Neutropenic patients over 18 years with acute myeloid leukemia (AML).
Conditions
Interventions
Product Name: BAL8557
Product Code: BAL8557
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Isavuconazonium Sulfate
Current Sponsor code: BAL8557
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Basilea Pharmaceutica Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with AML and entering first induction treatment or subsequent chemotherapy if no prior invasive fungal infection was observed. 2. Patients are expected to be neutropenic ( 9 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who received any systemic antifugal 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. 2. Patients who received systemic antifugal therapy for proven or probable fungal infection in the last 12 month. 3. Patients with fever defined as central body temperature > 38°C. 4. Pregnancy or breast feeding. 5. Known hypersensitivity to azoles or any component of the study medication. 6. Concomitant use of rifampicin, rifabutin, ergots alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine, and carbamazepine. 7. Hepatic or severe renal dysfunction with any of the following abnormal laboratory parameters: - Total bilirubin > 3 times, alanine transaminase (ALT) or aspartate transaminase (AST) > 5 times the upper limit of the laboratory reference range. - Calculated creatinine clearance (CLcr) < 50 mL/minute. - Patients with a medical history of oliguria (< 20 mL/h) unresponsive to fliud challenge. 8. Patients with a concomitant medical condition that, in the opinion of the investigator, may be an unacceptable additonal risk to the patient should she/he participate in this study 9. Treatment with any investigational drug within 30 days prior to the first administration of study medication except open label chemotherapy protocols. 10. Suspected other or additional cause for neutropenia or immunosuppression, which may affect the clinical evaluability of the patient. 11. Patients previously enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the safety and tolerability of two escalating dosing regimens of intravenous or oral BAL8557 in patients during neutropenia;Secondary Objective: The secondary objectives of this study are - to determine efficacy in prevention of invasive fungal infection - to obtain pharmacokinetic data of BAL8557, BAL4815 and BAL8728 from patients treated with BAL8557 at two escalating doses;Primary end point(s): The primary endpoint is: - Absence of drug-related adverse events. The secondary endpoints are: - Absence of breakthrough infections. - Pharmacokinetic data of BAL8557, BAL4815 and BAL8728 from patients treated with BAL8557 at escalating doses. | — |
Countries
Germany
Outcome results
None listed