NCT03036046

Safety and Pharmacokinetics of Oral F901318 (Fluconazole and Posaconazole) IN Aml Leukaemia

An Open Label Phase IIa Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral F901318 (Combined With Fluconazole and Posaconazole) in AML

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: F2G Biotech GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.'

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	F901318 with fluconazole low dose	adverse events
DRUG	F901318 with fluconazole high dose	adverse events
DRUG	F901318 with posaconazole	adverse events

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-09-01
• Completion: 2018-03-01
• First posted: 2017-01-30
• Last updated: 2018-02-15