Purpose

A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male and female aged 18 or older whom have given informed consent
  • Ability to comply with the protocol
  • Females must be non lactating and not at risk of pregnancy
  • Patients with invasive fungal disease
  • Patients who have limited alternative treatment options

Exclusion Criteria

  • Women who are pregnant or breast feeding
  • Known history of allergy hypersensitivity to any study drug components
  • Patients with chronic aspergillosis
  • HIV patients who are not receiving antiretroviral therapy
  • Previously enrolled patients or patients enrolled in any clinical trial within the last 30 days
  • Patients with a medical condition that may jeopardize adherence to the protocol or may cause unacceptable additional risk to the patient
  • Patients with predicted short survival time
  • Prohibited concomitant medications

Study Design

Phase
Phase 2
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
F901318
open-label single-arm of F901318 as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi which are susceptible to F901318 in patients with limited treatment options.
  • Drug: F901318
    30mg tablets with a maximum daily dose of 300mg with dose adjustments according to plasma levels of F901318 and concomitant treatment with CYP inducers or inhibitors

Recruiting Locations

More Details

Status
Recruiting
Sponsor
F2G Ltd.

Study Contact

Paul Newell
44 07766 130849
PNewell@f2g.com

Detailed Description

This is the first study in patients of F901318. Patients with a limited treatment options will be enrolled and treated with F901318 (olorofim) for up to 12 weeks.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.