20 and older, any sex, with Leukemia, Myeloid, Acute. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Composite Complete Remission (CRc) Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLPrimary· Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation
The composite complete remission (CRc) rate is defined as the proportion of participants whose best response is complete remission \[CR\], CR with incomplete platelet recovery \[CRp\], or CR with incomplete hematological recovery \[CRi\]) after treatment with quizartinib.
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
56.5
37.5 – 74.2
Initial Dose 20 mg/Day Quizartinib
33.3
1.7 – 86.5
Total
53.8
36.2 – 70.8
Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLSecondary· Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML
Best response is defined as the best measured response over all response assessments (complete response \[CR\], CR with incomplete platelet recovery \[CRp\], CR with incomplete hematological recovery \[CRi\], partial remission \[PR\], no response \[NR\], or Unknown) at all time points after the first dose of the study drug to the end of treatment (does not include response from any subsequent AML therapy including transplantation).
Complete response (CR)
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
0
Initial Dose 20 mg/Day Quizartinib
0
Total
0
Complete response with incomplete platelet (CRp)
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
1
Initial Dose 20 mg/Day Quizartinib
0
Total
1
Complete response with incomplete hematologic(CRi)
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
12
Initial Dose 20 mg/Day Quizartinib
1
Total
13
Partial remission (PR)
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
6
Initial Dose 20 mg/Day Quizartinib
1
Total
7
No response (NR)
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
5
Initial Dose 20 mg/Day Quizartinib
1
Total
6
Response Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLSecondary· Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
79.2
57.8 – 92.9
Initial Dose 20 mg/Day Quizartinib
66.7
9.4 – 99.2
Total
77.8
57.7 – 91.4
Duration of Composite Complete Remission (CRc) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLSecondary· Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation
Duration from the date of first composite complete remission (CRc) (complete remission \[CR\], CR with incomplete platelet recovery \[CRp\], or CR with incomplete hematological recovery \[CRi\]) observed to the date of documented relapse was assessed.
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
16.1
4.7 – 24.6
Initial Dose 20 mg/Day Quizartinib
NA
NA – NA
Total
16.1
4.7 – 24.6
Overall Survival (OS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLSecondary· Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 1 year
OS is defined as the time from registration (enrollment) until death from any cause.
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
34.1
27.1 – NA
Initial Dose 20 mg/Day Quizartinib
NA
22.6 – NA
Total
34.1
27.1 – NA
Event-free Survival (EFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLSecondary· Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 32 weeks
Event-free survival is defined as the time from date of registration until documented refractory disease, relapse after response of composite complete remission (CRc = complete remission \[CR\], CR with incomplete platelet recovery \[CRp\], or CR with incomplete hematological recovery \[CRi\]), or death from any cause, whichever occurs first.
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
12.7
0.1 – 24.7
Initial Dose 20 mg/Day Quizartinib
0.1
0.1 – NA
Total
12.7
0.1 – 24.7
Leukemia-free Survival (LFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLSecondary· Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 28 weeks
Leukemia-free survival (LFS) is the time from the first documented response of CRc until documented relapse or death from any cause. The analysis for LFS will be conditional on the participant having a documented best response of CRc.
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
16.1
4.7 – 24.6
Initial Dose 20 mg/Day Quizartinib
NA
NA – NA
Total
16.1
4.7 – 24.6
Hematopoietic Stem Cell Transplantation Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLSecondary· Up to new AML treatment or 1 year post treatment
Proportion of participants who start hematopoietic stem cell transplantation (HSCT) immediately after the end of treatment with the study drug without receiving other treatment for AML, except for conditioning regiment for HSCT, was assessed.
