A Study of the Experimental Medicine F901318 for Invasive Fungal Infections in Patients Lacking Treatment Options

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: IFI, invasive fungal infection, Lomentospora prolificans, fungal infection, Scedosporium spp, Aspergillus spp, resistant fungi, resistant fungal infection
Type: Drug study, Phase 2
Target:
3 Participants
Investigator:
Description
We invite you to take part in this research study because your doctor has confirmed, or suspects, that you may have an invasive fungal infection (IFI). An IFI is a severe, life-threatening infection caused by a fungus. This study hopes to learn more about how well the investigational study drug, F901318 (also known as olorofim), is tolerated. We also hope to learn how safe it is for people with invasive fungal infections that have not improved with existing antifungal therapy. The study will also look at how the body processes the study drug (known as “pharmacokinetics”).

The study drug is an experimental or investigational drug. This means the FDA has not approved it for treating IFI.

The experimental study drug is an antifungal medication. It has been developed to treat serious fungal infections. It works by stopping a certain enzyme (protein) that is involved in the process of how fungi develop.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
UC Davis IRB: 1349781
ClinicalTrials.gov: NCT03583164
Schedule
Study duration and period
The length of your participation in the study will depend on how your infection responds to the study drug. The maximum duration of participation is expected to be just over 18 weeks (about 4 months). You will have up to 19 study visits during the study. If your infection clears up during the treatment period, your participation will be shorter and you will have fewer study visits.
Recruitment period
From March 11, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Invasive Fungal Infections