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

Study start date: November 1, 1999

Informed consent of the patient or legally authorized representative must be obtained prior to entry. Verbal assent will be obtained from minors capable of understanding. Patients may be of either gender. Females of childbearing potential must have a negative pregnancy test obtained within 14 days prior to the first dose of study drug. Patients greater than or equal to 6 months of age. Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following: Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant; Any patient undergoing an allogeneic hematopoietic stem cell transplant. Patients must have sufficient venous access to permit administration of study drug and monitoring of safety variables. No patients who are pregnant or nursing. Females of childbearing potential must avoid becoming pregnant by abstinence or barrier methods of birth control while receiving antifungal agents. No patients with moderate or severe liver disease, as defined by: AST or ALT greater than 5 times upper limit of normal (ULN), OR; Total bilirubin greater than 2.5 times ULN. No patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment. No patients who have received systemic antifungal agents within 72 hours prior to the first dose of study drug. No patients receiving an autologous transplant for nonhematologic malignancies. No patients known to be infected with HIV due to the lack of data on drug interaction between highly active antiretroviral therapy (HAART) and FK463. No patients previously randomized in this study. No patients with a history of anaphylaxis attributed to azole compounds or the echinocandin class or antifungals. No patients with a concomitant medical condition, in the opinion of the investigator and/or medical monitor, whose participation may create an unacceptable additional risk for the patient. No patients receiving another investigational drug other than for the treatment of cancer or supportive care.