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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.
Full description
'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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Inclusion criteria
Participating patients need to fulfil all of the following criteria:
Patients diagnosed with AML and entering treatment of chemotherapy.
Patients are expected to be neutropenic (ANC <500/µl) for >10 days.
Provision of written informed consent prior to any study specific procedures.
Ability and willingness to comply with the protocol.
Patients aged over 18 years.
Patients with body weight ≥60 kg
Group F only: patient receives according to local clinical standard either
Group P only: patient receives posaconazole as fungal prophylaxis according to local clinical standard
Exclusion criteria
Any of the following will exclude a patient from the study:
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0 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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