Status:
COMPLETED
Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy
Lead Sponsor:
Basilea Pharmaceutica
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 effic...
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 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00413439
Start Date
May 1 2006
End Date
June 1 2007
Last Update
May 10 2023
Active Locations (4)
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1
Bremen, Germany
2
University Cologne
Cologne, Germany, 50937
3
Frankfurt, Germany
4
Mainz, Germany