Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
- Registration Number
- NCT03723681
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Quizartinib 20 mg Quizartinib Participants receive 20 mg quizartinib in combination with standard induction therapy and consolidation therapy once daily in the fasted state in the morning (at least 1 hour before or two hours after a meal) Quizartinib 40 mg Quizartinib Participants receive 40 mg quizartinib in combination with standard induction therapy and consolidation therapy once daily in the fasted state in the morning (at least 1 hour before or two hours after a meal)
- Primary Outcome Measures
Name Time Method Maximum Concentration (Cmax) within 56 days Categories: quizartinib, active metabolite
Number of Participants with Dose-Limiting Toxicities At the end of induction phase at approximately 56 days Number of Participants with Adverse Events During the Trial within approximately 19 months Time to Cmax (Tmax) within 56 days Categories: quizartinib, active metabolite
Area under the Plasma Concentration-Time Curve (AUC) within 56 days Categories: quizartinib, active metabolite
- Secondary Outcome Measures
Name Time Method Number of Participants with Response within approximately 19 months Categories: Complete remission (CR), CR with incomplete platelet or hematological recovery (CRi), partial remission (PR), no response (NR)
Response Rates within approximately 19 months Categories: response rate (CRc + PR), composite CR (CRc: CR + CRi) rate
Trial Locations
- Locations (1)
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
🇨🇳Tianjin, China