Acute Myeloid LeukemiaPhase 1NCT02834390

Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

A Phase 1 study testing Quizartinib, Cytarabine and Idarubicin in people with Acute Myeloid Leukemia, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of the combination of quizartinib and induction and consolidation chemotherapy. Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Acute Myeloid Leukemia
What is being tested?: Quizartinib, Cytarabine and Idarubicin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteJapan
Study dates: 12 Aug 2016to 19 Oct 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

No prior treatment for AML (including quizartinib)
ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 2

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Tokyo

Other trials in Japan

About this study

Official title: 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)

Conditions: Acute Myeloid Leukemia
Being tested: Quizartinib, Cytarabine, Idarubicin, Daunorubicin
Keywords: AML, phase 1, hematology, malignancy, newly diagnosed
Medical subject headings: Leukemia, Myeloid, Acute, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuizartinibDrug
[Induction period, Cycle 1] Once-daily repeated oral administration Day 8 to Day 21.
[Induction period, Cycle 2] Once-daily repeated oral administration Day 6 to Day 19.
[Consolidation period] Once-daily repeated oral administration Day 6 to Day 19.
CytarabineDrug
[Induction period, Cycle 1] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 7.
[Induction period, Cycle 2] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 5.
[Consolidation period] Twice-daily intravenous injection of 3.0 g/m^2 cytarabine at 12-hour intervals on Days 1, 3, and 5.
IdarubicinDrug
Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 to 3.
[Induction period, Cycle 2] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 and 2.
DaunorubicinDrug
Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 to 3.
[Induction period, Cycle 2] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 and 2.

Study groups in NCT02834390
Study group	Role	What they receive
Quizartinib 20 mg/day	Experimental	Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. Receives: Drug: Quizartinib; Drug: Cytarabine; Drug: Idarubicin; Drug: Daunorubicin
Quizartinib 40 mg/day	Experimental	Participants who received 40 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. Receives: Drug: Quizartinib; Drug: Cytarabine; Drug: Idarubicin; Drug: Daunorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose. CR is defined as absence of leukemia cells morphologically; bone marrow blasts <5 %; neutrophil count ≥ 1000 /mm 3; platelet count ≥ 100 ,000 /mm 3, independence of RBC transfusions for 4 weeks; independence of platelet transfusions for 1 week; absence of extramedullary leukemia.
Measured: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year
Summary of Best Response Rates After the First Oral Dose of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia
Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose.
Measured: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia
The maximum serum plasma concentration (Cmax) is reported at Induction phase Cycle 1, Day 9 and the maximum serum plasma concentration at steady state (Cmax,ss) is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886.
Measured: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)
Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia
The area under the plasma concentration-time curve during dosing interval (AUCtau) of geometric means is reported at Induction phase Cycle 1, Day 9 and the area under the plasma concentration-time curve during dosing interval at steady state (AUCtauss) of geometric means are reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886.
Measured: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
The time of maximum plasma concentration (Tmax) of geometric means is reported at Induction phase Cycle 1, Day 9 and the time of maximum plasma concentration at steady state (Tmax,ss) of geometric means is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886.
Measured: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)
Pharmacokinetic Parameter Metabolite to Parent Ratio (MR) of Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
The metabolite to parent ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 9 for active metabolite AC886 is reported.
Measured: Induction phase Cycle 1, Day 8 (each cycle 28 days)
Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
The trough plasma concentration (Ctrough) of geometric means is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886.
Measured: Induction phase Cycle 1, Day 21 (each cycle 28 days)
Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
The accumulation ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886.
Measured: Induction phase Cycle 1, Day 21 (each cycle 28 days)
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier.
Measured: Induction phase Cycle 1, Day 1 up to 35 days after last dose in Cycle 2 (each cycle 28 days), up to approximately 1 year
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier.
Measured: Consolidation phase Cycle 1, Day 1 up to 35 days after last dose (each cycle 28 days), up to approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 201619 Oct 2017

First posted15 Jul 2016 (estimated)
Study start12 Aug 2016
Primary completion19 Oct 2017
Study completion19 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02834390
Sponsor's protocol ID: AC220-A-J102
Status last verified: Feb 2025
First submitted: 13 Jul 2016
Last updated: 5 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
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RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02834390
Acronym / sponsor ID: AC220-A-J102
Conditions: Acute Myeloid Leukemia
Keywords: AML, phase 1, hematology, malignancy, newly diagnosed
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
Study start: 12 Aug 2016 (actual)
Primary completion: 19 Oct 2017 (actual)
Study completion: 19 Oct 2017 (actual)
First posted: 15 Jul 2016 (estimated)
Results: Posted 19 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Quizartinib 20 mg/day	Experimental	Drug: Quizartinib, Drug: Cytarabine, Drug: Idarubicin, Drug: DaunorubicinParticipants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib.
Quizartinib 40 mg/day	Experimental	Drug: Quizartinib, Drug: Cytarabine, Drug: Idarubicin, Drug: DaunorubicinParticipants who received 40 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib.

