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

Ход выполнения

Заболевания

Дата начала КИ

23.08.2018

Дата окончания КИ

11.09.2019

Организация, проводящая КИ

Daiichi Sankyo, Inc.

Фаза КИ

I

Цель КИ

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).

Количество пациентов

14

Источник