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

May 9, 2023 updated by: Basilea Pharmaceutica

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bremen, Germany
      • Cologne, Germany, 50937
        • University Cologne
      • Frankfurt, Germany
      • Mainz, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy assessed by the frequency of invasive fungal infections
Time Frame: Up to Day 28
Up to Day 28
Pharmacokinetics: drug plasma levels
Time Frame: Up to Day 28
Up to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basilea Pharmaceutica

Investigators

  • Principal Investigator: Oliver Cornely, MD, University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

December 18, 2006

First Submitted That Met QC Criteria

December 18, 2006

First Posted (Estimate)

December 19, 2006

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSA-CS-002
  • 2005-005294-30 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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