drugset / Trial / NCT02181660

Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT02181660

Phase 1 Completed 24 enrolled Astellas Pharma Inc
NaSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2014-06-16
Primary completion
2016-06-27
Completion
2016-06-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Gilteritinib Small molecule Oral