NCT04471064

A Study of XY0206 Tablets in Patients With Relapsed / Refractory Acute Myeloid Leukemia

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	XY0206	Dosage form:Tablet;Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the withdrawal criteria. The duration and interval of treatment were determined according to the accumulated condition after multiple dose.

Timeline

• Start date: 2020-09-15
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2020-07-14
• Last updated: 2023-05-18

Locations

1 site across 1 country: China