At a glance
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Phase 1, Open-label, Dose Escalation Study of Milademetan, an Oral MDM2 Inhibitor, to Assess Safety, Tolerability and Pharmacokinetics in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia
In Brief
A Phase 1 clinical trial evaluating Milademetan for Acute Myeloid Leukemia. Completed, enrolled 14 participants across 8 sites.
Detailed 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).
Study Details
Timeline
Interventions
Milademetan was administered orally once daily on Days 1 to 14 in a 28-day cycle.