Group
Value
95% CI
Initial Dose 30 mg/Day Quizartinib
37.9
20.7 – 57.7
Initial Dose 20 mg/Day Quizartinib
33.3
0.8 – 90.6
Total
37.5
21.1 – 56.3
Change in the Area Under the Plasma Concentration Time Curve (AUC) of Quizartinib and Its Active Metabolite After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLSecondary· Cycle 1, Days 1 and 15; Cycle 2, Day 1
Cycle 1, Day 1; Quizartinib (n=3,34,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
877
± 489
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
1170
± 716
Cycle 1, Day 1; Active Metabolite (n=3,34,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
75.1
± 80.6
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
560
± 391
Cycle 1, Day 15; Quizartinib (n=3,32,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
2610
± 693
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
3970
± 2610
Cycle 1, Day 15; Active Metabolite (n=3,32,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
430
± 276
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
3120
± 1300
Cycle 2, Day 1; Quizartinib (n=0,0,2,21)
Group
Value
95% CI
Quizartinib 30 mg/Day (With Use of Strong CYP3A4 Inhibitor)
2960
± 749
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
9240
± 6090
Cycle 2, Day 1; Active Metabolite (n=0,0,2,21)
Group
Value
95% CI
Quizartinib 30 mg/Day (With Use of Strong CYP3A4 Inhibitor)
983
± 389
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
6530
± 2630
Change in the Maximum Plasma Concentration (Cmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLSecondary· Cycle 1, Days 1 and 15; Cycle 2, Day 1
Cycle 1, Day 1; Quizartinib (n=3,34,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
48.1
± 25.9
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
76.9
± 46.8
Cycle 1, Day 1; Active Metabolite (n=3,34,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
3.92
± 4.49
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
29.1
± 20.9
Cycle 1, Day 15; Quizartinib (n=3,32,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
127
± 35.9
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
211
± 132
Cycle 1, Day 15; Active Metabolite (n=3,32,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
18.9
± 12.1
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
146
± 60.4
Cycle 2, Day 1; Quizartinib (n=0,0,2,21)
Group
Value
95% CI
Quizartinib 30 mg/Day (With Use of Strong CYP3A4 Inhibitor)
149
± 38.2
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
480
± 296
Cycle 2, Day 1; Active Metabolite (n=0,0,2,21)
Group
Value
95% CI
Quizartinib 30 mg/Day (With Use of Strong CYP3A4 Inhibitor)
43.7
± 17.7
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
298
± 118
Change in the Trough Plasma Concentration (Ctrough) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLSecondary· Cycle 1, Day 15
Cycle 1, Day 15; Quizartinib
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
98.2
± 19.7
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
128
± 92.5
Cycle 1, Day 15; Active Metabolite
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
17.8
± 11.3
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
112
± 47.9
Change in the Time to Reach Maximum Plasma Concentration (Tmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AMLSecondary· Cycle 1, Days 1 and 15; Cycle 2, Day 1
Cycle 1, Day 1; Quizartinib (n=3,34,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
4.08
2.17 – 6.17
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
4.03
1.85 – 24.20
Cycle 1, Day 1; Active Metabolite (n=2,33,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
24.33
24.25 – 24.42
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
24.32
3.93 – 24.67
Cycle 1, Day 15; Quizartinib (n=3,32,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
4.08
4.08 – 6.25
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
3.06
1.42 – 6.08
Cycle 1, Day 15; Active Metabolite (n=3,32,0,0)
Group
Value
95% CI
Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)
4.08
0 – 6.25
Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
5.82
0.83 – 24.50
Cycle 2, Day 1; Quizartinib (n=0,0,2,21)
Group
Value
95% CI
Quizartinib 30 mg/Day (With Use of Strong CYP3A4 Inhibitor)
6.17
6.08 – 6.24
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
3.87
0 – 6.23
Cycle 2, Day 1; Active Metabolite (n=0,0,2,21)
Group
Value
95% CI
Quizartinib 30 mg/Day (With Use of Strong CYP3A4 Inhibitor)
14.17
4.25 – 24.08
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
5.65
0 – 24.02
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 2, multi-center, open-label study to evaluate the efficacy, safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD positive refractory or relapsed acute myeloid leukemia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06769490 — Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia
· Phase 1
· recruiting
NCT06578247 — Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
· Phase 3
· recruiting
NCT06740825 — Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects
· Phase 1
· completed
NCT06772246 — A Study to Evaluate QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate
· Phase 1
· completed
NCT06740799 — Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
· Phase 1
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo Co., Ltd.
Last refreshed: 17 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02984995.