Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options

  • Interventional
  • Recruiting
  • NCT03583164
Eligibility Details Visit Clinicaltrials.gov

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

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

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.

Gender
All

Age Group
18 Years and up

Accepting 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
  • Invasive Fungal Infections

At a Glance

National Government IDNCT03583164

IRB#IRB18-1357

Lead SponsorF2G Ltd.

Lead PhysicianKathleen Mullane

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting