FORMULA-OLS
Research type
Research Study
Full title
An open-label single-arm Phase IIb study of F901318 as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi in patients lacking suitable alternative treatment options.
IRAS ID
269804
Contact name
Paul Newell
Contact email
Sponsor organisation
F2G
Eudract number
2017-001290-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 4 days
Research summary
In this study all eligible patients will receive the investigational medication to evaluate the efficacy, safety, tolerability and pharmacokinetics (how the medication is processed in the body) profile of F901318 in patients with invasive fungal infection (IFI) lacking suitable alternative treatment options. The study has 3 phases; the Screening phase (up to 7 days), the main study phase (up to 90 days) and the extended treatment phase which will be possible to participate after Medical Monitor approval and after up to 90 days of treatment in main study phase. The length of participation in the study will depend on if and how quickly fungal infection responds to the study drug. The maximum duration of participation is expected to be just over 18 weeks (about 4 months) in 19 visits. In case the infection is clinically resolved before, patients will undertake reduced study related visits.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0019
Date of REC Opinion
19 Mar 2020
REC opinion
Further Information Favourable Opinion