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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413439
First Posted: December 19, 2006
Last Update Posted: March 10, 2017
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.
Information provided by (Responsible Party):
Basilea Pharmaceutica
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:
  • Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs) [ Time Frame: Up to Day 28 ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413439


Locations
Germany
Bremen, Germany
University Cologne
Cologne, Germany, 50937
Frankfurt, Germany
Mainz, Germany
Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
Principal Investigator: Oliver Cornely, MD University of Cologne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT00413439     History of Changes
Other Study ID Numbers: WSA-CS-002
2005-005294-30 ( EudraCT Number )
First Submitted: December 18, 2006
First Posted: December 19, 2006
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by Basilea Pharmaceutica:
Isavuconazole
BAL8557
ASP9766
chemotherapy
prophylaxis
systemic fungal infection

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms