Phase 1 Study of Quizartinib

Daiichi Sankyo

Status and phase: Completed; Phase 1

Conditions: Relapsed AML; Refractory AML

Treatments: Drug: AC220

Study type: Interventional

Funder types: Industry

Identifiers

NCT02675478

AC220-A-J101

Details and patient eligibility

About

This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.

Enrollment: 17 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Acute Promyelocytic Leukemia
• chronic myelogenous leukemia in blast phase (BCR-ABL fusion gene positive)
• History of other malignancies within 3 years prior to enrollment, except curatively treated in-situ carcinoma, AML, or MDS.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

AC220

Experimental group

Description:

This study will follow a mCRM (modified continual reassessment method) + EWOC (Escalation with Overdose Control) design.

Treatment:

Drug: AC220