NCT00413439

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

Open Label, Multi-center, Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Isavuconazole	Intravenous solution or oral capsules

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2006-12-19
• Last updated: 2023-05-10

Locations

4 sites across 1 country: Germany