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    DRUG:

    Vanflyta (quizartinib)

    i
    Company:
    Daiichi Sankyo
    Drug class:
    FLT3 inhibitor
    Related drugs:
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    Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (NCI-2018-01789) (NCT03661307)
    Phase 1/2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    10/31/2018
    Primary completion :
    01/01/2026
    Completion :
    01/01/2026
    TP53 • FLT3
    |
    TP53 mutation • FLT3-ITD mutation • FLT3 mutation • TP53 deletion
    |
    Venclexta (venetoclax) • azacitidine • Vanflyta (quizartinib) • decitabine
    Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations (NCI-2020-05261) (NCT04493138)
    Phase 1/2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    05/30/2024
    Initiation :
    07/21/2020
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    TP53 • FLT3 • ASXL1
    |
    TP53 mutation • FLT3-ITD mutation • ASXL1 mutation • CBL mutation
    |
    azacitidine • Vanflyta (quizartinib)
    Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (NCI-2018-01813) (NCT01892371)
    Phase 1/2
    M.D. Anderson Cancer Center
    Completed
    Last update posted :
    02/28/2024
    Initiation :
    11/12/2013
    Primary completion :
    02/07/2023
    Completion :
    02/07/2023
    FLT3
    |
    FLT3 mutation
    |
    cytarabine • azacitidine • Vanflyta (quizartinib) • Starasid (cytarabine ocfosfate)
    Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood (NCT03793478)
    Phase 1/2
    Daiichi Sankyo, Inc.
    Recruiting
    Last update posted :
    12/11/2023
    Initiation :
    08/15/2018
    Primary completion :
    05/01/2027
    Completion :
    05/01/2027
    FLT3
    |
    FLT3-ITD mutation
    |
    cytarabine • etoposide IV • Vanflyta (quizartinib) • fludarabine IV
    Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) (QuANTUM-First) (NCT02668653)
    Phase 3
    Daiichi Sankyo, Inc.
    Completed
    Last update posted :
    11/20/2023
    Initiation :
    09/01/2016
    Primary completion :
    08/13/2021
    Completion :
    06/16/2023
    FLT3
    |
    FLT3-ITD mutation
    |
    cytarabine • Vanflyta (quizartinib) • daunorubicin • idarubicin hydrochloride
    Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia (NCT03735875)
    Phase 1/2
    M.D. Anderson Cancer Center
    Completed
    Last update posted :
    10/16/2023
    Initiation :
    01/25/2019
    Primary completion :
    07/26/2023
    Completion :
    07/26/2023
    FLT3 • BCL2
    |
    FLT3-ITD mutation
    |
    Venclexta (venetoclax) • Vanflyta (quizartinib)
    Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or Azacitidine Plus Venetoclax and Quizartinib in Newly Diagnosed AML Patients Aged Equal or More Than 60 Years Old (VEN-A-QUI) (NCT04687761)
    Phase 1/2
    PETHEMA Foundation
    Recruiting
    Last update posted :
    09/08/2022
    Initiation :
    11/04/2020
    Primary completion :
    11/01/2024
    Completion :
    11/01/2024
    IDH1 • IDH2 • NPM1
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • Vanflyta (quizartinib)
    Daunorubicin or Idarubicin With Cytarabine Plus Quizartinib vs Physician's Choice in Newly Diagnosed FLT3-ITD+ AML (Q-SOC) (NCT04676243)
    Phase 3
    University Hospital Heidelberg
    Withdrawn
    Last update posted :
    05/25/2022
    Initiation :
    05/01/2022
    Primary completion :
    05/01/2025
    Completion :
    12/01/2025
    FLT3
    |
    FLT3-ITD mutation • FLT3 wild-type
    |
    cytarabine • midostaurin • Vanflyta (quizartinib) • daunorubicin • idarubicin hydrochloride
    AC220 for Children With Relapsed/Refractory ALL or AML (NCT01411267)
    Phase 1
    Therapeutic Advances in Childhood Leukemia Cons...
    Completed
    Last update posted :
    04/04/2022
    Initiation :
    09/01/2011
    Primary completion :
    09/12/2013
    Completion :
    09/12/2013
    FLT3 • KMT2A
    |
    MLL rearrangement
    |
    cytarabine • etoposide IV • Vanflyta (quizartinib) • methotrexate
    (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive (NCT02039726)
    Phase 3
    Daiichi Sankyo, Inc.
    Completed
    Last update posted :
    02/24/2021
    Initiation :
    05/01/2014
    Primary completion :
    02/22/2018
    Completion :
    09/08/2020
    FLT3
    |
    FLT3-ITD mutation
    |
    cytarabine • Vanflyta (quizartinib)
    Expanded Treatment Protocol for Adults With FLT3-ITD Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) to Receive Quizartinib (NCT03746912)
    Phase N/A
    Daiichi Sankyo, Inc.
    No Longer Available
    Last update posted :
    04/15/2020
    FLT3
    |
    FLT3-ITD mutation
    |
    Vanflyta (quizartinib)
    Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation (NCT02984995)
    Phase 2
    Daiichi Sankyo Co., Ltd.
    Completed
    Last update posted :
    02/17/2020
    Initiation :
    12/08/2016
    Primary completion :
    03/28/2018
    Completion :
    09/14/2018
    FLT3
    |
    FLT3-ITD mutation
    |
    Vanflyta (quizartinib)
    Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT01565668)
    Phase 2
    Daiichi Sankyo, Inc.
    Completed
    Last update posted :
    12/27/2019
    Initiation :
    04/01/2012
    Primary completion :
    03/01/2015
    Completion :
    03/01/2015
    FLT3
    |
    FLT3-ITD mutation
    |
    Vanflyta (quizartinib)
    A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML) (NCT01390337)
    Phase 1
    Daiichi Sankyo, Inc.
    Completed
    Last update posted :
    02/12/2019
    Initiation :
    10/01/2011
    Primary completion :
    02/01/2015
    Completion :
    02/01/2015
    FLT3 • MPO
    |
    FLT3-ITD mutation
    |
    cytarabine • Vanflyta (quizartinib) • daunorubicin
    Dose Finding, Safety and Tolerability Study for AC220 to Treat Advanced Solid Tumors (NCT01049893)
    Phase 1
    Daiichi Sankyo, Inc.
    Completed
    Last update posted :
    02/12/2019
    Initiation :
    01/01/2010
    Primary completion :
    11/01/2011
    Completion :
    11/01/2011
    KIT
    |
    Vanflyta (quizartinib)
    Phase 1 Study of Quizartinib (NCT02675478)
    Phase 1
    Daiichi Sankyo Co., Ltd.
    Completed
    Last update posted :
    02/12/2019
    Initiation :
    02/01/2016
    Primary completion :
    11/13/2018
    Completion :
    11/13/2018
    FLT3
    |
    Vanflyta (quizartinib)
    A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia (AML) (NCT01468467)
    Phase 1
    Daiichi Sankyo, Inc.
    Completed
    Last update posted :
    02/12/2019
    Initiation :
    04/01/2012
    Primary completion :
    03/01/2015
    Completion :
    03/01/2015
    HLA-DRB1 • HLA-DQB1 • HLA-B • HLA-C
    |
    Vanflyta (quizartinib)