Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
A Phase 1 Open-label, Dose-escalation Study Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia
The objectives of this study are to determine the safety and tolerability of ASP2215 as well as the maximum tolerated dose (MTD) based on the onset of dose limiting toxicity (DLT) and/or determine the recommended dose (RD) of ASP2215 for the next phase in subjects with relapsed or treatment-refractory acute myeloid leukemia (AML).
This study will be conducted to determine the safety, tolerability, PK, PD, and efficacy of
single and repeated oral dosing of ASP2215 once daily in patients with relapsed or refractory
AML. After the determination of the MTD and/or RD, an expansion cohort might be set to
further investigate the safety and efficacy of ASP2215.
This study will consist of a single-dose period (Cycle 0, 2 days) and a repeated-dose period
(Cycle 1 and subsequent cycles, each cycle consisting of 28 days). The enrolled subjects will
orally receive their assigned single dose in Cycle 0 (Day −2), followed by a 2-day
observation period (dosing day inclusive). In Cycle 1 and subsequent cycles (one cycle is
defined as 28 days), the subjects will receive oral ASP2215 once daily repeatedly until one
of the discontinuation criteria is met. Another dosing regimen may be considered such as
dosing twice daily based on the safety and PK data that will become available.
In this study, the Bayesian-Continual Reassessment Method (hereinafter, Bayesian-CRM) will be
used as a reference for dose-escalation procedures, and based on the onset of DLTs, the RD
level of the subsequent cohort will be set higher or lower. DLTs will be assessed during
Cycle 0 and Cycle 1 (30 days).
ASP2215 may be escalated by one dose level if the subject meets the criteria at the end of
each cycle after Cycle 1 and the investigator/sub-investigator judges escalation of ASP2215
is of clinical benefit. Dose reduction of ASP2215 will be considered if study drug-related
toxicities are observed in a subject.
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