NCT02834390

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-08-12
• Primary completion: 2017-10-19
• Completion: 2017-10-19
• First posted: 2016-07-15
• Last updated: 2025-03-05
• Results posted: 2021-08-19

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study