Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy

Basilea Pharmaceutica

Status and phase

Completed

Phase 3

Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Isavuconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00413439

WSA-CS-002

2005-005294-30 (EudraCT Number)

Details and patient eligibility

About

Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections. The study investigates the safety and tolerability of two different dosages, the efficacy in prevention of fungal diseases.

Full description

Patients with Acute Myeloid Leukemia who undergo aggressive chemotherapy are due to immunosuppression susceptible to infections, including fungal infections. As the failure rate in the treatment of invasive fungal infections is high, prophylaxis is frequently recommended. This open label study investigates the safety and tolerability of two different dosages of a water soluble azole antifungal, as well as the efficacy in prevention of invasive fungal infections and pharmacokinetic data.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

diagnosis of acute myeloid leukemia
patients entering first induction treatment; or subsequent chemotherapy if no prior invasive fungal infection was observed
expected to be neutropenic for >9 and <28 days after enrollment
women of childbearing potential must have a negative pregnancy test

Exclusion criteria

patients who received any systemic antifungal therapy for more than 72 hours prior to first administration of study medication. Topical polyenes or nystatin are acceptable but should be discontinued during the study
patients who received systemic antifungal therapy for proven or probable fungal infection in the last 12 months
patients with fever defined as central body temperature of > 38°C
known hypersensitivity to azoles or any component of the study medication
concomitant use of rifampicin, rifabutin, ergots alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine, and carbamazepine
hepatic or severe renal dysfunction
patients with a medical history of oliguria unresponsive to fluid challenge
patients with a concomitant medical condition that may be an unacceptable additional risk to the patient should he/she participate in the study
treatment with any investigational drug within 30 days prior to the first administration of study medication except open label chemotherapy protocols
suspected other or additional cause for neutropenia or immunosuppression