Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation, With a Substudy

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2020-111
    NCT ID
    • NCT02074839
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I
    Principal Investigator
    • Jay
      Yang, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    The primary objectives of the study are:
    • To assess the safety and tolerability of treatment with AG-120 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle in subjects with advanced hematologic malignancies. The initial dosing regimen was twice daily (approximately every 12 hours). Based on the emerging data, a once daily dosing schedule has been implemented. Alternative dosing schedules, including administration of the same total daily dose using different dosing schedules in concurrent cohorts, may be explored as agreed upon by the Clinical Study Team.

    • To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of AG-120 in subjects with advanced hematologic malignancies.

    • To assess the clinical activity of AG-120 in subjects with R/R AML with an IDH1 mutation who are enrolled in Arm 1 of the expansion phase.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266