Acute Myeloid Leukemia Clinical Trial
Official title:
An Open Label Phase IIa Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral F901318 (Combined With Fluconazole and Posaconazole) in AML
Non-randomized, multi-centre, open label, uncontrolled, multiple dose, phase IIa study.
A total of 18 patients diagnosed with acute myeloid leukaemia (AML) scheduled for
chemotherapy and expected to be neutropenic (<500 Absolute neutrophil count (ANC)/µl) for >10
days will be treated. F901318 will be given in conjunction with fluconazole or posaconzaole
in order to assess safe treatment regimens for both combinations.
'F901318 has potent in vitro efficacy against Aspergillus spp. including azole-resistant
strains and consistent efficacy in in vivo mouse models of infection. F901318 is active by
both oral and intravenous routes of administration in preclinical efficacy studies.
Non-clinical studies and phase I clinical trials show that F901318 has a good overall safety
profile and limited potential for drug-drug interactions. F901318 exhibits a highly promising
profile which can potentially address the critical treatment requirements for invasive
Aspergillus infections in a changing clinical environment in which new classes of antifungals
are needed.
This phase IIa study aims to confirm PK and safety information of F901318 from phase I and
bridge them to a neutropenic AML patient population, which represents the main population for
future efficacy trials. Coadministration of fluconazole or posaconazole will allow
recognizing potential factors of suboptimal F901318 exposure without the risk of fatal
disseminating infection.'
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