Phase I/II study of NS-87 in patients with high risk acute myeloid leukemia.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224810

Enrollment

Registered

2019-07-30

Start date

2019-08-07

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

Acute myeloid leukemia

Interventions

investigational material(s) Generic name etc : NS-87 INN of investigational material : Cytarabine/Daunorubicin Hydrochloride Therapeutic category code : 422 Antimetabolic agents Dosage and Administrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Untreated AML patients diagnosed with therapy-related AML or AML with myelodysplasia-related changes.

Exclusion criteria

Exclusion criteria: Patients with a diagnosis of APL or favorable cytogenetics. Patients with prior treatment intended for induction therapy of AML.

Design outcomes

Primary

Measure	Time frame
safety efficacy pharmacokinetics Phase I part: pharmacokinetics, safety Phase II part: efficacy (remission rate)	—

Secondary

Measure	Time frame
efficacy overall survival	—

Countries

Japan

Contacts

Public ContactClinical Development Operations

Nippon Shinyaku Co., Ltd.

zz_mail_clinical-trials@po.nippon-shinyaku.co.jp+81-120-40-8930

Outcome results

None listed

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