Last updated on June 2018

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)

Brief description of study

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.

Clinical Study Identifier: NCT02078960

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Teva U.S. Medical Information

Teva Investigational Site 87028
Jeonju, Korea, Republic of