Clinical trial · Interventional
Phase 1 Study of Quizartinib
A Phase 1, Open-Label, Dose Escalation Study of Quizartinib, An Oral FLT3 Inhibitor, in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT02675478CI-TRIAL-00037035completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Relapsed AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AC220 | Drug | Quizartinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AC220
- description
- This study will follow a mCRM (modified continual reassessment method) + EWOC (Escalation with Overdose Control) design.
- interventionNames
- Drug: AC220
Primary outcomes (8)
- measure
- number of subjects experiencing adverse events
- timeFrame
- first dose to follow-up, approximately 1 year
- measure
- Cmax of quizartinib and its active metabolite
- timeFrame
- Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
- description
- Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDUsuki K, Handa H, Choi I, Yamauchi T, Iida H, Hata T, Ohwada S, Okudaira N, Nakamura K, Sakajiri S. Safety and pharmacokinetics of quizartinib in Japanese patients with relapsed or refractory acute myeloid leukemia in a phase 1 study. Int J Hematol. 2019 Dec;110(6):654-664. doi: 10.1007/s12185-019-02709-8. Epub 2019 Jul 29. PMID 31359361