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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Quizartinib is provided as 20 mg tablets for oral administration
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
Number of Participants with Dose-Limiting Toxicities
Time frame: At the end of induction phase at approximately 56 days
Number of Participants with Adverse Events During the Trial
Time frame: within approximately 19 months
Maximum Concentration (Cmax)
Categories: quizartinib, active metabolite
Time frame: within 56 days
Time to Cmax (Tmax)
Categories: quizartinib, active metabolite
Time frame: within 56 days
Area under the Plasma Concentration-Time Curve (AUC)
Categories: quizartinib, active metabolite
Time frame: within 56 days
Number of Participants with Response
Categories: Complete remission (CR), CR with incomplete platelet or hematological recovery (CRi), partial remission (PR), no response (NR)
Time frame: within approximately 19 months
Response Rates
Categories: response rate (CRc + PR), composite CR (CRc: CR + CRi) rate
Time frame: within approximately 19 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.