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

Primary Purpose

Acute Myeloid Leukemia

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Isavuconazole

About this trial

This is an interventional prevention trial for Acute Myeloid Leukemia focused on measuring Isavuconazole, BAL8557, ASP9766, chemotherapy, prophylaxis, systemic fungal infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Cologne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Low dose isavuconazole intravenous solution

High dose isavuconazole intravenous solution or oral capsules

Arm Description

Outcomes

Primary Outcome Measures

Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs)

Secondary Outcome Measures

Efficacy assessed by the frequency of invasive fungal infections

Pharmacokinetics: drug plasma levels

Full Information

NCT ID

NCT00413439

First Posted

December 18, 2006

Last Updated

May 9, 2023

Sponsor

Basilea Pharmaceutica

1. Study Identification

Unique Protocol Identification Number

NCT00413439

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Basilea Pharmaceutica

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

Isavuconazole, BAL8557, ASP9766, chemotherapy, prophylaxis, systemic fungal infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dose isavuconazole intravenous solution

Arm Type

Experimental

Arm Title

High dose isavuconazole intravenous solution or oral capsules

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Isavuconazole

Other Intervention Name(s)

ASP9766, BAL8557

Intervention Description

Intravenous solution or oral capsules

Primary Outcome Measure Information:

Title

Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs)

Time Frame

Up to Day 28

Secondary Outcome Measure Information:

Title

Efficacy assessed by the frequency of invasive fungal infections

Time Frame

Up to Day 28

Title

Pharmacokinetics: drug plasma levels

Time Frame

Up to Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oliver Cornely, MD

Organizational Affiliation

University of Cologne

Official's Role

Principal Investigator

Facility Information:

City

Bremen

Country

Germany

Facility Name

University Cologne

City

Cologne

ZIP/Postal Code

50937

Country

Germany

City

Frankfurt

Country

Germany

City

Mainz

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25624327

Citation

Cornely OA, Bohme 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.

Results Reference

derived

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

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