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

NCT04471064 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-05-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Proswell Medical Corporation

    collaborator INDUSTRY

  • Shijiazhuang Yiling Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Junyuan Qi, MD · Institute of Hematology, Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04471064 on ClinicalTrials.gov