Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy - Full Text View

Sponsor:	Basilea Pharmaceutica
Information provided by:	Basilea Pharmaceutica
ClinicalTrials.gov Identifier:	NCT00413439

Purpose

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.

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: BAL8557	Phase II Phase III

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Leukemia, Adult Acute Leukemia, Adult Chronic Molds

U.S. FDA Resources

Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:

safety and tolerability: (adverse events, laboratory tests, ECGs)

Secondary Outcome Measures:

efficacy: frequency of invasive fungal infections
pharmacokinetics: drug plasma levels

Estimated Enrollment:	18
Study Start Date:	May 2006
Study Completion Date:	June 2007

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413439

Locations

Germany
University Cologne
Cologne, Germany, 50937

Bremen, Germany

Mainz, Germany

Frankfurt, Germany

Sponsors and Collaborators

Basilea Pharmaceutica

Investigators

Principal Investigator:

Oliver Cornely, MD

University of Cologne, Germany

More Information

No publications provided

Study ID Numbers:	WSA-CS-002
Study First Received:	December 18, 2006
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00413439 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Basilea Pharmaceutica:

chemotherapy, prophylaxis, systemic fungal infection,

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Leukemia, Myeloid
Leukemia, Myeloid, Acute

ClinicalTrials.gov processed this record on February 08, 2010