Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Status:
Completed
Trial end date:
2019-09-06
Target enrollment:
Participant gender:
Summary
This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and
pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute
myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the
milademetan dose will be made in the same participant. Dose-limiting toxicity associated with
milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD)
will be decided using a modified continuous reassessment method (mCRM).