Clinical trial

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

Name

DS3032-A-J104

Description

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).

Trial arms

Trial start

2018-08-23

Estimated PCD

2019-09-11

Trial end

2019-09-11

Status

Completed

Phase

Early phase I

Treatment

Milademetan

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

Arms:

Milademetan (120 mg/Day), Milademetan (160 mg/Day), Milademetan (90 mg/Day)

Other names:

DS-3032b

Size

Primary endpoint

Number of Participants With Dose Limiting Toxicities (DLTs) Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia

First 28 Days of Cycle 1

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Following Administration of Milademetan in Participants With Relapsed or Refractory Acute Myeloid Leukemia

From date of signing of informed consent form up to 30 days after last dose of study drug, up to 1 year

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}

Updated at

2023-11-07

1 organization

1 product

1 indication

Organization

Daiichi Sankyo

Product

Milademetan

Indication

Acute Myeloid Leukemia