Phase 1 study of DS-3032b in Japanese patients with relapsed or refractory acute myeloid leukemia

Phase 1, open-label, dose escalation study of DS-3032b, an oral MDM2 inhibitor, to assess safety, tolerability and pharmacokinetics in Japanese patients with relapsed or refractory acute myeloid leukemia

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223995

Enrollment

Registered

2018-08-06

Start date

2018-08-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML

Interventions

investigational material(s) Generic name etc : DS-3032b INN of investigational material : Milademetan Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Relapsed or refractory AML - AML for which no standard treatment is available - ECOG Performance Status (PS) of 0 to 2

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
safety Safety and tolerability - The safety of DS-3032b will be assessed by CTCAE. - The maximum tolerated dose of DS-3032b will be estimated.	—

Secondary

Measure	Time frame
efficacy pharmacokinetics - Assessment of pharmacokinetics for DS-3032a (Free form for DS-3032b) - Exploratory assessment of tumor response to DS-3032b - Pharmacokinetics of DS-3032a will be evaluated by following the instruction of the study protocol. - Tumor response will be assessed by the bone marrow findings, and absolute neutrophil count and platelet count in the peripheral blood.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026