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

PHASE1CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

August 12, 2016

Primary Completion Date

October 19, 2017

Study Completion Date

October 19, 2017

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

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

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

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."

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."

Trial Locations (1)

Unknown

Tokyo

Sponsors
All Listed Sponsors
lead

Daiichi Sankyo Co., Ltd.

INDUSTRY