Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy
Information source: Basilea Pharmaceutica
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myeloid Leukemia
Intervention: BAL8557 (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Basilea Pharmaceutica Official(s) and/or principal investigator(s):
Oliver Cornely, MD, Principal Investigator, Affiliation: University of Cologne, Germany
Summary
Patients who undergo chemotherapy for leukemia will recieve an antifungal intravenously for
prophylaxis of fungal infections. The study investigates the safet and tolerability of two
different dosages, the efficacy in prevention of fungal diseases and the blood
levels(pharmacokinetics)of the antifungal drug.
Clinical Details
Official title: 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
Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: safety and tolerability: (adverse events, laboratory tests, ECGs)
Secondary outcome: efficacy: frequency of invasive fungal infectionspharmacokinetics: drug plasma levels
Detailed description:
Patients with Acute Myeloid Leukemia who undergo agressive chemotherapy are due to
immunesuppression 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- diagnosis of acute myeloid leukemia
- chemotherapy (induction or subsequent)
- expected to be neutropenic for >9 and < 28 days after enrollment
Exclusion Criteria:
- patients who recieved any systemic antifungal treatment >72h prior to first
administration of study medication
- patients who recieved systemic fungal therapy for proven or probable fungal infection
Locations and Contacts
University Cologne, Cologne 50937, Germany
Bremen, Germany
Mainz, Germany
Frankfurt, Germany
Additional Information
Starting date: May 2006
Ending date: June 2007
Last updated: September 13, 2007
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