A Phase III, Randomized, Double-Blind, Comparative Trial of FK463 Versus Fluconazole for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoetic Stem Cell Transplant
The objective of this study is to determine the efficacy and safety of FK463 versus
fluconazole in preventing fungal infections in patients undergoing an autologous (for
hematologic malignancies) or allogeneic hematopoietic stem cell transplant. This is a Phase
III, multicenter, randomized, double-blind study in patients six months of age and older.
Study drug, either FK463 at 50 mg/day (1.0 mg/kg/day in patients weighing less than 50 kg)
or fluconazole at 400 mg/day (8 mg/kg/day in patients weighing less than 50 kg), will be
administered intravenously once daily in a blinded manner. Study drug will continue until
neutrophil recovery (defined as a post nadir absolute neutrophil count (ANC) of greater than
or equal to 500/mm3). Patients who develop a proven, probable, or suspected (requires
empirical antifungal therapy) fungal infection will be discontinued from the prophylactic
regimen. The maximum time the patient may receive study drug is 42 days post transplant.
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
|National Cancer Institute (NCI)||Bethesda, Maryland 20892|