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

No prior treatment for AML (including quizartinib)
ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 2

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quizartinib[Induction period, Cycle 1] Once-daily repeated oral administration Day 8 to Day 21. [Induction period, Cycle 2] Once-daily repeated oral administration Day 6 to Day 19. [Consolidation period] Once-daily repeated oral administration Day 6 to Day 19.	Drug	Quizartinib 20 mg/day, Quizartinib 40 mg/day
Cytarabine[Induction period, Cycle 1] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 7. [Induction period, Cycle 2] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 5. [Consolidation period] Twice-daily intravenous injection of 3.0 g/m^2 cytarabine at 12-hour intervals on Days 1, 3, and 5.	Drug	Quizartinib 20 mg/day, Quizartinib 40 mg/day
IdarubicinEither Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 to 3. [Induction period, Cycle 2] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 and 2.	Drug	Quizartinib 20 mg/day, Quizartinib 40 mg/day
DaunorubicinEither Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 to 3. [Induction period, Cycle 2] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 and 2.	Drug	Quizartinib 20 mg/day, Quizartinib 40 mg/day

Primary outcome

Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
Time frame: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year
Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose. CR is defined as absence of leukemia cells morphologically; bone marrow blasts <5 %; neutrophil count ≥ 1000 /mm 3; platelet count ≥ 100 ,000 /mm 3, independence of RBC transfusions for 4 weeks; independence of platelet transfusions for 1 week; absence of extramedullary leukemia.
Summary of Best Response Rates After the First Oral Dose of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia
Time frame: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year
Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose.
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia
Time frame: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)
The maximum serum plasma concentration (Cmax) is reported at Induction phase Cycle 1, Day 9 and the maximum serum plasma concentration at steady state (Cmax,ss) is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886.
Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia
Time frame: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)
The area under the plasma concentration-time curve during dosing interval (AUCtau) of geometric means is reported at Induction phase Cycle 1, Day 9 and the area under the plasma concentration-time curve during dosing interval at steady state (AUCtauss) of geometric means are reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886.
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Time frame: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)
The time of maximum plasma concentration (Tmax) of geometric means is reported at Induction phase Cycle 1, Day 9 and the time of maximum plasma concentration at steady state (Tmax,ss) of geometric means is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886.
Pharmacokinetic Parameter Metabolite to Parent Ratio (MR) of Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Time frame: Induction phase Cycle 1, Day 8 (each cycle 28 days)
The metabolite to parent ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 9 for active metabolite AC886 is reported.
Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Time frame: Induction phase Cycle 1, Day 21 (each cycle 28 days)
The trough plasma concentration (Ctrough) of geometric means is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886.
Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Time frame: Induction phase Cycle 1, Day 21 (each cycle 28 days)
The accumulation ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886.
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Time frame: Induction phase Cycle 1, Day 1 up to 35 days after last dose in Cycle 2 (each cycle 28 days), up to approximately 1 year
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier.
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Time frame: Consolidation phase Cycle 1, Day 1 up to 35 days after last dose (each cycle 28 days), up to approximately 1 year
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier.

Results and safety

Results posted to the registry on 19 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Quizartinib 20 mg/Day	4	2
Quizartinib 40 mg/Day	3	1

Primary outcome: Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Time frame: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year. Count of participants. Unit: Participants

Measure	Quizartinib 20 mg/Day n = 4	Quizartinib 40 mg/Day n = 3
Complete remission (CR)	0	0
CR with incomplete platelet recovery (CRp)	0	0
CR with incomplete hematological recovery (CRi)	3	2
Partial remission (PR)	1	0
No response (NR)	0	1

Population analysed: Best response was assessed in the Efficacy Analysis Set.

Primary outcome: Summary of Best Response Rates After the First Oral Dose of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia

Time frame: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Quizartinib 20 mg/Day n = 4	Quizartinib 40 mg/Day n = 3
Composite CR rate (CRc rate: CR+CRp+CRi)	75.0 (30.1 to 95.4)	66.7 (20.8 to 93.9)
Response rate (CRc+PR)	100 (51.0 to 100.0)	66.7 (20.8 to 93.9)

Population analysed: Best response was assessed in the Efficacy Analysis Set.

Primary outcome: Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia

Time frame: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Quizartinib 20 mg/Day n = 4	Quizartinib 40 mg/Day n = 3
Cycle 1, Day 8: Quizartinib, Cmax	42.4 (25.7)	91.3 (28.5)
Cycle 1, Day 8: AC886, Cmax	36.5 (25.4)	103 (37.0)
Cycle 1, Day 8: Quizartinib + AC886, Cmax	77.4 (10.3)	180 (16.0)
Cycle 1, Day 21: Quizartinib, Cmax, ss	64.2 (64.0)	212 (47.4)
Cycle 1, Day 21: AC886, Cmax, ss	96.7 (23.7)	256 (45.0)
Cycle 1, Day 21: Quizartinib + AC886, Cmax	162 (35.3)	480 (2.4)

Population analysed: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Primary outcome: Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia

Time frame: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days). Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Quizartinib 20 mg/Day n = 4	Quizartinib 40 mg/Day n = 3
Cycle 1, Day 8: Quizartinib, AUCtau	418 (50.4)	921 (31.3)
Cycle 1, Day 8: AC886, AUCtau	555 (28.8)	1640 (24.4)
Cycle 1, Day 8: Quizartinib + AC886, AUCtau	1010 (26.9)	2640 (8.0)
Cycle 1, Day 21: Quizartinib, AUCtau,ss	991 (87.7)	2940 (76.6)
Cycle 1, Day 21: AC886, AUCtau, ss	1940 (25.4)	5310 (40.6)
Cycle 1, Day 21: Quizartinib + AC886, AUCtau	3020 (42.3)	8850 (0.3)

Population analysed: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Adverse events

Time frame: Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Quizartinib 20 mg/Day	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Quizartinib 40 mg/Day	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

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Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Leader study director

Daiichi Sankyo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Quizartinib, Cytarabine and Idarubicin in people with Acute Myeloid Leukemia, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) (time frame: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02834390.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.