Phase 1b study of quizartinib

Phase 1b, open-Label, dose escalation study of quizartinib in combination with induction and consolidation chemotherapy in Japanese patients with newly diagnosed acute myeloid leukemia (AML)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223254

Enrollment

Registered

2016-06-30

Start date

2016-08-12

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

Newly diagnosed AML

Interventions

investigational material(s) Generic name etc : AC220 INN of investigational material : Quizartinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -No prior treatment for AML (including quizartinib) -ECOG Performance Status (PS) of 0 to 2

Exclusion criteria

Exclusion criteria: -Diagnosis of acute promyelocytic leukemia -Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy

Design outcomes

Primary

Measure	Time frame
safety pharmacokinetics Safety, tolerability, and pharmacokinetics -The safety of quizartinib administered in combination with induction and consolidation chemotherapy will be assessed by CTCAE. -The maximum tolerated dose of quizartinib, and the recommended dose of quizartinib in combination with induction and consolidation chemotherapy for the following clinical studies will be estimated.	—

Secondary

Measure	Time frame
efficacy other -Exploratory assessment of quizartinib-related biomarkers -Exploratory assessment of tumor response to quizartinib -Biomarker analyses will be conducted using the bone marrow aspirate specimen and blood samples. -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