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

Sponsor

Basilea Pharmaceutica (Industry)

Overall Status

Completed

CT.gov ID

NCT00413439

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

4.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: Isavuconazole	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

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

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs) [Up to Day 28]

Secondary Outcome Measures

Efficacy assessed by the frequency of invasive fungal infections [Up to Day 28]
Pharmacokinetics: drug plasma levels [Up to Day 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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