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

This study has been completed.
Sponsor:
Collaborator:
Basilea Pharmaceutica
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00413439
First received: December 18, 2006
Last updated: August 1, 2011
Last verified: August 2011

December 18, 2006
August 1, 2011
May 2006
June 2007   (final data collection date for primary outcome measure)
Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs) [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]
safety and tolerability: (adverse events, laboratory tests, ECGs)
Complete list of historical versions of study NCT00413439 on ClinicalTrials.gov Archive Site
  • 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 ]
  • efficacy: frequency of invasive fungal infections
  • pharmacokinetics: drug plasma levels
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Acute Myeloid Leukemia
Drug: Isavuconazole
Intravenous solution or oral capsules
Other Names:
  • ASP9766
  • BAL8557
  • Experimental: Low dose isavuconazole intravenous solution
    Intervention: Drug: Isavuconazole
  • Experimental: High dose isavuconazole intravenous solution or oral capsules
    Intervention: Drug: Isavuconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00413439
WSA-CS-002, 2005-005294-30
No
Clinical Trials Registry, Astellas Pharma Global Development
Astellas Pharma Inc
Basilea Pharmaceutica
Principal Investigator: Oliver Cornely, MD University of Cologne, Germany
Astellas Pharma Inc
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP