E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neutropenic patients over 18 years with acute myeloid leukemia (AML). |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 (< 500 ANC/mm3) for > 9 and < 28 days after enrollment. 3. Ability and willingness to comply with the protocol. 4. Patients must be able to understand the content of the informed consent and to follow the instructions of the study personnel. 5. Patients aged over 18 years. Women of childbearing potential must have a negative pregnancy test and must agree to use two methods of contraception during treatment and for one month following treatment. 6. Life expectancy of at least 3 month. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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end of study: Date of last contact with the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |