NCT03671564

Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Milademetan	Milademetan was administered orally once daily on Days 1 to 14 in a 28-day cycle.

Timeline

• Start date: 2018-08-23
• Primary completion: 2019-09-11
• Completion: 2019-09-11
• First posted: 2018-09-14
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

8 sites across 1 country: Japan