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

NCT ID: NCT00413439

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2007-06-30

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low dose isavuconazole intravenous solution

Group Type: EXPERIMENTAL

Isavuconazole

Intervention Type: DRUG

Intravenous solution or oral capsules

High dose isavuconazole intravenous solution or oral capsules

Group Type: EXPERIMENTAL

Isavuconazole

Intervention Type: DRUG

Intravenous solution or oral capsules

Interventions

Isavuconazole

Intravenous solution or oral capsules

Intervention Type: DRUG

Other Intervention Names

ASP9766; BAL8557

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Cornely, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

Bremen, , Germany

University Cologne

Cologne, , Germany

Frankfurt, , Germany

Mainz, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 25624327 (View on PubMed)

Other Identifiers

2005-005294-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WSA-CS-002

Identifier Type: -

Identifier Source: org_study_id