> Recruiting
  • ||||||||||  itacitinib (INCB039110) / Incyte, Keytruda (pembrolizumab) / Merck (MSD)
    Enrollment closed, Metastases:  Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Mar 24, 2020   
    P2,  N=48, Active, not recruiting, 
    Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment closed, Combination therapy:  Itacitinib + Everolimus in Hodgkin Lymphoma (clinicaltrials.gov) -  Mar 23, 2020   
    P1/2,  N=28, Active, not recruiting, 
    Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy:  Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects (clinicaltrials.gov) -  Mar 16, 2020   
    P1/2,  N=2, Terminated, 
    Not yet recruiting --> Recruiting | Initiation date: Dec 2019 --> May 2020 N=150 --> 2 | Trial completion date: Nov 2022 --> Feb 2020 | Recruiting --> Terminated | Trial primary completion date: Nov 2022 --> Feb 2020; The study was terminated due to insufficient efficacy in a separate phase III study
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date:  An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis (clinicaltrials.gov) -  Feb 25, 2020   
    P2,  N=125, Active, not recruiting, 
    Preclinical data reveal insights into vulnerabilities created in myeloma cells by BET protein inhibition and potential strategies that can be leveraged in clinical studies to enhance the activity of INCB054329. Trial completion date: Jan 2020 --> Jun 2020