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Brief Title: A Study of XY0206 Tablets in Patients With Relapsed / Refractory Acute Myeloid Leukemia
Official Title: A Multicenter, Open, Dose Increasing Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Primary Efficacy of xy0206 Tablets in Relapsed / Refractory Acute Myeloid Leukemia Subjects
Study ID: NCT04471064
Brief Summary: 1. To evaluate the safety and tolerability of xy0206 as single drug in the treatment of relapsed / refractory AML; 2. Evaluate the dose limited toxicity (DLT) and maximum tolerable dose (MTD) of xy0206 as single drug in the treatment of relapsed / refractory AML subjects. 3. To evaluate the pharmacokinetic (PK), pharmacokinetic (PD) characteristics and PK / PD correlation of xy0206 as single drug treatment in relapsed / refractory AML subjects; 4. To evaluate the primary efficacy of xy0206 as single drug in the treatment of relapsed / refractory AML patients; 5. To evaluate biomarkers of xy0206 as single drug treatment for relapsed / refractory AML subjects.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin, Tianjin, China
Name: Junyuan Qi, MD
Affiliation: Institute of Hematology, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR