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

• Status: Completed
• Trial end date: 2019-09-06
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Criteria

Inclusion Criteria:

• Relapsed or refractory AML

• AML for which no standard treatment is available

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

Exclusion Criteria:

• Acute Promyelocytic Leukemia

• Chronic myelogenous leukemia in blast crisis (BCR-ABL fusion gene positive)

• Presence of central nervous system involvement of leukemia or a history of primary central nervous system leukemia