drugset / Trial / NCT00936117

Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia

NCT00936117

NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn the amount of posaconazole that is in the body at different time points when given to patients with leukemia. The safety of this drug will also be studied. Objectives: Primary: To study the plasma pharmacokinetics of posaconazole in patients with newly diagnosed acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) undergoing induction chemotherapy or relapsed or refractory patients who will receive salvage chemotherapy. Secondary: To evaluate the safety of posaconazole given as prophylaxis.

Timeline

Start
2009-09
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Posaconazole Small molecule 200 mg Oral