INCB57643 / Incyte 
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 0 Diseases   1 Trial   1 Trial   8 News 
  • ||||||||||  Jakafi (ruxolitinib) / Novartis, Incyte, INCB57643 / Incyte
    Preclinical characterization of the BET inhibitor, INCB057643, in combination with ruxolitinib for treatment of myeloproliferative neoplasms (MPN) (Section 20; Poster Board #12) -  Mar 14, 2023 - Abstract #AACR2023AACR_8417;    
    Our data demonstrate that the combination of the BET inhibitor, INCB057643, with ruxolitinib can restore normal hematopoietic differentiation, reduce inflammatory gene expression, and inhibit pathogenic cell differentiation in preclinical models of MPN. INCB057643 is currently being evaluated in clinical studies as monotherapy and in combination with ruxolitinib in patients with MPN.Acknowledgments: Michelle Pusey and Gaurang Trivedi contributed equally to this study.
  • ||||||||||  INCB57643 / Incyte
    INCB057643 Monotherapy in Patients with Relapsed or Refractory Myelofibrosis: A Phase 1 Study (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_6178;    
    P1
    Treatment with a 4-mg qd dose of INCB057643 monotherapy in this patient population was generally well tolerated, with no treatment-related SAEs, no DLTs, and no TEAEs leading to treatment discontinuation. INCB057643 will be further evaluated at higher doses in dose-escalation and dose-expansion phases as monotherapy and in combination with ruxolitinib in patients with MF (preliminary combination data to be available for presentation).
  • ||||||||||  docetaxel / Generic mfg.
    Clinical, Journal, Combination therapy:  Efficacy of Novel Bromodomain and Extraterminal Inhibitors in Combination with Chemotherapy for Castration-Resistant Prostate Cancer. (Pubmed Central) -  Feb 2, 2022   
    INCB057643 will be further evaluated at higher doses in dose-escalation and dose-expansion phases as monotherapy and in combination with ruxolitinib in patients with MF (preliminary combination data to be available for presentation). Collectively, these results provide the first evidence of the therapeutic benefit obtainable by combining BETis with non-androgen receptor-targeted therapies for the treatment of mCRPC.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, INCB57643 / Incyte, milademetan (RAIN-32) / Rain Therap
    Journal, IO biomarker:  Aggressive B-cell Lymphoma with MYC/TP53 Dual Alterations Displays Distinct Clinicopathobiological Features and Response to Novel Targeted Agents. (Pubmed Central) -  Nov 21, 2021   
    In summary, these findings support sub-classification of DLBCL/HGBCL with dual MYC/TP53 alterations which demonstrates distinct pathobiological features and dismal survival with standard therapy therefore requiring additional targeted therapies. Implications: The clinical and pharmacologic studies suggest recognizing DLBCL with concomitant TP53 mutation and MYC abnormalities as a distinctive entity necessary for precision oncology practice.
  • ||||||||||  INCB57643 / Incyte
    Trial completion date, Trial primary completion date, Metastases:  LIMBER: Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms (clinicaltrials.gov) -  Nov 11, 2021   
    P1,  N=39, Recruiting, 
    Implications: The clinical and pharmacologic studies suggest recognizing DLBCL with concomitant TP53 mutation and MYC abnormalities as a distinctive entity necessary for precision oncology practice. Trial completion date: Mar 2024 --> Nov 2024 | Trial primary completion date: Mar 2024 --> Nov 2024
  • ||||||||||  INCB57643 / Incyte
    [VIRTUAL] A PHASE 1 STUDY OF INCB057643 MONOTHERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY MYELOFIBROSIS (INCB 57643-103) () -  May 13, 2021 - Abstract #EHA2021EHA_1904;    
    P1
    Methods Eligible patients must be aged ≥18 years with histologically confirmed primary or secondary (post-polycythemia vera, post-essential thrombocythemia) MF, have received ≥1 prior therapy including ruxolitinib, have no known clinically beneficial therapy available, have intermediate-2/high risk disease by Dynamic International Prognostic Scoring System, have ECOG PS 0–2, life expectancy ≥24 weeks, and willing to provide a bone marrow biopsy and/or aspirate at baseline (or archival sample obtained after most recent therapy)...Patients will be assessed every 3 cycles and will receive follow-up for safety for 30–35 days after last dose. Sites are opening in the United States and Europe. Results Not applicable Conclusion Not applicable
  • ||||||||||  INCB57643 / Incyte
    [VIRTUAL] A phase 1 study of INCB057643 monotherapy in patients with relapsed or refractory myelofibrosis (INCB 57643-103) () -  May 12, 2021 - Abstract #BSH2021BSH_330;    
    P1
    Secondary objectives are to evaluate ane- mia response by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leu- kemiaNet Consensus Report (ELN), transfusion dependence, spleen volume, rate and duration of spleen response by IWG-MRT and ELN, and impact on quality of life. Patients will be assessed every 3 cycles and will receive follow-up for safety for 30–35 days after last dose.
  • ||||||||||  INCB57643 / Incyte
    [VIRTUAL] A Phase 1 Study of INCB057643 Monotherapy in Patients with Relapsed or Refractory Myelofibrosis (INCB 57643-103) () -  Mar 11, 2021 - Abstract #AACR2021AACR_3903;    
    P1
    Secondary objectives are to evaluate anemia response by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet Consensus Report (ELN), transfusion dependence, spleen volume, rate and duration of spleen response by IWG-MRT and ELN, and impact on quality of life. Pts will be assessed every 3 cycles and will receive follow-up for safety for 30-35 days after last dose.
  • ||||||||||  INCB57643 / Incyte
    [VIRTUAL] A Phase 1 Study of INCB057643 Monotherapy in Patients with Relapsed or Refractory Myelofibrosis (INCB 57643-103) (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_2630;    
    P1
    Secondary objectives include evaluation of anemia response by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) Consensus Report, red blood cell transfusion dependence, spleen volume, rate of spleen response and duration of spleen response by IWG-MRT and ELN Consensus Report, and impact on quality of life. Patients will be assessed every 3 cycles and will receive follow-up for safety for 30-35 days after last dose of study drug.
  • ||||||||||  epacadostat (INCB024360) / Incyte
    Biomarker, Trial completion date, Trial primary completion date, Combination therapy, Tumor microenvironment, Metastases:  Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206) (clinicaltrials.gov) -  Jul 18, 2019   
    P1/2,  N=70, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Jul 2020 --> Mar 2020 Trial completion date: Oct 2019 --> Jul 2020 | Trial primary completion date: Oct 2019 --> Feb 2019
  • ||||||||||  epacadostat (INCB024360) / Incyte
    Biomarker, Trial completion date, Trial primary completion date, Combination therapy, Tumor microenvironment, Metastases:  Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206) (clinicaltrials.gov) -  Mar 14, 2019   
    P1/2,  N=70, Active, not recruiting, 
    Active, not recruiting --> Terminated; Study terminated due to safety issues. Trial completion date: Oct 2021 --> Oct 2019 | Trial primary completion date: Sep 2021 --> Oct 2019
  • ||||||||||  epacadostat (INCB024360) / Incyte
    Biomarker, Enrollment closed, Enrollment change, Combination therapy, Tumor microenvironment, Metastases:  Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206) (clinicaltrials.gov) -  Jun 6, 2018   
    P1/2,  N=70, Active, not recruiting, 
    Trial completion date: Oct 2021 --> Oct 2019 | Trial primary completion date: Sep 2021 --> Oct 2019 Recruiting --> Active, not recruiting | N=531 --> 70