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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-12

Study Completion Date

2017-10-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quizartinib 20 mg/day

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.

Group Type EXPERIMENTAL

Quizartinib

Intervention Type DRUG

\[Induction period, Cycle 1\] 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.

Cytarabine

Intervention Type DRUG

\[Induction period, Cycle 1\] 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.

Idarubicin

Intervention Type DRUG

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.

Daunorubicin

Intervention Type DRUG

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.

Quizartinib 40 mg/day

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.

Group Type EXPERIMENTAL

Quizartinib

Intervention Type DRUG

\[Induction period, Cycle 1\] 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.

Cytarabine

Intervention Type DRUG

\[Induction period, Cycle 1\] 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.

Idarubicin

Intervention Type DRUG

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.

Daunorubicin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Idarubicin

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.

Intervention Type DRUG

Daunorubicin

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No