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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00413439
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : March 10, 2017
Information provided by (Responsible Party):
Basilea Pharmaceutica

December 18, 2006
December 19, 2006
March 10, 2017
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 ]
safety and tolerability: (adverse events, laboratory tests, ECGs)
Complete list of historical versions of study NCT00413439 on Archive Site
  • Efficacy assessed by the frequency of invasive fungal infections [ Time Frame: Up to Day 28 ]
  • Pharmacokinetics: drug plasma levels [ Time Frame: Up to Day 28 ]
  • 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.
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Cornely OA, Böhme A, Schmitt-Hoffmann A, Ullmann AJ. Safety and pharmacokinetics of isavuconazole as antifungal prophylaxis in acute myeloid leukemia patients with neutropenia: results of a phase 2, dose escalation study. Antimicrob Agents Chemother. 2015 Apr;59(4):2078-85. doi: 10.1128/AAC.04569-14. Epub 2015 Jan 26.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
2005-005294-30 ( EudraCT Number )
Not Provided
Not Provided
Basilea Pharmaceutica
Basilea Pharmaceutica
Not Provided
Principal Investigator: Oliver Cornely, MD University of Cologne
Basilea Pharmaceutica
March 2017

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