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

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.

Detailed Summary:
Sponsor: Teva Branded Pharmaceutical Products, R&D Inc.

Current Primary Outcome:

  • Proportion of participants with Chronic Phase Chronic Myeloid Leukemia (CP CML) who achieve a major cytogenetic response (MCyR) [ Time Frame: 12 Months ]
  • Proportion of participants with Accelerated Phase (AP) CML who achieve a major hematologic response and/or MCyR. [ Time Frame: 12 Months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of response [ Time Frame: 12 months ]
    Time interval from the first reported date of MCyR or major hematologic response (MaHR) to the earliest date of objective evidence of disease progression
  • Ratio of BCR-ABL transcript numbers to the number of control gene transcripts [ Time Frame: 12 Months ]
    Molecular response by site (peripheral transcript of the gene protein BCR-ABL)
  • Progression-free survival [ Time Frame: 24 Months ]
    Defined as the time interval from date of first dose to earliest date of objective evidence of disease progression
  • Overall survival [ Time Frame: 24 Months ]
    Defined as the time interval from date of first dose to date of death from any cause
  • Maximum observed plasma drug concentration (Cmax) by inspection (without interpolation) [ Time Frame: 1 Day ]
  • Time to Cmax, by inspection (tmax) [ Time Frame: 1 Day ]
  • Area under the drug concentration by time curve (AUC) from time 0 to infinity (AUC0-∞) [ Time Frame: 1 Day ]
  • AUC from time 0 to the time of the last measurable drug concentration (AUC0-t) [ Time Frame: 1 Day ]
  • AUC from time 0 to 12 hours (AUC0-12) [ Time Frame: 1 Day ]
  • Apparent plasma terminal elimination rate constant (λz) and associated terminal elimination half-life (t½) [ Time Frame: 1 Day ]
  • Percentage extrapolation calculated as (AUC0-∞-AUC0-t)/(AUC0-∞)x100 [ Time Frame: 1 Day ]
  • Apparent plasma clearance (CL/F) [ Time Frame: 1 Day ]
  • Apparent volume of distribution (Vz/F) [ Time Frame: 1 Day ]
  • Predicted accumulation ratio (Rpred) calculated as AUC0-∞/AUC0-12 [ Time Frame: 1 Day ]
  • Summary of participants with adverse events [ Time Frame: 24 Months ]


Original Secondary Outcome: Same as current

Information By: Teva Pharmaceutical Industries

Dates:
Date Received: February 28, 2014
Date Started: May 31, 2014
Date Completion: July 31, 2020
Last Updated: May 12, 2017
Last Verified: May 2017