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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413439
• Other study ID #: WSA-CS-002
• Secondary ID: 2005-005294-30
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2006
• Est. completion date: June 2007

Study information

• Verified date: May 2023
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Isavuconazole
Intravenous solution or oral capsules

Locations

Country	Name	City	State
Germany	University Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs)		Up to Day 28
Secondary	Efficacy assessed by the frequency of invasive fungal infections		Up to Day 28
Secondary	Pharmacokinetics: drug plasma levels		Up to Day 28