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

Sponsor:	Astellas Pharma Inc
Collaborator:	Basilea Pharmaceutica
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00413439

Purpose

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.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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: Acute Myeloid Leukemia Fungal Infections Leukemia Molds

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs) [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy assessed by the frequency of invasive fungal infections [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]
Pharmacokinetics: drug plasma levels [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]

Enrollment:	18
Study Start Date:	May 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Low dose isavuconazole intravenous solution	Drug: Isavuconazole Intravenous solution or oral capsules Other Names: ASP9766 BAL8557
Experimental: High dose isavuconazole intravenous solution or oral capsules	Drug: Isavuconazole Intravenous solution or oral capsules Other Names: ASP9766 BAL8557

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.

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
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

Contacts and Locations

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

Locations

Germany

Bremen, Germany
University Cologne
Cologne, Germany, 50937

Frankfurt, Germany

Mainz, Germany

Sponsors and Collaborators

Astellas Pharma Inc

Basilea Pharmaceutica

Investigators

Principal Investigator:

Oliver Cornely, MD

University of Cologne, Germany

More Information

No publications provided

Responsible Party:	Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier:	NCT00413439 History of Changes
Other Study ID Numbers:	WSA-CS-002, 2005-005294-30
Study First Received:	December 18, 2006
Last Updated:	August 1, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Astellas Pharma Inc:

Isavuconazole
BAL8557
ASP9766

chemotherapy
prophylaxis
systemic fungal infection

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 09, 2012