Study on Safety and Pharmacokinetics of Intravenous F901318 for Fungal Prophylaxis in AML Patients — SAFEGUARD  

Acute Myeloid Leukemia Clinical Trial

Official title: An Open Label Phase IIa Clinical Study to Evaluate the Safety and Pharmacokinetics of Intravenous and Oral F901318 (Combined With Caspofungin) for Antifungal Prophylaxis in Patients Undergoing Chemotherapy for Acute Myeloid Leukaemia

Status Withdrawn

Clinical Trial Summary

This study assesses the pharmacokinetics and safety of the new antifungal F901318 in AML patients.

Clinical Trial 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 caspofungin will allow recognizing potential factors of suboptimal F901318 exposure without the risk of fatal disseminating infection. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Aspergillosis
• Invasive Pulmonary Aspergillosis
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Pulmonary Aspergillosis
• Pulmonary Aspergillosis - Invasive

• NCT number: NCT02856178
• Study type: Interventional
• Source: F2G Ltd.
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: April 20, 2017
• Completion date: April 20, 2017