An Open-Label Study to Investigate the Pharmacokinetics (Absorption, Distribution, Metabolism, and Excretion) of Omacetaxine Mepesuccinate Following Subcutaneous Administration of [14C]Omacetaxine Mepesuccinate in Patients With Relapsed and/or Refractory Hematologic Malignancies or Advanced Solid Tumors
This is a Phase 1, single-center, open-label, nonrandomized study to determine the
pharmacokinetics (absorption, distribution, metabolism, and excretion) of omacetaxine and
its metabolites following a sc dosage of 1.25 mg/m2 in adult patients with relapsed and/or
refractory hematologic malignancies or advanced solid tumors. The study consists of a
screening period of up to 28 days, followed by a 7-day pharmacokinetic assessment period
(period A) that includes administration of a single radiolabeled dose of omacetaxine, an
open-label treatment period of up to six 28-day cycles (period B), and a final assessment to
occur approximately 28±7 days after the end of the last treatment cycle. Period B will begin
after collection of the 72-hour pharmacokinetic sample during period A.
Interventional
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum observed plasma drug concentrations (Cmax)
0,15, 30, and 45 minutes and 1, 2, 4, 8, 12, 24, 32, 48, 72, 96,120, 144, and 168 hours post dose
No
United States: Food and Drug Administration
C41443/1103 Study
NCT01844869
May 2013
June 2015
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