Oxidative Phosphorylation Inhibitor IACS-010759 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

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Description

PRIMARY OBJECTIVES: I. Safety and tolerability. II. Determine dose limiting toxicities (DLTs). III. Establish maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). SECONDARY OBJECTIVES: I. Oxidative phosphorylation inhibitor IACS-010759 (IACS-010759) pharmacokinetics and food effect. II....

PRIMARY OBJECTIVES: I. Safety and tolerability. II. Determine dose limiting toxicities (DLTs). III. Establish maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). SECONDARY OBJECTIVES: I. Oxidative phosphorylation inhibitor IACS-010759 (IACS-010759) pharmacokinetics and food effect. II. Preliminary clinical efficacy (overall response rates, duration of response, progression-free survival, overall survival). EXPLORATORY OBJECTIVES: I. Pharmacodynamic and exploratory biomarkers of activity of IACS-010759. OUTLINE: This is a dose-escalation study. INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 orally (PO) once daily (QD) on days 1-7. MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor. After completion of study treatment, patients are followed up every 3-6 months for up to 5 years.

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