Clinical Trial: A Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase (CP) or Accelerated Phase (AP) Chronic Myeloid Leukemia (CML) (Referred to as the SYNSINCT Study)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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Official Title: An Open-Label, Single-Group Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Omacetaxine Mepesuccinate Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase or

Brief Summary: To satisfy a postmarketing requirement, the sponsor has been requested to conduct a Phase 1/Phase 2 single-group clinical study to investigate the pharmacokinetics and preliminary safety and efficacy of omacetaxine following a fixed-dose administration to patients with CP or AP CML who have failed 2 or more tyrosine kinase inhibitor (TKI) therapies.