NCT03723681

Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

A Study to Evaluate the Safety and Pharmacokinetics of Quizartinib in Combination With Standard Induction Therapy and Consolidation Therapy in Chinese Patients With Newly Diagnosed Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

20 mg or 40 mg of quizartinib will be given to Chinese patients who were just diagnosed with AML. The study drug will be given to them along with standard therapies. The purpose is to find out the highest dose they can stand.

Detailed description

This is a Phase 1, multicenter, open-label study to evaluate the safety and pharmacokinetics (PK) of quizartinib in combination with standard induction therapy and consolidation therapy in Chinese patients with newly diagnosed AML. The quizartinib doses will be Level 1: 20 mg and Level 2: 40 mg. No increase in the quizartinib dose will be made in the same subject. Dose-limiting toxicity associated with quizartinib occurring at each level will be assessed, and the maximum tolerated dose (MTD) will be decided using a 3 + 3 design.

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Quizartinib	Quizartinib is provided as 20 mg tablets for oral administration

Timeline

• Start date: 2018-11-05
• Primary completion: 2022-03-03
• Completion: 2022-03-03
• First posted: 2018-10-29
• Last updated: 2022-07-29

Locations

1 site across 1 country: China